DRKS00009944CompletedPhase 3
Assessment of non-invasive vagal nerve Stimulation (VNS)-induced head pain-effects in refractory migraine patients: a multimodal fMRI study - nVNS fMRT refractory migraine
FE Klinische Funktionelle Neurobildgebung, Experimentelle Radiologie Radiologische Universitätsklinik Bonn0 sites44 target enrollmentStarted: February 8, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 44
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 20 Years to 60 Years (—)
- Sex
- All
Inclusion Criteria
- •Male / Female subjects
- •- Right-handedness
- •- Oral and written informed consent
- •- Stable headache medication 4 weeks prior to study entry
- •- Refractory to drug / behavior therapy / psychiatric therapies
- •-confirmed diagnosis according to IHCD-3 beta
- •-Willing to fullfil follow-up investigations
Exclusion Criteria
- •- Neurological diseases, current and / or history (including severe craniocerebral trauma.)
- •- Abuse or dependence of analgesic / psychotropic substances including alcohol (except nicotine) in the history or current
- •- Severe psychiatric disorders in history and currently, serious physical disorders, especially unstable cardiovascular disorders
- •- Claustrophobia
- •- Non-removable ferromagnetic metallic implants, probes, stimulators, prostheses, pacemakers, large tattoos, etc.
- •- Age <25 or> 60 years
- •- Neuromodulation treatment in prehistory
Investigators
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