Prospective Analysis and Evaluation of freuquency and intensity of migraine, sleeping, Depression and Oxytocin and CGRP-Levels in patients with refractary migraine under noninvasive VNS stimulatio

Phase 3

• Conditions: R51; G43; Headache; Migraine

• Registration Number: DRKS00011089
• Lead Sponsor: Funktionelle Neurochirurgie, Stereotaxie und Neuromodulation, Klinik für Neurochirurgie, Universitätsklinikum Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-21
• Study Completion: 2016-11-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

male/femalen
- written informed consent
- stable headache medication history
- Refraktary
- Compliance to Follow-Up

Exclusion Criteria

-any Kind of historical neuological disease
- abuse of drugs
- severe psychological disorders
- Age below 18, above 60
-history of Neuromodulation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Analysis of Intensity and frequency of headache baseline and after 8 weeks of VNS <br>Stimulation with the MIDAS and the HIT6 scores<br><br>-Analysis of sleeping disturbances with the PSQI score baseline and after 8 weeks<br><br>-Analysis of Depression with the BDI score baseline and after 8 weeks<br><br>-Analysis of laboratory measurements of Oxytocin and CGRP baseline and after 8 weeks

Secondary Outcome Measures

Name	Time	Method
<br>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.