Transcranial Direct Current Stimulation and the Interaction Between Chronic Pain and the Intestinal Epithelial Barrier in Patients With Chronic Inflammatory Bowel Diseases (IBD)

Charite University, Berlin, Germany84 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Inflammatory Bowel Diseases

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Functional changes in the brain measured with cerebral MRI

Exploratory analyses of resting-state fMRI

Time frame: 6 weeks

Structural changes in the brain measured with cerebral MRI

Exploratory analyses of MRI with respect to DTI (diffusions tensor imaging) and VBM (voxel based morphometry)

Time frame: 6 weeks

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

VAS , scale from 0-10

Time frame: 6 weeks

Changes in perception of pain measured with an algometer (pain pressure threshold)

continuous scale form 0 kg

Time frame: 6 weeks

Secondary Outcomes

Changes in questionnaire "quality of life"

questionnaire "quality of life" analyses daily activities, scale running from 32 points (worse outcome) to 224 points (best outcome)

Time frame: 6 weeks

Changes in functional symptoms using IBS-SSS

IBS-SSS: irritable bowel syndrome - severity score system , questionnaire analyses functional symptoms, score running from 0 (best outcome) until 600 points (worst outcome)

Time frame: 6 weeks

Changes in activity indices using HWI questionnaire or SCCAI questionnaire

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)

Time frame: 6 weeks

Changes in pain catastrophizing scale questionnaire

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)

Time frame: 6 weeks

Changes in inflammation biomarker (blood - C-reactive protein)

unit: mg/dl

Time frame: 6 weeks

Changes in inflammation biomarker (stool - calprotectin)

Unit: mg/g

Time frame: 6 weeks

Transcranial Direct Current Stimulation and the Interaction Between Chronic Pain and the Intestinal Epithelial Barrier in Patients With Chronic Inflammatory Bowel Diseases (IBD)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts