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Association Between Functional Changes in the Brain and the Perception of Pain in Patients With Inflammatory Bowel Diseases (IBD) - Measured With Functional Magnetic Resonance Imaging.

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Recruiting
CT.gov ID
NCT03348852
Collaborator
(none)
84
Enrollment
1
Location
2
Arms
71.2
Anticipated Duration (Months)
1.2
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 functional magnetic resonance imaging (fMRI) 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 fMRI.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial direct current stimulation
 Phase 2/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:
Assoziation Zwischen Funktionellen Gehirnveränderungen Und Der Schmerzwahrnehmung Bei Patienten Mit Chronisch entzündlicher Darmerkrankung Mittels fMRT
Actual Study Start Date :
Jan 24, 2017
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: Transcranial direct current stimulation
Device: Transcranial direct current stimulation Transcranial direct current stimulation over the motor cortex.
Other Names:
  • tDCS

    		•
    Sham Comparator: Sham tDCS

    Sham transcranial direct current stimulation

    Device: Transcranial direct current stimulation
    Device: Transcranial direct current stimulation Transcranial direct current stimulation over the motor cortex.
    Other Names:
  • tDCS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Functional and/or structural changes in the brain measured with cerebral MRI [2 week]

      Participants will be followed for 2 weeks

    2. Changes in pain measured with visual analogue scale [2 weeks]

      Participants will be followed for 2 weeks

    3. Changes in perception of pain measured with an algometer (pain pressure threshold) [2 weeks]

      Participants will be followed for 2 weeks

    Secondary Outcome Measures

    1. Changes in questionnaire "quality of life" [2 weeks]

      questionnaire

    2. Changes in functional symptoms [2 weeks]

      Questionnarie: irritable bowel syndrome - severity scoring system (IBS-SSS)

    3. Changes in activity indices [2 weeks]

      Harvey-Bradshaw Index (HBI) or simple clinical colitis activity index

    4. Changes in pain catastophizing scale [2 weeks]

    5. Changes in inflammation biomarker (blood - C-reactive protein) [2 weeks]

    6. Changes in inflammation biomarker (stool - calprotectin) [2 weeks]

    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 Charité University Medicine Berlin Germany 12200

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    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, Dr. med. Magdalena Sarah Prüß (geb. Volz), Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT03348852
    Other Study ID Numbers:
    • EA4/017/16
    First Posted:
    Nov 21, 2017
    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