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Transcranial Direct Current Stimulation and the Interaction Between Chronic Pain and the Intestinal Epithelial Barrier in Patients With Chronic Inflammatory Bowel Diseases (IBD)

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Recruiting
CT.gov ID
NCT03825900
Collaborator
German Research Foundation (Other)
84
Enrollment
1
Location
2
Arms
55
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Sham OR active Transcranial direct current stimulation
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Transkranielle Gleichstromstimulation Und Die Interaktion Zwischen Chronischem Schmerz Und Der Intestinalen Epithelbarriere
Actual Study Start Date :
Jun 1, 2018
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active tDCS

Active transcranial direct current stimulation

Device: Sham OR active Transcranial direct current stimulation
Sham OR active transcranial direct current stimulation over the motor cortex
Other Names:
  • Sham OR active tDCS

    		•
    Sham Comparator: Sham tDCS

    Sham transcranial direct current stimulation

    Device: Sham OR active Transcranial direct current stimulation
    Sham OR active transcranial direct current stimulation over the motor cortex
    Other Names:
  • Sham OR active tDCS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Functional changes in the brain measured with cerebral MRI [6 weeks]

      Exploratory analyses of resting-state fMRI

    2. Structural changes in the brain measured with cerebral MRI [6 weeks]

      Exploratory analyses of MRI with respect to DTI (diffusions tensor imaging) and VBM (voxel based morphometry)

    3. Functional and/or structural changes in the Intestinal Epithelial Barrier measured with endoscopy of the rectum with sample-taking [6 weeks]

    4. Changes in pain measured with visual analogue scale [6 weeks]

      VAS , scale from 0-10

    5. Changes in perception of pain measured with an algometer (pain pressure threshold) [6 weeks]

      continuous scale form 0 kg

    Secondary Outcome Measures

    1. Changes in questionnaire "quality of life" [6 weeks]

      questionnaire "quality of life" analyses daily activities, scale running from 32 points (worse outcome) to 224 points (best outcome)

    2. Changes in functional symptoms using IBS-SSS [6 weeks]

      IBS-SSS: irritable bowel syndrome - severity score system , questionnaire analyses functional symptoms, score running from 0 (best outcome) until 600 points (worst outcome)

    3. Changes in activity indices using HWI questionnaire or SCCAI questionnaire [6 weeks]

      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)

    4. Changes in pain catastrophizing scale questionnaire [6 weeks]

      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)

    5. Changes in inflammation biomarker (blood - C-reactive protein) [6 weeks]

      unit: mg/dl

    6. Changes in inflammation biomarker (stool - calprotectin) [6 weeks]

      Unit: mg/g

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Inflammatory bowel disease

    • Chronic pain (more than 3 months)

    • Pain (VAS > 3/10)

    Exclusion Criteria:

    • Contraindication to transcranial direct current stimulation

    • Contraindications to functional magnetic resonance imaging (fMRI)

    • Pregnancy

    • Sever internal or psychiatric condition

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charite University Medicine Berlin Germany 12200

    Sponsors and Collaborators

    • Charite University, Berlin, Germany
    • German Research Foundation

    Investigators

    • Principal Investigator: Magdalena S Prüß-Volz, MD, Charite University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Magdalena S. Prüß née Volz, Principal Investigator, MD, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT03825900
    Other Study ID Numbers:
    • EA4/221/17
    First Posted:
    Feb 1, 2019
    Last Update Posted:
    Sep 27, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Intestinal Diseases
    Inflammatory Bowel Diseases

    Study Results

    No Results Posted as of Sep 27, 2021