xml: <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/NCT05987813</url>
    </required_header>
    <id_info>
      <org_study_id>HM20025635</org_study_id>
      <nct_id>NCT05987813</nct_id>
    </id_info>
    <brief_title>Transcutaneous Electric Nerve Stimulation (TENS) for Vagal Modulation</brief_title>
    <official_title>A Pilot Study of Randomized Auricular Microstimulation to Determine if it Improves Vagal Modulation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Virginia Commonwealth University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Virginia Commonwealth University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is to determine if the auricular microstimulator produces the expected increase in&#xD;
        HRV.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of this proposal is to determine if utilizing an affordable tool like&#xD;
        microstimulation utilizing a transcutaneous electric nerve stimulator (TENS) unit and&#xD;
        applying the stimulation to the ear though an ear clip does improve vagal modulation. This&#xD;
        can be easily done at home by utilizing the microstimulation for 2 or 4 hours/day and&#xD;
        measuring vagal modulation before and after. Previous research investigating this had&#xD;
        participants use the unit for 2 hours. (Chelimsky et al., 2019). The data from this study was&#xD;
        inconclusive, and by adding the 4 hour condition, this project can investigate if the&#xD;
        inconclusive data was due to poor compliance or the need for a longer duration of use to&#xD;
        improve vagal modulation.&#xD;
  &#xD;
        Although functional gastrointestinal disorders (FGID) affect 10%-20% of children and&#xD;
        adolescents. 1-3 the pathophysiology remains unknown. The multiple current hypotheses include&#xD;
        visceral hypersensitivity, altered brain-gut connections, dysbiosis, genetic and epigenetic&#xD;
        factors, and increased gut permeability among others. 4 Since the vagus nerve links the brain&#xD;
        to the gut, many studies of adult subjects have evaluated the cardiovagal modulation in this&#xD;
        group of disorders. The cardiovagal modulation can be measured by heart rate variability&#xD;
        (HRV). HRV evaluates the heart rate fluctuation over a period of time. HRV is considered a&#xD;
        reliable tool to look at parasympathetic function, baroreflex function, and parasympathetic&#xD;
        to sympathetic balance.5, 6 High-frequency (hf) HRV is a marker of vagal modulation. The&#xD;
        low-frequency (lf) HRV probably reflects cardiac autonomic outflow from the baroreflex or&#xD;
        parasympathetic regulation, rather than sympathetic modulation, although this is still being&#xD;
        discussed.6, 7&#xD;
  &#xD;
        A meta-analysis of adult subjects with irritable bowel syndrome (IBS) showed decreased&#xD;
        cardiovagal modulation.8 One study compared children aged 7-10 years of age with functional&#xD;
        abdominal pain or IBS to healthy subjects. They found no difference in cardiovagal and&#xD;
        cardiac sympathetic modulation.9 However, a study of young adolescents with different chronic&#xD;
        pain syndromes, including chronic abdominal pain, showed decreased cardiovagal modulation.10&#xD;
        These findings are similar to those in many adult syndromes with chronic pain, such as&#xD;
        chronic pelvic pain,11 complex regional pain syndrome,12 fibromyalgia,13 and chronic neck&#xD;
        pain.14&#xD;
  &#xD;
        Although future research would aim to investigate vagal modulation in those specifically with&#xD;
        FGID, for preliminary data purposes we are testing the unit's effects on heart rate&#xD;
        variability regardless of having/not having an FGID diagnosis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</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>Parallel Assignment</intervention_model>
      <intervention_model_description>FGID group, non-FGID group. Randomized to 2 or 4 hours of daily TENS usage</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in high-frequency heart rate variability (hfHRV) at 4 weeks</measure>
      <time_frame>Assessed at baseline and 4 weeks.</time_frame>
      <description>Determine if microstimulation to the conchae of the ear over a 4 week period results in improvement in hfHRV.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in high-frequency heart rate variability (hfHRV) after 4 weeks of TENS use Determine if 4 hours/day of microstimulation increases hfHRV more significantly than 2 hours/day over a 4-week period</measure>
