Association Between Functional Changes in the Brain and the Perception of Pain in Patients With Inflammatory Bowel Diseases (IBD) - Measured With Functional Magnetic Resonance Imaging.

Phase 2

• Conditions: Inflammatory Bowel Diseases
• Interventions: Device: Transcranial direct current stimulation

• Registration Number: NCT03348852
• 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 functional magnetic resonance imaging (fMRI) 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 fMRI.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-24
• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-11-16
• Study First Posted: 2017-11-21
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-24
• Last Update Posted: 2021-09-27
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tDCS	Transcranial direct current stimulation	Sham transcranial direct current stimulation
Active tDCS	Transcranial direct current stimulation	Active transcranial direct current stimulation

Primary Outcome Measures

Name	Time	Method
Functional and/or structural changes in the brain measured with cerebral MRI	2 week	Participants will be followed for 2 weeks
Changes in pain measured with visual analogue scale	2 weeks	Participants will be followed for 2 weeks
Changes in perception of pain measured with an algometer (pain pressure threshold)	2 weeks	Participants will be followed for 2 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in pain catastophizing scale	2 weeks
Changes in questionnaire "quality of life"	2 weeks	questionnaire
Changes in functional symptoms	2 weeks	Questionnarie: irritable bowel syndrome - severity scoring system (IBS-SSS)
Changes in activity indices	2 weeks	Harvey-Bradshaw Index (HBI) or simple clinical colitis activity index
Changes in inflammation biomarker (blood - C-reactive protein)	2 weeks
Changes in inflammation biomarker (stool - calprotectin)	2 weeks

Trial Locations

Locations (1)

Charité University Medicine; 🇩🇪 Berlin, Germany