Tests the PRIMUS device for migraine that has not responded to other treatments
Tests the PRIMUS device in adults with chronic or frequent migraine.
Plain-language title generated from the registry record
Registry title: The RECLAIM Study.
Key facts
- Where
- Broadmeadow and Buderim, AustraliaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 84 years old?
Source: NCT06450444, who can take part
Where in Australia
- Genesis Research ServicesBroadmeadow, AustraliaNo longer taking part
- Resolve PainBuderim, AustraliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Salvia BioElectronics
- Trial code
- NCT06450444
- Record updated
- 6 August 2026
- Original description
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.Read full original descriptionShow less
Randomized, Double-blind, Controlled Trial to Investigate Combined Occipital and Supra-orbital Neuromodulation in Resistant Migraine. The RECLAIM Study.
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.
Inclusion: 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: 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 local corticosteroid injections in the occipital or supra-orbital region in the past 3 months prior to enrollment; Use of onabotulinum toxin A injections for the treatment of migraine in the past 3 months; Not pregnant, nursing or not using contraception.