<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03294616</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00089514</org_study_id>
    <nct_id>NCT03294616</nct_id>
  </id_info>
  <brief_title>Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma</brief_title>
  <official_title>Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      An innovative method of needleless transcutaneous electroacupuncture (TEA) using a newly&#xD;
      developed watch-size stimulator is proposed. Weak electrical current will be delivered via&#xD;
      skin surface electrodes to acupuncture points related to gastrointestinal functions. The&#xD;
      stimulator can be attached to the skin near the acupuncture points and therefore daily&#xD;
      activity of the patient does not need to be altered. Two experiments are designed to prove&#xD;
      the feasibility of the proposed therapy for gastric complications of Scleroderma .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2017</start_date>
  <completion_date type="Actual">November 20, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>effect of TEA on symptoms in Systemic Sclerosis (SSc) patients</measure>
    <time_frame>1 day</time_frame>
    <description>On the first visit; The validated UCLA SCTC GIT2.0 (&quot;University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0&quot;) for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of TEA on symptoms in Systemic Sclerosis (SSc) patients</measure>
    <time_frame>28 days</time_frame>
    <description>On the second visit; The validated &quot;University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0&quot; (UCLA SCTC GIT2.0) for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of TEA on symptoms in Systemic Sclerosis (SSc) patients</measure>
    <time_frame>42 days</time_frame>
    <description>On the third visit; The validated UCLA SCTC GIT2.0 (&quot;University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0&quot;) for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of TEA on symptoms in Systemic Sclerosis (SSc) patients</measure>
    <time_frame>70 days</time_frame>
    <description>The validated UCLA SCTC GIT2.0 (&quot;University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0&quot;) for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of TEA on symptoms in Systemic Sclerosis (SSc) patients</measure>
    <time_frame>1 day</time_frame>
    <description>Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of TEA on symptoms in Systemic Sclerosis (SSc) patients</measure>
    <time_frame>28 days</time_frame>
    <description>Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of TEA on symptoms in Systemic Sclerosis (SSc) patients</measure>
    <time_frame>42 days</time_frame>
    <description>Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of TEA on symptoms in Systemic Sclerosis (SSc) patients</measure>
    <time_frame>70 days</time_frame>
    <description>Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of TEA on symptoms in Systemic Sclerosis (SSc) patients</measure>
    <time_frame>1 day</time_frame>
    <description>SF-36 questionnaire will be used to assess general quality of life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of TEA on symptoms in Systemic Sclerosis (SSc) patients</measure>
    <time_frame>28 days</time_frame>
    <description>SF-36 questionnaire will be used to assess general quality of life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of TEA on symptoms in Systemic Sclerosis (SSc) patients</measure>
    <time_frame>42 days</time_frame>
    <description>SF-36 questionnaire will be used to assess general quality of life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of TEA on symptoms in Systemic Sclerosis (SSc) patients</measure>
    <time_frame>70 days</time_frame>
    <description>SF-36 questionnaire will be used to assess general quality of life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of TEA on symptoms in Systemic Sclerosis (SSc) patients</measure>
    <time_frame>1 day</time_frame>
    <description>a validated method including 9 symptoms will be used to assess GI symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of TEA on symptoms in Systemic Sclerosis (SSc) patients</measure>
    <time_frame>28 days</time_frame>
    <description>a validated method including 9 symptoms will be used to assess GI symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of TEA on symptoms in Systemic Sclerosis (SSc) patients</measure>
    <time_frame>42 days</time_frame>
    <description>a validated method including 9 symptoms will be used to assess GI symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of TEA on symptoms in Systemic Sclerosis (SSc) patients</measure>
    <time_frame>70 days</time_frame>
    <description>a validated method including 9 symptoms will be used to assess GI symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on gastric motility</measure>
    <time_frame>1 week</time_frame>
    <description>visit 1 in acute phase; gastric slow waves recording</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on gastric motility</measure>
    <time_frame>2 weeks</time_frame>
    <description>visit 2 in acute phase; gastric slow waves recording</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on gastric motility</measure>
    <time_frame>3 weeks</time_frame>
    <description>visit 3 in acute phase; gastric slow waves recording</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on gastric motility</measure>
    <time_frame>4 weeks</time_frame>
    <description>visit 4 in acute phase; gastric slow waves recording</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>1 week</time_frame>
    <description>visit 1 in acute phase; heart rate variability recording</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>2 weeks</time_frame>
    <description>visit 2 in acute phase; heart rate variability recording</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>3 weeks</time_frame>
    <description>visit 3 in acute phase; heart rate variability recording</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>4 weeks</time_frame>
    <description>visit 4 in acute phase; heart rate variability recording</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on gastric motility</measure>
