Inflammatory Bowel Diseases
Conditions
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) and also with a change in permeability of the intestinal epithelial barrier 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. Additionally, transcranial direct current stimulation and the induced pain reduction influence the permeability of the intestinal epithelial barrier
Interventions
DEVICESham OR active Transcranial direct current stimulation
Sham OR active transcranial direct current stimulation over the motor cortex
Sponsors
German Research Foundation
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional changes in the brain measured with cerebral MRI | 6 weeks | Exploratory analyses of resting-state fMRI |
| Structural changes in the brain measured with cerebral MRI | 6 weeks | Exploratory analyses of MRI with respect to DTI (diffusions tensor imaging) and VBM (voxel based morphometry) |
| Functional and/or structural changes in the Intestinal Epithelial Barrier measured with endoscopy of the rectum with sample-taking | 6 weeks | — |
| Changes in pain measured with visual analogue scale | 6 weeks | VAS , scale from 0-10 |
| Changes in perception of pain measured with an algometer (pain pressure threshold) | 6 weeks | continuous scale form 0 kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in questionnaire quality of life | 6 weeks | questionnaire quality of life analyses daily activities, scale running from 32 points (worse outcome) to 224 points (best outcome) |
| Changes in inflammation biomarker (stool - calprotectin) | 6 weeks | Unit: mg/g |
| Changes in functional symptoms using IBS-SSS | 6 weeks | IBS-SSS: irritable bowel syndrome - severity score system , questionnaire analyses functional symptoms, score running from 0 (best outcome) until 600 points (worst outcome) |
| Changes in activity indices using HWI questionnaire or SCCAI questionnaire | 6 weeks | HWI: Harvey-Bradshaw-Index, SCCAI: Simple Clinical Colitis Activity Index, scale: points: 0-20 points (low points are best outcome, high points are worst outcome) |
| Changes in pain catastrophizing scale questionnaire | 6 weeks | pain catastrophizing scale questionnaire analyses subjective catastrophizing due to pain, score running from 0-52 points (low points are best outcome, high points are worst outcome) |
| Changes in inflammation biomarker (blood - C-reactive protein) | 6 weeks | unit: mg/dl |
Countries
Germany
Contacts
Primary ContactMagdalena S Prüß-Volz, MD
Outcome results
None listed