Chronic Migraine, High Frequency Episodic Migraine
Conditions
Brief summary
The purpose of this study is to evaluate the safety and performance, including clinical benefit, of the PRIMUS System for the treatment of Resistant Migraine.
Interventions
DEVICEPRIMUS
The Salvia PRIMUS System is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves.
Sponsors
Salvia BioElectronics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of migraine as defined by the ICHD-3 Classification (with or without aura) with a history of chronic or high-frequency episodic migraine for at least 1 year prior to screening * Failure of 3 or more preventive pharmacological therapies * Stable on preventive migraine treatments * Psychologically stable
Exclusion criteria
* Concomitant invasive or non-invasive neuromodulation * Previous exposure to an implantable neuromodulation device for headache * Have an existing active implantable medical device nearby the implant location (e.g. DBS, cochlear implant) * Use of onabotulinum toxin A injections for the treatment of migraine in the past 3 months. * Use of local corticosteroid injections in the occipital or supra-orbital region in the past 3 months prior to enrollment. * Not pregnant, nursing or not using contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Evaluation | 12 weeks | The incidence of serious procedure, device and/or stimulation-related adverse events. |
| Effectiveness Evaluation | 12 weeks | Proportion of subjects with ≥ 30% reduction in the number of Monthly Migraine Days (MMD), in randomized arms. |
Countries
Australia, Belgium, Netherlands
Outcome results
None listed