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NCT02433470 Clinical Trial

Association of Functional Changes in the Brain and the Perception of Pain in Patients With Chronic Inflammatory Bowel Diseases (IBD)

Inflammatory Bowel Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02433470
Other study ID # EA4/028/15
Secondary ID
Status Completed
Phase Phase 2
First received April 25, 2015
Last updated January 23, 2018
Start date April 2015

Study information
Verified date January 2018
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
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) 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
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 magnetic resonance imaging (MRI)

- Pregnancy

- Sever internal or psychiatric condition

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany Charite 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 1 week
Primary Changes in perception of pain measured with visual analogue scale and pain pressure threshold Participants will be followed for 2 weeks 2 weeks
Secondary Changes in quality of life 2 weeks
Secondary Changes in functional symptoms (questionnaire: Irritable bowel syndrome - severity scoring system (IBS-SSS)) Questionnaire: 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) (Harvey-Bradshaw Index (HBI) or simple clinical colitis activity index) 2 weeks
Secondary Changes in pain catastophizing scale 2 weeks
Secondary Changes in inflammation bBlood) 2 weeks
Secondary Changes in inflammation (stool - calprotectin) 2 weeks
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