    <time_frame>1 day</time_frame>
    <description>visit 1 in chronic phase; gastric slow waves recording</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on gastric motility</measure>
    <time_frame>28 days</time_frame>
    <description>visit 2 in chronic phase; gastric slow waves recording</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on gastric motility</measure>
    <time_frame>42 days</time_frame>
    <description>visit 3 in chronic phase; gastric slow waves recording</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on gastric motility</measure>
    <time_frame>70 days</time_frame>
    <description>visit 4 in chronic phase; gastric slow waves recording</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on gastric motility</measure>
    <time_frame>1 day</time_frame>
    <description>visit 1 in chronic phase; breath test will be used to assess gastric emptying</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on gastric motility</measure>
    <time_frame>28 days</time_frame>
    <description>visit 2 in chronic phase; breath test will be used to assess gastric emptying</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on gastric motility</measure>
    <time_frame>42 days</time_frame>
    <description>visit 3 in chronic phase; breath test will be used to assess gastric emptying</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on gastric motility</measure>
    <time_frame>70 days</time_frame>
    <description>visit 4 in chronic phase; breath test will be used to assess gastric emptying</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>1 day</time_frame>
    <description>visit 1 in chronic phase; heart rate variability recording</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>28 days</time_frame>
    <description>visit 2 in chronic phase; heart rate variability recording</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>42 days</time_frame>
    <description>visit 3 in chronic phase; heart rate variability recording</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>70 days</time_frame>
    <description>visit 4 in chronic phase; heart rate variability recording</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>1 day</time_frame>
    <description>visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>28 days</time_frame>
    <description>visit 2 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>42 days</time_frame>
    <description>visit 3 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>70 days</time_frame>
    <description>visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey visit 4 in chronic phase; will be used to assess autonomic function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>1 day</time_frame>
    <description>baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>28 days</time_frame>
    <description>baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>42 days</time_frame>
    <description>baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>70 days</time_frame>
    <description>baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>1 day</time_frame>
    <description>30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>28 days</time_frame>
    <description>30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>42 days</time_frame>
    <description>30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>70 days</time_frame>
    <description>30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>1 day</time_frame>
    <description>60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>28 days</time_frame>
    <description>60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>42 days</time_frame>
    <description>60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>70 days</time_frame>
    <description>60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>1 day</time_frame>
    <description>baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>28 days</time_frame>
    <description>baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>42 days</time_frame>
    <description>baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>70 days</time_frame>
    <description>baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>1 day</time_frame>
    <description>30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>28 days</time_frame>
    <description>30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>42 days</time_frame>
    <description>30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>70 days</time_frame>
    <description>30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>1 day</time_frame>
    <description>60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>28 days</time_frame>
    <description>60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>42 days</time_frame>
    <description>60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on autonomic function</measure>
    <time_frame>70 days</time_frame>
    <description>60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>1 day</time_frame>
    <description>baseline before the study; vasoactive intestinal peptide (VIP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>28 days</time_frame>
    <description>baseline before the study; vasoactive intestinal peptide (VIP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>42 days</time_frame>
    <description>baseline before the study; vasoactive intestinal peptide (VIP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>70 days</time_frame>
    <description>baseline before the study; vasoactive intestinal peptide (VIP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>1 day</time_frame>
    <description>30 minutes after the testing meal; vasoactive intestinal peptide (VIP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>28 days</time_frame>
    <description>30 minutes after the testing meal; vasoactive intestinal peptide (VIP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>42 days</time_frame>
    <description>30 minutes after the testing meal; vasoactive intestinal peptide (VIP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>70 days</time_frame>
    <description>30 minutes after the testing meal; vasoactive intestinal peptide (VIP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>1 day</time_frame>
    <description>60 minutes after the testing meal; vasoactive intestinal peptide (VIP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>28 days</time_frame>
    <description>60 minutes after the testing meal; vasoactive intestinal peptide (VIP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>42 days</time_frame>
    <description>60 minutes after the testing meal; vasoactive intestinal peptide (VIP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>70 days</time_frame>
    <description>60 minutes after the testing meal; vasoactive intestinal peptide (VIP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>day 1</time_frame>
    <description>baseline before the study; interleukin-10 (IL-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>28 days</time_frame>
    <description>baseline before the study; interleukin-10 (IL-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>42 days</time_frame>
    <description>baseline before the study; interleukin-10 (IL-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>70 days</time_frame>
    <description>baseline before the study; interleukin-10 (IL-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>1 day</time_frame>
    <description>30 minutes after the testing meal; interleukin-10 (IL-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>28 days</time_frame>
    <description>30 minutes after the testing meal; interleukin-10 (IL-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>42 days</time_frame>
    <description>30 minutes after the testing meal; interleukin-10 (IL-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>70 days</time_frame>
    <description>30 minutes after the testing meal; interleukin-10 (IL-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>1 day</time_frame>
    <description>60 minutes after the testing meal; interleukin-10 (IL-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>28 days</time_frame>
    <description>60 minutes after the testing meal; interleukin-10 (IL-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>42 days</time_frame>
    <description>60 minutes after the testing meal; interleukin-10 (IL-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>70 days</time_frame>
    <description>60 minutes after the testing meal; interleukin-10 (IL-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>1 day</time_frame>
    <description>baseline before the study; interferon α(IFNα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>28 days</time_frame>
    <description>baseline before the study; interferon α(IFNα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>42 days</time_frame>
    <description>baseline before the study; interferon α(IFNα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>70 days</time_frame>
    <description>baseline before the study; interferon α(IFNα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>1 day</time_frame>
    <description>30 minutes after the testing meal; interferon α(IFNα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>28 days</time_frame>
    <description>30 minutes after the testing meal; interferon α(IFNα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>42 days</time_frame>
    <description>30 minutes after the testing meal; interferon α(IFNα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>70 days</time_frame>
    <description>30 minutes after the testing meal; interferon α(IFNα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>1 day</time_frame>
    <description>60 minutes after the testing meal; interferon α(IFNα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>28 days</time_frame>
    <description>60 minutes after the testing meal; interferon α(IFNα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>42 days</time_frame>
    <description>60 minutes after the testing meal; interferon α(IFNα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>70 days</time_frame>
    <description>60 minutes after the testing meal; interferon α(IFNα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>1 day</time_frame>
    <description>baseline before the study; interleukin-1 beta (IL-1β)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>28 days</time_frame>
    <description>baseline before the study; interleukin-1 beta (IL-1β)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>42 days</time_frame>
    <description>baseline before the study; interleukin-1 beta (IL-1β)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>70 days</time_frame>
    <description>baseline before the study; interleukin-1 beta (IL-1β)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>1 day</time_frame>
    <description>30 minutes after the testing meal; interleukin-1 beta (IL-1β)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>28 days</time_frame>
    <description>30 minutes after the testing meal; interleukin-1 beta (IL-1β)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>42 days</time_frame>
    <description>30 minutes after the testing meal; interleukin-1 beta (IL-1β)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>70 days</time_frame>
    <description>30 minutes after the testing meal; interleukin-1 beta (IL-1β)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>1 day</time_frame>
    <description>60 minutes after the testing meal; interleukin-1 beta (IL-1β)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>28 days</time_frame>
    <description>60 minutes after the testing meal; interleukin-1 beta (IL-1β)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>42 days</time_frame>
    <description>60 minutes after the testing meal; interleukin-1 beta (IL-1β)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>70 days</time_frame>
    <description>60 minutes after the testing meal; interleukin-1 beta (IL-1β)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>1 day</time_frame>
    <description>baseline before the study; interleukin-6 (IL-6)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>28 days</time_frame>
    <description>baseline before the study; interleukin-6 (IL-6)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>42 days</time_frame>
    <description>baseline before the study; interleukin-6 (IL-6)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>70 days</time_frame>
