RecruitingNot ApplicableNCT06450444

The RECLAIM Study.

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

Sponsor

Salvia BioElectronics

Enrollment

110 participants

Start Date

Jun 24, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Migraine High Frequency Episodic Migraine

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.

Eligibility

Min Age: 18 YearsMax Age: 84 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called PRIMUS for people with chronic migraine and high frequency episodic migraine. The study is currently recruiting participants at 11 locations. People eligible for this study include aged 18 Years to 84 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPRIMUS

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

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NCT06450444

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