NCT06450444Recruiting
The RECLAIM Study.
Randomized, Double-blind, Controlled Trial to Investigate Combined Occipital and Supra-orbital Neuromodulation in Resistant Migraine. The RECLAIM Study.
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 4 Jun 2024
- Start date
- 24 Jun 2024
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Salvia BioElectronics
- Diseases
- Migraine
- NCT number
- NCT06450444
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 24 Jun 2024 to the primary completion date, 1 Apr 2027
- 11 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Use of onabotulinum toxin A injections for the treatment of migraine in the past 3 months.
- Not pregnant, nursing or not using contraception
Who the study is looking for
- 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
Age in the registry: 18 years to 84 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Genesis Research Services Coordinator of this site? Confirm its status | Broadmeadow | Australia | Terminated |
| Resolve Pain Coordinator of this site? Confirm its status | Buderim | Australia | Terminated |
| Az Sint Jan Brugge Coordinator of this site? Confirm its status | Bruges | Belgium | Recruiting |
| JESSA Hasselt Coordinator of this site? Confirm its status | Hasselt | Belgium | Recruiting |
| AZ Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Recruiting |
| AZ Oostende Coordinator of this site? Confirm its status | Ostend | Belgium | Recruiting |
| AZ Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Recruiting |
| Private Practice Dr. Sava Coordinator of this site? Confirm its status | Saint-Nicolas | Belgium | Active, not recruiting |
| ZAS Antwerpen, Campus Sint-Augustinus Coordinator of this site? Confirm its status | Wilrijk | Belgium | Recruiting |
| St. Antonius Nieuwegein Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Recruiting |
| Erasmus MC Rotterdam Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.