RECRUITINGINTERVENTIONAL
The RECLAIM Study.
Randomized, Double-blind, Controlled Trial to Investigate Combined Occipital and Supra-orbital Neuromodulation in Resistant Migraine. The RECLAIM Study.
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
PRIMUS
The Salvia PRIMUS System is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves.
Locations (11)
Genesis Research Services
Broadmeadow, New South Wales, Australia
Resolve Pain
Buderim, Queensland, Australia
ZAS Antwerpen, Campus Sint-Augustinus
Wilrijk, Antwerpen, Belgium
Jessa Hasselt
Hasselt, Limburg, Belgium
Private Practice Dr. Sava
Saint-Nicolas, Liège, Belgium
AZ Sint Jan Brugge
Bruges, West Vlaanderen, Belgium
AZ Groeninge
Kortrijk, West Vlaanderen, Belgium
AZ Oostende
Ostend, West Vlaanderen, Belgium
AZ Delta
Roeselare, West Vlaanderen, Belgium
St. Antonius Nieuwegein
Nieuwegein, Netherlands
Erasmus MC Rotterdam
Rotterdam, Netherlands