      <time_frame>Assessed at baseline and 4 weeks.</time_frame>
      <description>Determine if 4 hours/day of microstimulation increases hfHRV more significantly than 2 hours/day over a 4-week period</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of feasibility with daily TENS usage</measure>
      <time_frame>Assessed daily for duration of study (4 weeks) via self-report recording journal.</time_frame>
      <description>Determine the feasibility of utilizing a microstimulator in adolescents.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of compliance with daily TENS usage</measure>
      <time_frame>Assessed daily for duration of study (4 weeks) via self-report recording journal.</time_frame>
      <description>Determine the compliance rate of adolescents utilizing a microstimulator.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Functional Gastrointestinal Disorders</condition>
    <arm_group>
      <arm_group_label>FGID</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with a FGID</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-FGID</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients without a FGID</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>TENS Unit</intervention_name>
      <description>Usage of the Transcutaneous Electrical Nerve Stimulation device for either 2 or 4 hours a day depending on randomization.</description>
      <arm_group_label>FGID</arm_group_label>
      <arm_group_label>Non-FGID</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female&#xD;
  &#xD;
            -  12 - 18 years old&#xD;
  &#xD;
            -  Either diagnosed OR not diagnosed with chronic idiopathic nausea, functional abdominal&#xD;
               pain, dyspepsia and/or irritable bowel syndrome.&#xD;
  &#xD;
            -  English speaking&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who are unable to stand upright during the heart rate variability recording&#xD;
  &#xD;
            -  Patients with a known bleeding disorder&#xD;
  &#xD;
            -  Patients with swollen, infected, inflamed, or other skin eruptions on outer ear&#xD;
  &#xD;
            -  Patients with epilepsy&#xD;
  &#xD;
            -  Patients with any implanted cardiac pacemaker or defibrillator&#xD;
  &#xD;
            -  Patients with serious arterial circulatory problems in the lower limbs&#xD;
  &#xD;
            -  Patients with abdominal or inguinal hernia&#xD;
  &#xD;
            -  Patients who are pregnant&#xD;
  &#xD;
            -  Any unstable medical condition, such as renal disease, uncontrolled diabetes, etc.&#xD;
  &#xD;
            -  Requires new medication during the 4 weeks of the study that may affect the&#xD;
               gastrointestinal symptoms, vagal modulation or immune response.&#xD;
  &#xD;
            -  Practices over 1 hour of aerobic activity a day&#xD;
  &#xD;
            -  Daily practice of abdominal breathing (yoga)&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gisela Chelimsky, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>VCU</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Madison Maxwell, BS</last_name>
      <phone>8048280290</phone>
      <email>madison.maxwell@vcuhealth.org</email>
    </overall_contact>
    <reference>
      <citation>Hyams JS, Davis P, Sylvester FA, Zeiter DK, Justinich CJ, Lerer T. Dyspepsia in children and adolescents: a prospective study. J Pediatr Gastroenterol Nutr. 2000 Apr;30(4):413-8. doi: 10.1097/00005176-200004000-00012.</citation>
      <PMID>10776953</PMID>
    </reference>
    <reference>
      <citation>APLEY J, NAISH N. Recurrent abdominal pains: a field survey of 1,000 school children. Arch Dis Child. 1958 Apr;33(168):165-70. doi: 10.1136/adc.33.168.165. No abstract available.</citation>
      <PMID>13534750</PMID>
    </reference>
    <reference>
      <citation>Boey C, Yap S, Goh KL. The prevalence of recurrent abdominal pain in 11- to 16-year-old Malaysian schoolchildren. J Paediatr Child Health. 2000 Apr;36(2):114-6. doi: 10.1046/j.1440-1754.2000.00465.x.</citation>
      <PMID>10760006</PMID>
    </reference>
    <reference>
      <citation>Enck P, Aziz Q, Barbara G, Farmer AD, Fukudo S, Mayer EA, Niesler B, Quigley EM, Rajilic-Stojanovic M, Schemann M, Schwille-Kiuntke J, Simren M, Zipfel S, Spiller RC. Irritable bowel syndrome. Nat Rev Dis Primers. 2016 Mar 24;2:16014. doi: 10.1038/nrdp.2016.14.</citation>
      <PMID>27159638</PMID>
    </reference>
    <reference>
      <citation>Riganello F, Garbarino S, Sannita WG. Heart Rate Variability, Homeostasis, and Brain Function. J Psychophysiol. 2012; 26: 178- 203.</citation>
    </reference>
    <reference>
