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← Trials
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The RECLAIM Study.

RecruitingNAAges 18 Years - 84 YearsAllSalvia BioElectronics
NCT06450444 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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
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What it tests

  • PRIMUS
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Where

11 sites
Genesis Research Services
Broadmeadow, Australia
Resolve Pain
Buderim, Australia
ZAS Antwerpen, Campus Sint-Augustinus
Wilrijk, Belgium
Jessa Hasselt
Hasselt, Belgium
Private Practice Dr. Sava
Saint-Nicolas, Belgium
AZ Sint Jan Brugge
Bruges, Belgium
AZ Groeninge
Kortrijk, Belgium
AZ Oostende
Ostend, Belgium

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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