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Clinical Trials/NCT02433470
NCT02433470
Completed
Phase 2

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

Charite University, Berlin, Germany1 site in 1 country20 target enrollmentApril 2015

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Inflammatory Bowel Disease
Sponsor
Charite University, Berlin, Germany
Enrollment
20
Locations
1
Primary Endpoint
Changes in perception of pain measured with visual analogue scale and pain pressure threshold
Status
Completed
Last Updated
8 years ago

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
December 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Magdalena S. Prüß née Volz

Dr. med. Magdalena Sarah Prüß (geb. Volz)

Charite University, Berlin, Germany

Eligibility Criteria

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

Outcomes

Primary Outcomes

Changes in perception of pain measured with visual analogue scale and pain pressure threshold

Time Frame: 2 weeks

Participants will be followed for 2 weeks

Functional and/or structural changes in the brain measured with cerebral MRI

Time Frame: 1 week

Participants will be followed for 2 weeks

Secondary Outcomes

  • Changes in activity indices (Harvey-Bradshaw Index (HBI) or simple clinical colitis activity index)(2 weeks)
  • Changes in quality of life(2 weeks)
  • Changes in pain catastophizing scale(2 weeks)
  • Changes in inflammation bBlood)(2 weeks)
  • Changes in functional symptoms (questionnaire: Irritable bowel syndrome - severity scoring system (IBS-SSS))(2 weeks)
  • Changes in inflammation (stool - calprotectin)(2 weeks)

Study Sites (1)

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