Transcranial Direct Current Stimulation and the Interaction Between Chronic Pain and the Intestinal Epithelial Barrier in Patients With Chronic Inflammatory Bowel Diseases (IBD)
- Conditions
- Inflammatory Bowel Diseases
- Interventions
- Device: Sham OR active Transcranial direct current stimulation
- Registration Number
- NCT03825900
- Lead Sponsor
- Charite University, Berlin, Germany
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 84
- Inflammatory bowel disease
- Chronic pain (more than 3 months)
- Pain (VAS > 3/10)
- Contraindication to transcranial direct current stimulation
- Contraindications to functional magnetic resonance imaging (fMRI)
- Pregnancy
- Sever internal or psychiatric condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham tDCS Sham OR active Transcranial direct current stimulation Sham transcranial direct current stimulation Active tDCS Sham OR active Transcranial direct current stimulation Active transcranial direct current stimulation
- Primary Outcome Measures
Name Time Method Functional changes in the brain measured with cerebral MRI 6 weeks Exploratory analyses of resting-state fMRI
Changes in perception of pain measured with an algometer (pain pressure threshold) 6 weeks continuous scale form 0 kg
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
- Secondary Outcome Measures
Name Time Method 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 inflammation biomarker (blood - C-reactive protein) 6 weeks unit: mg/dl
Changes in inflammation biomarker (stool - calprotectin) 6 weeks Unit: mg/g
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 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 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)
Trial Locations
- Locations (1)
Charite University Medicine
🇩🇪Berlin, Germany