The RECLAIM Study.
Recruiting · NCT06450444 · Interventional (participants receive a specific treatment) · Lead sponsor: Salvia BioElectronics
View the official record on ClinicalTrials.gov →Interventions studied
PRIMUS
What this trial is about
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 can take part
Age range
18 Years to 84 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
11 locations listed.
- St. Antonius Nieuwegein - Nieuwegein, Netherlands
- Erasmus MC Rotterdam - Rotterdam, Netherlands
- ZAS Antwerpen, Campus Sint-Augustinus - Wilrijk, Antwerpen, Belgium
- Jessa Hasselt - Hasselt, Limburg, Belgium
- Private Practice Dr. Sava - Saint-Nicolas, Liège, Belgium
- Genesis Research Services - Broadmeadow, New South Wales, Australia
- Resolve Pain - Buderim, Queensland, Australia
- 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