Association of Functional Changes in the Brain and the Perception of Pain in Patients With Chronic Inflammatory Bowel Diseases (IBD)
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 25, 2015
CompletedFirst Posted
Study publicly available on registry
May 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedJanuary 24, 2018
January 1, 2018
1.7 years
April 25, 2015
January 23, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Functional and/or structural changes in the brain measured with cerebral MRI
Participants will be followed for 2 weeks
1 week
Changes in perception of pain measured with visual analogue scale and pain pressure threshold
Participants will be followed for 2 weeks
2 weeks
Secondary Outcomes (6)
Changes in quality of life
2 weeks
Changes in functional symptoms (questionnaire: Irritable bowel syndrome - severity scoring system (IBS-SSS))
2 weeks
Changes in activity indices (Harvey-Bradshaw Index (HBI) or simple clinical colitis activity index)
2 weeks
Changes in pain catastophizing scale
2 weeks
Changes in inflammation bBlood)
2 weeks
- +1 more secondary outcomes
Study Arms (2)
Active tDCS
ACTIVE COMPARATORActive transcranial direct current stimulation
Sham tDCS
SHAM COMPARATORSham transcranial direct current stimulation
Interventions
Transcranial direct current stimulation over the motor cortex
Eligibility Criteria
You may qualify if:
- Inflammatory bowel disease
- Chronic pain (more than 3 months)
- Pain (VAS \> 3/10)
You may not qualify if:
- Contraindication to transcranial direct current stimulation
- Contraindications to magnetic resonance imaging (MRI)
- Pregnancy
- Sever internal or psychiatric condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charite University Medicine
Berlin, 12200, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magdalena S Prüß-Volz, MD
Charite University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med. Magdalena Sarah Prüß (geb. Volz)
Study Record Dates
First Submitted
April 25, 2015
First Posted
May 5, 2015
Study Start
April 1, 2015
Primary Completion
December 1, 2016
Last Updated
January 24, 2018
Record last verified: 2018-01