The RECLAIM Study. (RECLAIM)

March 26, 2026 updated by: Salvia BioElectronics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Broadmeadow, New South Wales, Australia, NSW, 2292
        • Active, not recruiting
        • Genesis Research Services
    • Queensland
      • Buderim, Queensland, Australia, 4556
        • Active, not recruiting
        • Resolve Pain
  • Belgium
    • Antwerpen
      • Wilrijk, Antwerpen, Belgium
        • Recruiting
        • ZAS Antwerpen, Campus Sint-Augustinus
        • Contact:
    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Recruiting
        • JESSA Hasselt
        • Contact:
    • Liège
      • Saint-Nicolas, Liège, Belgium
        • Active, not recruiting
        • Private Practice Dr. Sava
    • West Vlaanderen
      • Bruges, West Vlaanderen, Belgium, 8000
        • Recruiting
        • AZ Sint Jan Brugge
        • Contact:
        • Principal Investigator:
          • Dr. Van Dycke
        • Sub-Investigator:
          • Dr. Vandenbussche
      • Kortrijk, West Vlaanderen, Belgium
      • Ostend, West Vlaanderen, Belgium
      • Roeselare, West Vlaanderen, Belgium
        • Recruiting
        • AZ Delta
        • Contact:
  • Netherlands
      • Nieuwegein, Netherlands
        • Recruiting
        • St. Antonius Nieuwegein
        • Contact:
        • Principal Investigator:
          • Dr. Nijhuis
        • Sub-Investigator:
          • Dr. Hilkens
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus MC Rotterdam
        • Contact:
        • Principal Investigator:
          • Prof. Huygen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 - Treatment Group
Active therapy modality
Device: PRIMUS
The Salvia PRIMUS System is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves.
Other: Cohort 1 - Control Group
Sham therapy
Device: PRIMUS
The Salvia PRIMUS System is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves.
Experimental: Cohort 2 - Therapy V
Active therapy modality
Device: PRIMUS
The Salvia PRIMUS System is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves.
Experimental: Cohort 2 - Therapy D
Active therapy modality
Device: PRIMUS
The Salvia PRIMUS System is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Evaluation
Time Frame: 12 weeks
The incidence of serious procedure, device and/or stimulation-related adverse events.
12 weeks
Effectiveness Evaluation
Time Frame: 12 weeks
Proportion of subjects with ≥ 30% reduction in the number of Monthly Migraine Days (MMD), in randomized arms.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salvia BioElectronics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

June 4, 2024

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCI-03-RM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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