R51 G43
Conditions
Interventions
Group 1: ARM 1: This is a prospective pilotstudy of 14 patients to investigate the effectiveness of non-invaisve VNS-therapy (25Hz mit 5000Hz Burst) for patients suffering from refractory migraine wit
Sponsors
Funktionelle Neurochirurgie, Stereotaxie und Neuromodulation, Klinik für Neurochirurgie, Universitätsklinikum Bonn
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: - male/femalen - written informed consent - stable headache medication history - Refraktary - Compliance to Follow-Up
Exclusion criteria
Exclusion criteria: -any Kind of historical neuological disease - abuse of drugs - severe psychological disorders - Age below 18, above 60 -history of Neuromodulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Analysis of Intensity and frequency of headache baseline and after 8 weeks of VNS Stimulation with the MIDAS and the HIT6 scores -Analysis of sleeping disturbances with the PSQI score baseline and after 8 weeks -Analysis of Depression with the BDI score baseline and after 8 weeks -Analysis of laboratory measurements of Oxytocin and CGRP baseline and after 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of clinical outcome assessed by the above mentioned scores (MIDAS, HIT6, PSQI, BDI) and changes of oxytocin and CGRP Levels baseline and after 8 weeks of non-invasive VNS therapy. | — |
Countries
Germany
Contacts
Public ContactAzize Boström
Neurochirurgische Klinik,Universitätsklinikum Bonn
Outcome results
None listed