      <citation>Goldstein DS, Bentho O, Park MY, Sharabi Y. Low-frequency power of heart rate variability is not a measure of cardiac sympathetic tone but may be a measure of modulation of cardiac autonomic outflows by baroreflexes. Exp Physiol. 2011 Dec;96(12):1255-61. doi: 10.1113/expphysiol.2010.056259. Epub 2011 Sep 2.</citation>
      <PMID>21890520</PMID>
    </reference>
    <reference>
      <citation>Reyes del Paso GA, Langewitz W, Mulder LJ, van Roon A, Duschek S. The utility of low frequency heart rate variability as an index of sympathetic cardiac tone: a review with emphasis on a reanalysis of previous studies. Psychophysiology. 2013 May;50(5):477-87. doi: 10.1111/psyp.12027. Epub 2013 Feb 27.</citation>
      <PMID>23445494</PMID>
    </reference>
    <reference>
      <citation>Liu Q, Wang EM, Yan XJ, Chen SL. Autonomic functioning in irritable bowel syndrome measured by heart rate variability: a meta-analysis. J Dig Dis. 2013 Dec;14(12):638-46. doi: 10.1111/1751-2980.12092.</citation>
      <PMID>23927739</PMID>
    </reference>
    <reference>
      <citation>Jarrett M, Heitkemper M, Czyzewski D, Zeltzer L, Shulman RJ. Autonomic nervous system function in young children with functional abdominal pain or irritable bowel syndrome. J Pain. 2012 May;13(5):477-84. doi: 10.1016/j.jpain.2012.02.007. Epub 2012 Apr 20.</citation>
      <PMID>22520688</PMID>
    </reference>
    <reference>
      <citation>Evans S, Seidman LC, Tsao JC, Lung KC, Zeltzer LK, Naliboff BD. Heart rate variability as a biomarker for autonomic nervous system response differences between children with chronic pain and healthy control children. J Pain Res. 2013 Jun 12;6:449-57. doi: 10.2147/JPR.S43849. Print 2013.</citation>
      <PMID>23788839</PMID>
    </reference>
    <reference>
      <citation>Williams DP, Chelimsky G, McCabe NP, Koenig J, Singh P, Janata J, Thayer JF, Buffington CA, Chelimsky T. Effects of Chronic Pelvic Pain on Heart Rate Variability in Women. J Urol. 2015 Nov;194(5):1289-94. doi: 10.1016/j.juro.2015.04.101. Epub 2015 May 9.</citation>
      <PMID>25963185</PMID>
    </reference>
    <reference>
      <citation>Mork PJ, Nilsson J, Loras HW, Riva R, Lundberg U, Westgaard RH. Heart rate variability in fibromyalgia patients and healthy controls during non-REM and REM sleep: a case-control study. Scand J Rheumatol. 2013;42(6):505-8. doi: 10.3109/03009742.2012.755564. Epub 2013 Feb 20.</citation>
      <PMID>23425526</PMID>
    </reference>
    <reference>
      <citation>Terkelsen AJ, Molgaard H, Hansen J, Finnerup NB, Kroner K, Jensen TS. Heart rate variability in complex regional pain syndrome during rest and mental and orthostatic stress. Anesthesiology. 2012 Jan;116(1):133-46. doi: 10.1097/ALN.0b013e31823bbfb0.</citation>
      <PMID>22089824</PMID>
    </reference>
    <reference>
      <citation>Kang JH, Chen HS, Chen SC, Jaw FS. Disability in patients with chronic neck pain: heart rate variability analysis and cluster analysis. Clin J Pain. 2012 Nov-Dec;28(9):797-803. doi: 10.1097/AJP.0b013e3182442afd.</citation>
      <PMID>22751023</PMID>
    </reference>
    <reference>
      <citation>Chelimsky G, Rausch S, Bierer D, Feng M, Simpson P, Awe E, Chelimsky T. Cardiovagal modulation in pediatric functional gastrointestinal disorders. Neurogastroenterol Motil. 2019 May;31(5):e13564. doi: 10.1111/nmo.13564. Epub 2019 Mar 27.</citation>
      <PMID>30916860</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gastrointestinal Diseases</mesh_term>
      <mesh_term>Digestive System Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Anonymized information may be shared to other researchers for future relevant projects.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05987813
  org study id: HM20025635
  nct id: NCT05987813
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  This study is to determine if the auricular microstimulator produces the expected increase in
        HRV.
  The aim of this proposal is to determine if utilizing an affordable tool like
        microstimulation utilizing a transcutaneous electric nerve stimulator (TENS) unit and
        applying the stimulation to the ear though an ear clip does improve vagal modulation. This
        can be easily done at home by utilizing the microstimulation for 2 or 4 hours/day and
        measuring vagal modulation before and after. Previous research investigating this had
        participants use the unit for 2 hours. (Chelimsky et al., 2019). The data from this study was
        inconclusive, and by adding the 4 hour condition, this project can investigate if the
        inconclusive data was due to poor compliance or the need for a longer duration of use to
        improve vagal modulation.
