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.
Assoziation Zwischen Funktionellen Gehirnveränderungen Und Der Schmerzwahrnehmung Bei Patienten Mit Chronisch entzündlicher Darmerkrankung Mittels fMRT
1 other identifier
interventional
84
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2017
Longer than P75 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
January 24, 2017
CompletedFirst Submitted
Initial submission to the registry
May 22, 2017
CompletedFirst Posted
Study publicly available on registry
November 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedSeptember 27, 2021
September 1, 2021
5.9 years
May 22, 2017
September 24, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Functional and/or structural changes in the brain measured with cerebral MRI
Participants will be followed for 2 weeks
2 week
Changes in pain measured with visual analogue scale
Participants will be followed for 2 weeks
2 weeks
Changes in perception of pain measured with an algometer (pain pressure threshold)
Participants will be followed for 2 weeks
2 weeks
Secondary Outcomes (6)
Changes in questionnaire "quality of life"
2 weeks
Changes in functional symptoms
2 weeks
Changes in activity indices
2 weeks
Changes in pain catastophizing scale
2 weeks
Changes in inflammation biomarker (blood - C-reactive protein)
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
Device: Transcranial direct current stimulation 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 functional magnetic resonance imaging (fMRI)
- Pregnancy
- Sever internal or psychiatric condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charité 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
Central Study Contacts
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
May 22, 2017
First Posted
November 21, 2017
Study Start
January 24, 2017
Primary Completion
December 30, 2022
Study Completion
December 30, 2022
Last Updated
September 27, 2021
Record last verified: 2021-09