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

Transkranielle Gleichstromstimulation Und Die Interaktion Zwischen Chronischem Schmerz Und Der Intestinalen Epithelbarriere

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 Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Device: Sham OR active Transcranial direct current stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12200
    • Recruiting
    • Charité University Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active tDCS; Active transcranial direct current stimulation	Device: Sham OR active Transcranial direct current stimulation; Sham OR active transcranial direct current stimulation over the motor cortex; Other Names: Sham OR active tDCS
Sham Comparator: Sham tDCS; Sham transcranial direct current stimulation	Device: Sham OR active Transcranial direct current stimulation; Sham OR active transcranial direct current stimulation over the motor cortex; Other Names: Sham OR active tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional changes in the brain measured with cerebral MRI	Exploratory analyses of resting-state fMRI	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)	6 weeks
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	VAS , scale from 0-10	6 weeks
Changes in perception of pain measured with an algometer (pain pressure threshold)	continuous scale form 0 kg	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	6 weeks
Changes in inflammation biomarker (blood - C-reactive protein)	unit: mg/dl	6 weeks
Changes in inflammation biomarker (stool - calprotectin)	Unit: mg/g	6 weeks

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: German Research Foundation
• Investigators: Principal Investigator: Magdalena S Prüß-Volz, MD, Charité University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 24, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: EA4/221/17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No