    <description>baseline before the study; interleukin-6 (IL-6)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>1 day</time_frame>
    <description>30 minutes after the testing meal; interleukin-6 (IL-6)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>28 days</time_frame>
    <description>30 minutes after the testing meal; interleukin-6 (IL-6)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>42 days</time_frame>
    <description>30 minutes after the testing meal; interleukin-6 (IL-6)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>70 days</time_frame>
    <description>30 minutes after the testing meal; interleukin-6 (IL-6)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>1 day</time_frame>
    <description>60 minutes after the testing meal; interleukin-6 (IL-6)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>28 days</time_frame>
    <description>60 minutes after the testing meal; interleukin-6 (IL-6)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>42 days</time_frame>
    <description>60 minutes after the testing meal; interleukin-6 (IL-6)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>70 days</time_frame>
    <description>60 minutes after the testing meal; interleukin-6 (IL-6)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>day 1</time_frame>
    <description>baseline before the study; tumor necrosis factor alpha(TNFα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>28 days</time_frame>
    <description>baseline before the study; tumor necrosis factor alpha(TNFα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>42 days</time_frame>
    <description>baseline before the study; tumor necrosis factor alpha(TNFα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>70 days</time_frame>
    <description>baseline before the study; tumor necrosis factor alpha(TNFα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>1 day</time_frame>
    <description>30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>28 days</time_frame>
    <description>30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>42 days</time_frame>
    <description>30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>70 days</time_frame>
    <description>30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>1 day</time_frame>
    <description>60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>28 days</time_frame>
    <description>60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>42 days</time_frame>
    <description>60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>effects of TEA on GI hormones and inflammatory cytokine</measure>
    <time_frame>70 days</time_frame>
    <description>60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Scleroderma</condition>
  <condition>Gastroparesis</condition>
  <arm_group>
    <arm_group_label>scleroderma patients-0</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>for acute study: The experiment in patients will be performed in 4 randomized sessions on separate days (at least 3 days apart): one control session with sham-TEA and 3 TEA sessions at various parameters. TEA will be applied on both acupoints ST36 and PC6; the following sets of parameters will be tested for TEA at ST36: A) standard parameters: the set used in the previous SSc study: 25 Hz, 0.3ms, 2s-on and 3s-off; B) same as A but pulse width of 0.6ms; C) same as B but 0.1s-on and 0.4s-off. For TEA at PC6, 25 Hz will be replaced by 100Hz because TEA at PC6 is used to treat symptoms and 100Hz is believed to be better than 25Hz. The patient will be fasted overnight, and the test will last 2 hours (1 hour fasting and 1 hour postprandial).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>scleroderma patient-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>for chronic study: 2 weeks of Sham transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>scleroderma patients-2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>for chronic study: 2 weeks of transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcutaneous electroacupuncture</intervention_name>
    <description>Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions</description>
    <arm_group_label>scleroderma patient-1</arm_group_label>
    <arm_group_label>scleroderma patients-0</arm_group_label>
    <arm_group_label>scleroderma patients-2</arm_group_label>
    <other_name>TEA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No any systemic diseases;&#xD;
&#xD;
          -  no scleroderma; no history of gastrointestinal surgery;&#xD;
&#xD;
          -  no dyspeptic symptoms during the past 2 weeks;&#xD;
&#xD;
          -  not taking any medications except contraceptives during the past 2 weeks;&#xD;
&#xD;
          -  age 18 and older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any systemic diseases or surgeries;&#xD;
&#xD;
          -  allergic to adhesives; pregnancy;&#xD;
&#xD;
          -  unable to sign the consent form.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiande Chen, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Bayview Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>November 22, 2019</last_update_submitted>
  <last_update_submitted_qc>November 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>transcutaneous electroacupuncture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroparesis</mesh_term>
    <mesh_term>Scleroderma, Systemic</mesh_term>
    <mesh_term>Scleroderma, Diffuse</mesh_term>
    <mesh_term>Scleroderma, Localized</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>haven't decided yet.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03294616
org study id: IRB00089514
nct id: NCT03294616
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
An innovative method of needleless transcutaneous electroacupuncture (TEA) using a newly
      developed watch-size stimulator is proposed. Weak electrical current will be delivered via
      skin surface electrodes to acupuncture points related to gastrointestinal functions. The
      stimulator can be attached to the skin near the acupuncture points and therefore daily
      activity of the patient does not need to be altered. Two experiments are designed to prove
      the feasibility of the proposed therapy for gastric complications of Scleroderma .
