Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
62 participants
INTERVENTIONAL
2024-06-24
2028-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment Group
Active Stimulation
PRIMUS
The Salvia PRIMUS System is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves.
Control Group
Sham stimulation
PRIMUS
The Salvia PRIMUS System is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves.
Interventions
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PRIMUS
The Salvia PRIMUS System is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves.
Eligibility Criteria
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Inclusion Criteria
* Failure of 3 or more preventive pharmacological therapies
* Stable on preventive migraine treatments
* Psychologically stable
Exclusion Criteria
* 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 steroid infiltrations or IV administration in the past 3 months.
* Not pregnant, nursing or not using contraception
18 Years
84 Years
ALL
No
Sponsors
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Salvia BioElectronics
INDUSTRY
Responsible Party
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Locations
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Genesis Research Services
Broadmeadow, New South Wales, Australia
Resolve Pain
Buderim, Queensland, Australia
Jessa Hasselt
Hasselt, Limburg, Belgium
AZ Sint Jan Brugge
Bruges, West Vlaanderen, Belgium
AZ Delta
Roeselare, , Belgium
ZAS Antwerpen, Campus Sint-Augustinus
Wilrijk, , Belgium
St. Antonius Nieuwegein
Nieuwegein, , Netherlands
Erasmus MC Rotterdam
Rotterdam, , Netherlands
Countries
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Facility Contacts
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Plazier, Prof. Dr.
Role: primary
Study Coordinator
Role: primary
Billet, Dr.
Role: primary
Kelderman, Dr.
Role: primary
Study Coordinator
Role: primary
Dr. Siepman
Role: primary
Other Identifiers
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SCI-03-RM
Identifier Type: -
Identifier Source: org_study_id