Actively Recruiting
The RECLAIM Study.
Led by Salvia BioElectronics · Updated on 2026-03-27
110
Participants Needed
11
Research Sites
240 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
The RECLAIM Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
- Pregnant, nursing or not using contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Genesis Research Services
Broadmeadow, New South Wales, Australia, NSW, 2292
Active, Not Recruiting
2
Resolve Pain
Buderim, Queensland, Australia, 4556
Active, Not Recruiting
3
ZAS Antwerpen, Campus Sint-Augustinus
Wilrijk, Antwerpen, Belgium
Actively Recruiting
4
Jessa Hasselt
Hasselt, Limburg, Belgium, 3500
Actively Recruiting
5
Private Practice Dr. Sava
Saint-Nicolas, Liège, Belgium
Active, Not Recruiting
6
AZ Sint Jan Brugge
Bruges, West Vlaanderen, Belgium, 8000
Actively Recruiting
7
AZ Groeninge
Kortrijk, West Vlaanderen, Belgium
Actively Recruiting
8
AZ Oostende
Ostend, West Vlaanderen, Belgium
Actively Recruiting
9
AZ Delta
Roeselare, West Vlaanderen, Belgium
Actively Recruiting
10
St. Antonius Nieuwegein
Nieuwegein, Netherlands
Actively Recruiting
11
Erasmus MC Rotterdam
Rotterdam, Netherlands
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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