Transkranielle Gleichstromstimulation Und Die Interaktion Zwischen Chronischem Schmerz Und Der Intestinalen Epithelbarriere
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Functional changes in the brain measured with cerebral MRI
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) 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Active tDCS
Active transcranial direct current stimulation
Intervention: Sham OR active Transcranial direct current stimulation (Device)
Sham tDCS
Sham transcranial direct current stimulation
Intervention: Sham OR active Transcranial direct current stimulation (Device)
Outcomes
Primary Outcomes
Functional changes in the brain measured with cerebral MRI
Time Frame: 6 weeks
Exploratory analyses of resting-state fMRI
Changes in perception of pain measured with an algometer (pain pressure threshold)
Time Frame: 6 weeks
continuous scale form 0 kg
Structural changes in the brain measured with cerebral MRI
Time Frame: 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
Time Frame: 6 weeks
Changes in pain measured with visual analogue scale
Time Frame: 6 weeks
VAS , scale from 0-10
Secondary Outcomes
- Changes in pain catastrophizing scale questionnaire(6 weeks)
- Changes in functional symptoms using IBS-SSS(6 weeks)
- Changes in inflammation biomarker (blood - C-reactive protein)(6 weeks)
- Changes in inflammation biomarker (stool - calprotectin)(6 weeks)
- Changes in questionnaire "quality of life"(6 weeks)
- Changes in activity indices using HWI questionnaire or SCCAI questionnaire(6 weeks)
Investigators
Magdalena S. Prüß née Volz
Principal Investigator, MD
Charite University, Berlin, Germany