Recruiting NCT06450444
The RECLAIM Study.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PRIMUS.
- Who it may be relevant to
- Registry conditions: Chronic Migraine, High Frequency Episodic Migraine. Basic parameters: 18 years — 84 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, Belgium, Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized, Double-blind, Controlled Trial to Investigate Combined Occipital and Supra-orbital Neuromodulation in Resistant Migraine. The RECLAIM Study.
Overview
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.
Interventions
- Device PRIMUS
The Salvia PRIMUS System is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves.
Primary outcome measures
- Safety Evaluation [Time frame: 12 weeks]
- Effectiveness Evaluation [Time frame: 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Belgium · 7 centers
- ZAS Antwerpen, Campus Sint-Augustinus — Wilrijk
- Jessa Hasselt — Hasselt
- Private Practice Dr. Sava — Saint-Nicolas
- AZ Sint Jan Brugge — Bruges
- AZ Groeninge — Kortrijk
- AZ Oostende — Ostend
- AZ Delta — Roeselare
Australia · 2 centers
- Genesis Research Services — Broadmeadow
- Resolve Pain — Buderim
Netherlands · 2 centers
- St. Antonius Nieuwegein — Nieuwegein
- Erasmus MC Rotterdam — Rotterdam
Identifiers
NCT: NCT06450444 · SCI-03-RM