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.

September 24, 2021 updated by: Magdalena S. Prüß née Volz, Charite University, Berlin, Germany

Assoziation Zwischen Funktionellen Gehirnveränderungen Und Der Schmerzwahrnehmung Bei Patienten Mit Chronisch entzündlicher Darmerkrankung Mittels fMRT

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Recruiting
        • Charite University Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional and/or structural changes in the brain measured with cerebral MRI
Time Frame: 2 week
Participants will be followed for 2 weeks
2 week
Changes in pain measured with visual analogue scale
Time Frame: 2 weeks
Participants will be followed for 2 weeks
2 weeks
Changes in perception of pain measured with an algometer (pain pressure threshold)
Time Frame: 2 weeks
Participants will be followed for 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in questionnaire "quality of life"
Time Frame: 2 weeks
questionnaire
2 weeks
Changes in functional symptoms
Time Frame: 2 weeks
Questionnarie: irritable bowel syndrome - severity scoring system (IBS-SSS)
2 weeks
Changes in activity indices
Time Frame: 2 weeks
Harvey-Bradshaw Index (HBI) or simple clinical colitis activity index
2 weeks
Changes in pain catastophizing scale
Time Frame: 2 weeks
2 weeks
Changes in inflammation biomarker (blood - C-reactive protein)
Time Frame: 2 weeks
2 weeks
Changes in inflammation biomarker (stool - calprotectin)
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2017

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

May 22, 2017

First Submitted That Met QC Criteria

November 16, 2017

First Posted (Actual)

November 21, 2017

Study Record Updates

Last Update Posted (Actual)

September 27, 2021

Last Update Submitted That Met QC Criteria

September 24, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA4/017/16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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