<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/NCT03825900</url>
  </required_header>
  <id_info>
    <org_study_id>EA4/221/17</org_study_id>
    <nct_id>NCT03825900</nct_id>
  </id_info>
  <brief_title>Transcranial Direct Current Stimulation and the Interaction Between Chronic Pain and the Intestinal Epithelial Barrier in Patients With Chronic Inflammatory Bowel Diseases (IBD)</brief_title>
  <official_title>Transkranielle Gleichstromstimulation Und Die Interaktion Zwischen Chronischem Schmerz Und Der Intestinalen Epithelbarriere</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the study the investigators aim to test whether transcranial direct current stimulation&#xD;
      (tDCS) induced pain reduction is in association with functional changes in the brain measured&#xD;
      with magnetic resonance imaging (MRI) and also with a change in permeability of the&#xD;
      intestinal epithelial barrier in patients with chronic inflammatory bowel diseases (IBD)&#xD;
&#xD;
      Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in&#xD;
      patients with chronic inflammatory bowel diseases, which is in association with changes in&#xD;
      the brain measured via MRI. Additionally, transcranial direct current stimulation and the&#xD;
      induced pain reduction influence the permeability of the intestinal epithelial barrier&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2022</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional changes in the brain measured with cerebral MRI</measure>
    <time_frame>6 weeks</time_frame>
    <description>Exploratory analyses of resting-state fMRI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Structural changes in the brain measured with cerebral MRI</measure>
    <time_frame>6 weeks</time_frame>
    <description>Exploratory analyses of MRI with respect to DTI (diffusions tensor imaging) and VBM (voxel based morphometry)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional and/or structural changes in the Intestinal Epithelial Barrier measured with endoscopy of the rectum with sample-taking</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in pain measured with visual analogue scale</measure>
    <time_frame>6 weeks</time_frame>
    <description>VAS , scale from 0-10</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in perception of pain measured with an algometer (pain pressure threshold)</measure>
    <time_frame>6 weeks</time_frame>
    <description>continuous scale form 0 kg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in questionnaire &quot;quality of life&quot;</measure>
    <time_frame>6 weeks</time_frame>
    <description>questionnaire &quot;quality of life&quot; analyses daily activities, scale running from 32 points (worse outcome) to 224 points (best outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in functional symptoms using IBS-SSS</measure>
    <time_frame>6 weeks</time_frame>
    <description>IBS-SSS: irritable bowel syndrome - severity score system , questionnaire analyses functional symptoms, score running from 0 (best outcome) until 600 points (worst outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in activity indices using HWI questionnaire or SCCAI questionnaire</measure>
    <time_frame>6 weeks</time_frame>
    <description>HWI: Harvey-Bradshaw-Index, SCCAI: Simple Clinical Colitis Activity Index, scale: points: 0-20 points (low points are best outcome, high points are worst outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in pain catastrophizing scale questionnaire</measure>
    <time_frame>6 weeks</time_frame>
    <description>pain catastrophizing scale questionnaire analyses subjective catastrophizing due to pain, score running from 0-52 points (low points are best outcome, high points are worst outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in inflammation biomarker (blood - C-reactive protein)</measure>
    <time_frame>6 weeks</time_frame>
    <description>unit: mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in inflammation biomarker (stool - calprotectin)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Unit: mg/g</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>Active tDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active transcranial direct current stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham transcranial direct current stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham OR active Transcranial direct current stimulation</intervention_name>
    <description>Sham OR active transcranial direct current stimulation over the motor cortex</description>
    <arm_group_label>Active tDCS</arm_group_label>
    <arm_group_label>Sham tDCS</arm_group_label>
    <other_name>Sham OR active tDCS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inflammatory bowel disease&#xD;
&#xD;
          -  Chronic pain (more than 3 months)&#xD;
&#xD;
          -  Pain (VAS &gt; 3/10)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to transcranial direct current stimulation&#xD;
