DRKS00003681
Completed
未知
Transcutaneous Vagus Nerve Stimulation for the treatment of chronic migraine - cMPsCMI01
cerbomed GmbH0 sites46 target enrollmentMarch 23, 2012
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- G43.3
- Sponsor
- cerbomed GmbH
- Enrollment
- 46
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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