G43.3
Conditions
Interventions
Group 1: active group: transcutaneous, non-invasive electrical stimulation of the auricular branch of the vagus nerve by using a specific ear electrode. A cable connects this ear electrode with the st
Sponsors
cerbomed GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proof a the therapeutic efficacy of t-VNS for chronic migraine estimated via the number of headache days per 28 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactRuth Ruscheweyh
Oberbayerisches Kopfschmerzzentrum der LMU München
Outcome results
None listed