&#xD;
          -  Contraindications to functional magnetic resonance imaging (fMRI)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Sever internal or psychiatric condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Magdalena S Prüß-Volz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Magdalena S Prüß-Volz, MD</last_name>
    <phone>+493084452718</phone>
    <email>magdalena.pruess@charite.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Charite University Medicine</name>
      <address>
        <city>Berlin</city>
        <zip>12200</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Magdalena S Prüß-Volz, MD</last_name>
      <phone>+493084452718</phone>
      <email>magdalena.pruess@charite.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 25, 2018</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>September 24, 2021</last_update_submitted>
  <last_update_submitted_qc>September 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Magdalena S. Prüß née Volz</investigator_full_name>
    <investigator_title>Principal Investigator, MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03825900
org study id: EA4/221/17
nct id: NCT03825900
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
In the study the investigators aim to test whether transcranial direct current stimulation
      (tDCS) induced pain reduction is in association with functional changes in the brain measured
      with magnetic resonance imaging (MRI) and also with a change in permeability of the
      intestinal epithelial barrier in patients with chronic inflammatory bowel diseases (IBD)

      Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in
      patients with chronic inflammatory bowel diseases, which is in association with changes in
      the brain measured via MRI. Additionally, transcranial direct current stimulation and the
      induced pain reduction influence the permeability of the intestinal epithelial barrier
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Functional changes in the brain measured with cerebral MRI
time frame: 6 weeks
description: Exploratory analyses of resting-state fMRI
measure: Structural changes in the brain measured with cerebral MRI
time frame: 6 weeks
description: Exploratory analyses of MRI with respect to DTI (diffusions tensor imaging) and VBM (voxel based morphometry)
measure: Functional and/or structural changes in the Intestinal Epithelial Barrier measured with endoscopy of the rectum with sample-taking
time frame: 6 weeks
measure: Changes in pain measured with visual analogue scale
time frame: 6 weeks
description: VAS , scale from 0-10
measure: Changes in perception of pain measured with an algometer (pain pressure threshold)
time frame: 6 weeks
description: continuous scale form 0 kg
measure: Changes in questionnaire "quality of life"
time frame: 6 weeks
description: questionnaire "quality of life" analyses daily activities, scale running from 32 points (worse outcome) to 224 points (best outcome)
measure: Changes in functional symptoms using IBS-SSS
time frame: 6 weeks
description: IBS-SSS: irritable bowel syndrome - severity score system , questionnaire analyses functional symptoms, score running from 0 (best outcome) until 600 points (worst outcome)
measure: Changes in activity indices using HWI questionnaire or SCCAI questionnaire
time frame: 6 weeks
description: HWI: Harvey-Bradshaw-Index, SCCAI: Simple Clinical Colitis Activity Index, scale: points: 0-20 points (low points are best outcome, high points are worst outcome)
measure: Changes in pain catastrophizing scale questionnaire
time frame: 6 weeks
description: pain catastrophizing scale questionnaire analyses subjective catastrophizing due to pain, score running from 0-52 points (low points are best outcome, high points are worst outcome)
measure: Changes in inflammation biomarker (blood - C-reactive protein)
time frame: 6 weeks
description: unit: mg/dl
measure: Changes in inflammation biomarker (stool - calprotectin)
time frame: 6 weeks
description: Unit: mg/g
arm group label: Active tDCS
arm group type: Active Comparator
description: Active transcranial direct current stimulation
arm group label: Sham tDCS
arm group type: Sham Comparator
description: Sham transcranial direct current stimulation
intervention type: Device
intervention name: Sham OR active Transcranial direct current stimulation
description: Sham OR active transcranial direct current stimulation over the motor cortex
arm group label: Active tDCS
arm group label: Sham tDCS
other name: Sham OR active tDCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Magdalena S Prüß-Volz, MD
role: Principal Investigator
affiliation: Charite University
last name: Magdalena S Prüß-Volz, MD
phone: +493084452718
email: magdalena.pruess@charite.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Magdalena S. Prüß née Volz
investigator title: Principal Investigator, MD
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases