Assessment of non-invasive vagal nerve Stimulation (VNS)-induced head pain-effects in refractory migraine patients: a multimodal fMRI study

Phase 3

• Conditions: Migraine; R51; G43; Headache

• Registration Number: DRKS00009944
• Lead Sponsor: FE Klinische Funktionelle Neurobildgebung, Experimentelle Radiologie Radiologische Universitätsklinik Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-08
• Study Completion: 2018-01-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: interventional
• Study Design: Not specified