The RECLAIM Study.

Recruiting now · Not applicable

Conditions studied: Chronic Migraine, High Frequency Episodic Migraine

In brief

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.

Key facts

Study ID

NCT06450444

Run by

Salvia BioElectronics

People needed

110

Starts

2024-06-24

Expected to finish

2029-01-31

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Erasmus MC Rotterdam — Rotterdam, Netherlands (enrolling)
• AZ Oostende — Ostend, West Vlaanderen, Belgium (enrolling)
• AZ Delta — Roeselare, West Vlaanderen, Belgium (enrolling)
• St. Antonius Nieuwegein — Nieuwegein, Netherlands (enrolling)
• ZAS Antwerpen, Campus Sint-Augustinus — Wilrijk, Antwerpen, Belgium (enrolling)
• Jessa Hasselt — Hasselt, Limburg, Belgium (enrolling)
• AZ Sint Jan Brugge — Bruges, West Vlaanderen, Belgium (enrolling)
• AZ Groeninge — Kortrijk, West Vlaanderen, Belgium (enrolling)
• Resolve Pain — Buderim, Queensland, Australia
• Private Practice Dr. Sava — Saint-Nicolas, Liège, Belgium
• Genesis Research Services — Broadmeadow, New South Wales, Australia

Full record on ClinicalTrials.gov

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