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
time frame: 1 day
description: On the first visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
time frame: 28 days
description: On the second visit; The validated "University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0" (UCLA SCTC GIT2.0) for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
time frame: 42 days
description: On the third visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
time frame: 70 days
description: The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
time frame: 1 day
description: Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
time frame: 28 days
description: Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
time frame: 42 days
description: Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
time frame: 70 days
description: Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
time frame: 1 day
description: SF-36 questionnaire will be used to assess general quality of life
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
time frame: 28 days
description: SF-36 questionnaire will be used to assess general quality of life
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
time frame: 42 days
description: SF-36 questionnaire will be used to assess general quality of life
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
time frame: 70 days
description: SF-36 questionnaire will be used to assess general quality of life
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
time frame: 1 day
description: a validated method including 9 symptoms will be used to assess GI symptoms
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
time frame: 28 days
description: a validated method including 9 symptoms will be used to assess GI symptoms
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
time frame: 42 days
description: a validated method including 9 symptoms will be used to assess GI symptoms
measure: effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
time frame: 70 days
description: a validated method including 9 symptoms will be used to assess GI symptoms
measure: effects of TEA on gastric motility
time frame: 1 week
description: visit 1 in acute phase; gastric slow waves recording
measure: effects of TEA on gastric motility
time frame: 2 weeks
description: visit 2 in acute phase; gastric slow waves recording
measure: effects of TEA on gastric motility
time frame: 3 weeks
description: visit 3 in acute phase; gastric slow waves recording
measure: effects of TEA on gastric motility
time frame: 4 weeks
description: visit 4 in acute phase; gastric slow waves recording
measure: effects of TEA on autonomic function
time frame: 1 week
description: visit 1 in acute phase; heart rate variability recording
measure: effects of TEA on autonomic function
time frame: 2 weeks
description: visit 2 in acute phase; heart rate variability recording
measure: effects of TEA on autonomic function
time frame: 3 weeks
description: visit 3 in acute phase; heart rate variability recording
measure: effects of TEA on autonomic function
time frame: 4 weeks
description: visit 4 in acute phase; heart rate variability recording
measure: effects of TEA on gastric motility
time frame: 1 day
description: visit 1 in chronic phase; gastric slow waves recording
measure: effects of TEA on gastric motility
time frame: 28 days
description: visit 2 in chronic phase; gastric slow waves recording
measure: effects of TEA on gastric motility
time frame: 42 days
description: visit 3 in chronic phase; gastric slow waves recording
measure: effects of TEA on gastric motility
time frame: 70 days
description: visit 4 in chronic phase; gastric slow waves recording
measure: effects of TEA on gastric motility
time frame: 1 day
description: visit 1 in chronic phase; breath test will be used to assess gastric emptying
measure: effects of TEA on gastric motility
time frame: 28 days
description: visit 2 in chronic phase; breath test will be used to assess gastric emptying
measure: effects of TEA on gastric motility
time frame: 42 days
description: visit 3 in chronic phase; breath test will be used to assess gastric emptying
measure: effects of TEA on gastric motility
time frame: 70 days
description: visit 4 in chronic phase; breath test will be used to assess gastric emptying
measure: effects of TEA on autonomic function
time frame: 1 day
description: visit 1 in chronic phase; heart rate variability recording
measure: effects of TEA on autonomic function
time frame: 28 days
description: visit 2 in chronic phase; heart rate variability recording
measure: effects of TEA on autonomic function
time frame: 42 days
description: visit 3 in chronic phase; heart rate variability recording
measure: effects of TEA on autonomic function
time frame: 70 days
description: visit 4 in chronic phase; heart rate variability recording
measure: effects of TEA on autonomic function
time frame: 1 day
description: visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function
measure: effects of TEA on autonomic function
time frame: 28 days
description: visit 2 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function
measure: effects of TEA on autonomic function
time frame: 42 days
description: visit 3 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function
measure: effects of TEA on autonomic function
time frame: 70 days
description: visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey visit 4 in chronic phase; will be used to assess autonomic function
measure: effects of TEA on autonomic function
time frame: 1 day
description: baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 28 days
description: baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 42 days
description: baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 70 days
description: baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 1 day
