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RECRUITING
NCT06450444
NA

The RECLAIM Study.

Sponsor: Salvia BioElectronics

View on ClinicalTrials.gov

Summary

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.

Official title: Randomized, Double-blind, Controlled Trial to Investigate Combined Occipital and Supra-orbital Neuromodulation in Resistant Migraine. The RECLAIM Study.

Key Details

Gender

All

Age Range

18 Years - 84 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2024-06-24

Completion Date

2029-01-31

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

DEVICE

PRIMUS

The Salvia PRIMUS System is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves.

Locations (11)

Genesis Research Services

Broadmeadow, New South Wales, Australia

Resolve Pain

Buderim, Queensland, Australia

ZAS Antwerpen, Campus Sint-Augustinus

Wilrijk, Antwerpen, Belgium

Jessa Hasselt

Hasselt, Limburg, Belgium

Private Practice Dr. Sava

Saint-Nicolas, Liège, Belgium

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

St. Antonius Nieuwegein

Nieuwegein, Netherlands

Erasmus MC Rotterdam

Rotterdam, Netherlands