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.

Inflammatory Bowel Diseases Clinical Trial

Official title:

Assoziation Zwischen Funktionellen Gehirnveränderungen Und Der Schmerzwahrnehmung Bei Patienten Mit Chronisch entzündlicher Darmerkrankung Mittels fMRT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03348852
• Other study ID #: EA4/017/16
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 24, 2017
• 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 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.

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:
• Transcranial direct current stimulation
Device: Transcranial direct current stimulation Transcranial direct current stimulation over the motor cortex.

Locations

Country	Name	City	State
Germany	Charité University Medicine	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional and/or structural changes in the brain measured with cerebral MRI	Participants will be followed for 2 weeks	2 week
Primary	Changes in pain measured with visual analogue scale	Participants will be followed for 2 weeks	2 weeks
Primary	Changes in perception of pain measured with an algometer (pain pressure threshold)	Participants will be followed for 2 weeks	2 weeks
Secondary	Changes in questionnaire "quality of life"	questionnaire	2 weeks
Secondary	Changes in functional symptoms	Questionnarie: irritable bowel syndrome - severity scoring system (IBS-SSS)	2 weeks
Secondary	Changes in activity indices	Harvey-Bradshaw Index (HBI) or simple clinical colitis activity index	2 weeks
Secondary	Changes in pain catastophizing scale		2 weeks
Secondary	Changes in inflammation biomarker (blood - C-reactive protein)		2 weeks
Secondary	Changes in inflammation biomarker (stool - calprotectin)		2 weeks