description: 30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 28 days
description: 30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 42 days
description: 30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 70 days
description: 30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 1 day
description: 60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 28 days
description: 60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 42 days
description: 60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 70 days
description: 60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 1 day
description: baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 28 days
description: baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 42 days
description: baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 70 days
description: baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 1 day
description: 30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 28 days
description: 30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 42 days
description: 30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 70 days
description: 30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 1 day
description: 60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 28 days
description: 60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 42 days
description: 60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on autonomic function
time frame: 70 days
description: 60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 1 day
description: baseline before the study; vasoactive intestinal peptide (VIP)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 28 days
description: baseline before the study; vasoactive intestinal peptide (VIP)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 42 days
description: baseline before the study; vasoactive intestinal peptide (VIP)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 70 days
description: baseline before the study; vasoactive intestinal peptide (VIP)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 1 day
description: 30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 28 days
description: 30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 42 days
description: 30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 70 days
description: 30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 1 day
description: 60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 28 days
description: 60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 42 days
description: 60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 70 days
description: 60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: day 1
description: baseline before the study; interleukin-10 (IL-10)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 28 days
description: baseline before the study; interleukin-10 (IL-10)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 42 days
description: baseline before the study; interleukin-10 (IL-10)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 70 days
description: baseline before the study; interleukin-10 (IL-10)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 1 day
description: 30 minutes after the testing meal; interleukin-10 (IL-10)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 28 days
description: 30 minutes after the testing meal; interleukin-10 (IL-10)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 42 days
description: 30 minutes after the testing meal; interleukin-10 (IL-10)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 70 days
description: 30 minutes after the testing meal; interleukin-10 (IL-10)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 1 day
description: 60 minutes after the testing meal; interleukin-10 (IL-10)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 28 days
description: 60 minutes after the testing meal; interleukin-10 (IL-10)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 42 days
description: 60 minutes after the testing meal; interleukin-10 (IL-10)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 70 days
description: 60 minutes after the testing meal; interleukin-10 (IL-10)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 1 day
description: baseline before the study; interferon α(IFNα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 28 days
description: baseline before the study; interferon α(IFNα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 42 days
description: baseline before the study; interferon α(IFNα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 70 days
description: baseline before the study; interferon α(IFNα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 1 day
description: 30 minutes after the testing meal; interferon α(IFNα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 28 days
description: 30 minutes after the testing meal; interferon α(IFNα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 42 days
description: 30 minutes after the testing meal; interferon α(IFNα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 70 days
description: 30 minutes after the testing meal; interferon α(IFNα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 1 day
description: 60 minutes after the testing meal; interferon α(IFNα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 28 days
description: 60 minutes after the testing meal; interferon α(IFNα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 42 days
description: 60 minutes after the testing meal; interferon α(IFNα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 70 days
description: 60 minutes after the testing meal; interferon α(IFNα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 1 day
description: baseline before the study; interleukin-1 beta (IL-1β)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 28 days
