Transcutaneous Vagus Nerve Stimulation for the treatment of chronic migraine

Not Applicable

• Conditions: G43.3; Complicated migraine

• Registration Number: DRKS00003681
• Lead Sponsor: cerbomed GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-23
• Study Completion: 2014-11-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

males and females from 18 to 70 y. Patients suffering from chronic migraine according to ICHD-II 1.5.1. Duration of disease of minimum 3 months. Prophylactic medication on a stable regimen for minimum 1 month or 5 half-lives (the longer duration will be counted). Stable agent(s) for acute medication during baseline period. Patient diary kept properly for minimum 20 out of 28 days, minimum 15 headache days with minimum 4 hours of headache, extrapolation to 28 days.

Exclusion Criteria

Participation in another clinical trial during the last 4 weeks before study entry. Pregnant or breastfeeding women. Suffering from craniomandibular dysfunction or fibromyalgia. Other primary/secondary headache disorders (e.g. cluster headache, trigeminal neuralgia, etc.). Beck depression inventory > 24 at date of inclusion. Other chronic neurological or psychiatric disorders (e.g. psychoses) which impair study participation. Dependance on opioids or benzodiazepines. Anatomical or pathological abnormalities at the left ear. Actual process of retirement.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proof a the therapeutic efficacy of t-VNS for chronic migraine estimated via the number of headache days per 28 days.

Secondary Outcome Measures

Name	Time	Method
Recording of the headache related burden. Recording of the amount of acute medication needed. Recording of the headache intensity. Recording of any adverse events of t-VNS. estimated via: headache intensity during headache days. Consumption of acute medication. Number of migraine related consultations. MIDAS. HIT-6-Score. Mode and number of AEs and SAEs.