DRKS00009944
Completed
Phase 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 enrollmentFebruary 8, 2016
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Migraine
- Sponsor
- FE Klinische Funktionelle Neurobildgebung, Experimentelle Radiologie Radiologische Universitätsklinik Bonn
- Enrollment
- 44
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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