description: baseline before the study; interleukin-1 beta (IL-1β)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 42 days
description: baseline before the study; interleukin-1 beta (IL-1β)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 70 days
description: baseline before the study; interleukin-1 beta (IL-1β)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 1 day
description: 30 minutes after the testing meal; interleukin-1 beta (IL-1β)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 28 days
description: 30 minutes after the testing meal; interleukin-1 beta (IL-1β)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 42 days
description: 30 minutes after the testing meal; interleukin-1 beta (IL-1β)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 70 days
description: 30 minutes after the testing meal; interleukin-1 beta (IL-1β)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 1 day
description: 60 minutes after the testing meal; interleukin-1 beta (IL-1β)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 28 days
description: 60 minutes after the testing meal; interleukin-1 beta (IL-1β)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 42 days
description: 60 minutes after the testing meal; interleukin-1 beta (IL-1β)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 70 days
description: 60 minutes after the testing meal; interleukin-1 beta (IL-1β)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 1 day
description: baseline before the study; interleukin-6 (IL-6)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 28 days
description: baseline before the study; interleukin-6 (IL-6)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 42 days
description: baseline before the study; interleukin-6 (IL-6)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 70 days
description: baseline before the study; interleukin-6 (IL-6)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 1 day
description: 30 minutes after the testing meal; interleukin-6 (IL-6)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 28 days
description: 30 minutes after the testing meal; interleukin-6 (IL-6)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 42 days
description: 30 minutes after the testing meal; interleukin-6 (IL-6)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 70 days
description: 30 minutes after the testing meal; interleukin-6 (IL-6)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 1 day
description: 60 minutes after the testing meal; interleukin-6 (IL-6)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 28 days
description: 60 minutes after the testing meal; interleukin-6 (IL-6)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 42 days
description: 60 minutes after the testing meal; interleukin-6 (IL-6)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 70 days
description: 60 minutes after the testing meal; interleukin-6 (IL-6)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: day 1
description: baseline before the study; tumor necrosis factor alpha(TNFα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 28 days
description: baseline before the study; tumor necrosis factor alpha(TNFα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 42 days
description: baseline before the study; tumor necrosis factor alpha(TNFα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 70 days
description: baseline before the study; tumor necrosis factor alpha(TNFα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 1 day
description: 30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 28 days
description: 30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 42 days
description: 30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 70 days
description: 30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 1 day
description: 60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 28 days
description: 60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 42 days
description: 60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
measure: effects of TEA on GI hormones and inflammatory cytokine
time frame: 70 days
description: 60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
arm group label: scleroderma patients-0
arm group type: Experimental
description: for acute study: The experiment in patients will be performed in 4 randomized sessions on separate days (at least 3 days apart): one control session with sham-TEA and 3 TEA sessions at various parameters. TEA will be applied on both acupoints ST36 and PC6; the following sets of parameters will be tested for TEA at ST36: A) standard parameters: the set used in the previous SSc study: 25 Hz, 0.3ms, 2s-on and 3s-off; B) same as A but pulse width of 0.6ms; C) same as B but 0.1s-on and 0.4s-off. For TEA at PC6, 25 Hz will be replaced by 100Hz because TEA at PC6 is used to treat symptoms and 100Hz is believed to be better than 25Hz. The patient will be fasted overnight, and the test will last 2 hours (1 hour fasting and 1 hour postprandial).
arm group label: scleroderma patient-1
arm group type: Experimental
description: for chronic study: 2 weeks of Sham transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used.
arm group label: scleroderma patients-2
arm group type: Experimental
description: for chronic study: 2 weeks of transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used.
intervention type: Device
intervention name: transcutaneous electroacupuncture
description: Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions
arm group label: scleroderma patient-1
arm group label: scleroderma patients-0
arm group label: scleroderma patients-2
other name: TEA
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jiande Chen, Ph.D
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Gastroparesis
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
mesh term: Scleroderma, Localized
sharing ipd: Undecided
ipd description: haven't decided yet.