Assoziation Zwischen Funktionellen Gehirnveränderungen Und Der Schmerzwahrnehmung Bei Patienten Mit Chronisch entzündlicher Darmerkrankung Mittels fMRT
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Functional and/or structural changes in the brain measured with cerebral MRI
Study 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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Active tDCS
Active transcranial direct current stimulation
Intervention: Transcranial direct current stimulation (Device)
Sham tDCS
Sham transcranial direct current stimulation
Intervention: Transcranial direct current stimulation (Device)
Outcomes
Primary Outcomes
Functional and/or structural changes in the brain measured with cerebral MRI
Time Frame: 2 week
Participants will be followed for 2 weeks
Changes in pain measured with visual analogue scale
Time Frame: 2 weeks
Participants will be followed for 2 weeks
Changes in perception of pain measured with an algometer (pain pressure threshold)
Time Frame: 2 weeks
Participants will be followed for 2 weeks
Secondary Outcomes
- Changes in pain catastophizing scale(2 weeks)
- Changes in questionnaire "quality of life"(2 weeks)
- Changes in functional symptoms(2 weeks)
- Changes in activity indices(2 weeks)
- Changes in inflammation biomarker (blood - C-reactive protein)(2 weeks)
- Changes in inflammation biomarker (stool - calprotectin)(2 weeks)
Investigators
Magdalena S. Prüß née Volz
Dr. med. Magdalena Sarah Prüß (geb. Volz)
Charite University, Berlin, Germany