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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03825900
• Other study ID #: EA4/221/17
• Status: Recruiting
• Phase: Phase 3
• Start date: June 1, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2021
• Source: Charite University, Berlin, Germany
• Contact: Magdalena S Prüß-Volz, MD
• Phone: +493084452718
• Email: magdalena.pruess[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Device:
• Sham OR active Transcranial direct current stimulation
Sham OR active transcranial direct current stimulation over the motor cortex

Locations

Country	Name	City	State
Germany	Charite University Medicine	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional changes in the brain measured with cerebral MRI	Exploratory analyses of resting-state fMRI	6 weeks
Primary	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
Primary	Functional and/or structural changes in the Intestinal Epithelial Barrier measured with endoscopy of the rectum with sample-taking		6 weeks
Primary	Changes in pain measured with visual analogue scale	VAS , scale from 0-10	6 weeks
Primary	Changes in perception of pain measured with an algometer (pain pressure threshold)	continuous scale form 0 kg	6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in inflammation biomarker (blood - C-reactive protein)	unit: mg/dl	6 weeks
Secondary	Changes in inflammation biomarker (stool - calprotectin)	Unit: mg/g	6 weeks