  
        Although functional gastrointestinal disorders (FGID) affect 10%-20% of children and
        adolescents. 1-3 the pathophysiology remains unknown. The multiple current hypotheses include
        visceral hypersensitivity, altered brain-gut connections, dysbiosis, genetic and epigenetic
        factors, and increased gut permeability among others. 4 Since the vagus nerve links the brain
        to the gut, many studies of adult subjects have evaluated the cardiovagal modulation in this
        group of disorders. The cardiovagal modulation can be measured by heart rate variability
        (HRV). HRV evaluates the heart rate fluctuation over a period of time. HRV is considered a
        reliable tool to look at parasympathetic function, baroreflex function, and parasympathetic
        to sympathetic balance.5, 6 High-frequency (hf) HRV is a marker of vagal modulation. The
        low-frequency (lf) HRV probably reflects cardiac autonomic outflow from the baroreflex or
        parasympathetic regulation, rather than sympathetic modulation, although this is still being
        discussed.6, 7
  
        A meta-analysis of adult subjects with irritable bowel syndrome (IBS) showed decreased
        cardiovagal modulation.8 One study compared children aged 7-10 years of age with functional
        abdominal pain or IBS to healthy subjects. They found no difference in cardiovagal and
        cardiac sympathetic modulation.9 However, a study of young adolescents with different chronic
        pain syndromes, including chronic abdominal pain, showed decreased cardiovagal modulation.10
        These findings are similar to those in many adult syndromes with chronic pain, such as
        chronic pelvic pain,11 complex regional pain syndrome,12 fibromyalgia,13 and chronic neck
        pain.14
  
        Although future research would aim to investigate vagal modulation in those specifically with
        FGID, for preliminary data purposes we are testing the unit's effects on heart rate
        variability regardless of having/not having an FGID diagnosis.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: FGID group, non-FGID group. Randomized to 2 or 4 hours of daily TENS usage
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in high-frequency heart rate variability (hfHRV) at 4 weeks
  time frame: Assessed at baseline and 4 weeks.
  description: Determine if microstimulation to the conchae of the ear over a 4 week period results in improvement in hfHRV.
  measure: Change in high-frequency heart rate variability (hfHRV) after 4 weeks of TENS use Determine if 4 hours/day of microstimulation increases hfHRV more significantly than 2 hours/day over a 4-week period
  time frame: Assessed at baseline and 4 weeks.
  description: Determine if 4 hours/day of microstimulation increases hfHRV more significantly than 2 hours/day over a 4-week period
  measure: Rate of feasibility with daily TENS usage
  time frame: Assessed daily for duration of study (4 weeks) via self-report recording journal.
  description: Determine the feasibility of utilizing a microstimulator in adolescents.
  measure: Rate of compliance with daily TENS usage
  time frame: Assessed daily for duration of study (4 weeks) via self-report recording journal.
  description: Determine the compliance rate of adolescents utilizing a microstimulator.
  arm group label: FGID
  arm group type: Experimental
  description: Patients with a FGID
  arm group label: Non-FGID
  arm group type: Experimental
  description: Patients without a FGID
  intervention type: Device
  intervention name: TENS Unit
  description: Usage of the Transcutaneous Electrical Nerve Stimulation device for either 2 or 4 hours a day depending on randomization.
  arm group label: FGID
  arm group label: Non-FGID
  criteria: 
  gender: Female
  minimum age: 12 Years
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gisela Chelimsky, MD
  role: Principal Investigator
  affiliation: VCU
  last name: Madison Maxwell, BS
  phone: 8048280290
  email: madison.maxwell@vcuhealth.org
  citation: Hyams JS, Davis P, Sylvester FA, Zeiter DK, Justinich CJ, Lerer T. Dyspepsia in children and adolescents: a prospective study. J Pediatr Gastroenterol Nutr. 2000 Apr;30(4):413-8. doi: 10.1097/00005176-200004000-00012.
  PMID: 10776953
  citation: APLEY J, NAISH N. Recurrent abdominal pains: a field survey of 1,000 school children. Arch Dis Child. 1958 Apr;33(168):165-70. doi: 10.1136/adc.33.168.165. No abstract available.
  PMID: 13534750
  citation: Boey C, Yap S, Goh KL. The prevalence of recurrent abdominal pain in 11- to 16-year-old Malaysian schoolchildren. J Paediatr Child Health. 2000 Apr;36(2):114-6. doi: 10.1046/j.1440-1754.2000.00465.x.
