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.

Study Overview
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Brief Summary
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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.

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

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Device: Transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active tDCS<br>Active transcranial direct current stimulation | Device: Transcranial direct current stimulation<br>* Device: Transcranial direct current stimulation Transcranial direct current stimulation over the motor cortex.<br>* Other names: tDCS;|
| Sham Comparator: Sham tDCS<br>Sham transcranial direct current stimulation | Device: Transcranial direct current stimulation<br>* Device: Transcranial direct current stimulation Transcranial direct current stimulation over the motor cortex.<br>* Other names: tDCS;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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