Association of Functional Changes in the Brain and the Perception of Pain in Patients With Chronic Inflammatory Bowel Diseases (IBD)

Study Overview
=================
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) 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.

Conditions
-----------------
Inflammatory Bowel Disease

Intervention / Treatment
-----------------
* Device: Transcranial direct current stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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>* 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>* Transcranial direct current stimulation over the motor cortex<br>* 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 | Participants will be followed for 2 weeks | 1 week | 
| Changes in perception of pain measured with visual analogue scale and pain pressure threshold | Participants will be followed for 2 weeks | 2 weeks | 

Secondary Outcome Measures

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