  PMID: 10760006
  citation: Enck P, Aziz Q, Barbara G, Farmer AD, Fukudo S, Mayer EA, Niesler B, Quigley EM, Rajilic-Stojanovic M, Schemann M, Schwille-Kiuntke J, Simren M, Zipfel S, Spiller RC. Irritable bowel syndrome. Nat Rev Dis Primers. 2016 Mar 24;2:16014. doi: 10.1038/nrdp.2016.14.
  PMID: 27159638
  citation: Riganello F, Garbarino S, Sannita WG. Heart Rate Variability, Homeostasis, and Brain Function. J Psychophysiol. 2012; 26: 178- 203.
  citation: Goldstein DS, Bentho O, Park MY, Sharabi Y. Low-frequency power of heart rate variability is not a measure of cardiac sympathetic tone but may be a measure of modulation of cardiac autonomic outflows by baroreflexes. Exp Physiol. 2011 Dec;96(12):1255-61. doi: 10.1113/expphysiol.2010.056259. Epub 2011 Sep 2.
  PMID: 21890520
  citation: Reyes del Paso GA, Langewitz W, Mulder LJ, van Roon A, Duschek S. The utility of low frequency heart rate variability as an index of sympathetic cardiac tone: a review with emphasis on a reanalysis of previous studies. Psychophysiology. 2013 May;50(5):477-87. doi: 10.1111/psyp.12027. Epub 2013 Feb 27.
  PMID: 23445494
  citation: Liu Q, Wang EM, Yan XJ, Chen SL. Autonomic functioning in irritable bowel syndrome measured by heart rate variability: a meta-analysis. J Dig Dis. 2013 Dec;14(12):638-46. doi: 10.1111/1751-2980.12092.
  PMID: 23927739
  citation: Jarrett M, Heitkemper M, Czyzewski D, Zeltzer L, Shulman RJ. Autonomic nervous system function in young children with functional abdominal pain or irritable bowel syndrome. J Pain. 2012 May;13(5):477-84. doi: 10.1016/j.jpain.2012.02.007. Epub 2012 Apr 20.
  PMID: 22520688
  citation: Evans S, Seidman LC, Tsao JC, Lung KC, Zeltzer LK, Naliboff BD. Heart rate variability as a biomarker for autonomic nervous system response differences between children with chronic pain and healthy control children. J Pain Res. 2013 Jun 12;6:449-57. doi: 10.2147/JPR.S43849. Print 2013.
  PMID: 23788839
  citation: Williams DP, Chelimsky G, McCabe NP, Koenig J, Singh P, Janata J, Thayer JF, Buffington CA, Chelimsky T. Effects of Chronic Pelvic Pain on Heart Rate Variability in Women. J Urol. 2015 Nov;194(5):1289-94. doi: 10.1016/j.juro.2015.04.101. Epub 2015 May 9.
  PMID: 25963185
  citation: Mork PJ, Nilsson J, Loras HW, Riva R, Lundberg U, Westgaard RH. Heart rate variability in fibromyalgia patients and healthy controls during non-REM and REM sleep: a case-control study. Scand J Rheumatol. 2013;42(6):505-8. doi: 10.3109/03009742.2012.755564. Epub 2013 Feb 20.
  PMID: 23425526
  citation: Terkelsen AJ, Molgaard H, Hansen J, Finnerup NB, Kroner K, Jensen TS. Heart rate variability in complex regional pain syndrome during rest and mental and orthostatic stress. Anesthesiology. 2012 Jan;116(1):133-46. doi: 10.1097/ALN.0b013e31823bbfb0.
  PMID: 22089824
  citation: Kang JH, Chen HS, Chen SC, Jaw FS. Disability in patients with chronic neck pain: heart rate variability analysis and cluster analysis. Clin J Pain. 2012 Nov-Dec;28(9):797-803. doi: 10.1097/AJP.0b013e3182442afd.
  PMID: 22751023
  citation: Chelimsky G, Rausch S, Bierer D, Feng M, Simpson P, Awe E, Chelimsky T. Cardiovagal modulation in pediatric functional gastrointestinal disorders. Neurogastroenterol Motil. 2019 May;31(5):e13564. doi: 10.1111/nmo.13564. Epub 2019 Mar 27.
  PMID: 30916860
  responsible party type: Sponsor
  mesh term: Gastrointestinal Diseases
  mesh term: Digestive System Diseases
  sharing ipd: No
  ipd description: Anonymized information may be shared to other researchers for future relevant projects.