- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02433470
Association of Functional Changes in the Brain and the Perception of Pain in Patients With Chronic Inflammatory Bowel Diseases (IBD)
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) 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Berlin, Germany, 12200
- Charité University Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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 magnetic resonance imaging (MRI)
- Pregnancy
- Sever internal or psychiatric condition
Study Plan
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
|
Transcranial direct current stimulation over the motor cortex
Other Names:
|
Sham Comparator: Sham tDCS
Sham transcranial direct current stimulation
|
Transcranial direct current stimulation over the motor cortex
Other Names:
|
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: 1 week
|
Participants will be followed for 2 weeks
|
1 week
|
Changes in perception of pain measured with visual analogue scale and 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 pain catastophizing scale
Time Frame: 2 weeks
|
2 weeks
|
|
Changes in quality of life
Time Frame: 2 weeks
|
2 weeks
|
|
Changes in functional symptoms (questionnaire: Irritable bowel syndrome - severity scoring system (IBS-SSS))
Time Frame: 2 weeks
|
Questionnaire: irritable bowel syndrome - severity scoring system (IBS-SSS)
|
2 weeks
|
Changes in activity indices (Harvey-Bradshaw Index (HBI) or simple clinical colitis activity index)
Time Frame: 2 weeks
|
(Harvey-Bradshaw Index (HBI) or simple clinical colitis activity index)
|
2 weeks
|
Changes in inflammation bBlood)
Time Frame: 2 weeks
|
2 weeks
|
|
Changes in inflammation (stool - calprotectin)
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Magdalena S Prüß-Volz, MD, Charité University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA4/028/15
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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