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Tests the PRIMUS device for migraine that has not responded to other treatments

Tests the PRIMUS device in adults with chronic or frequent migraine.

Key facts

Who runs it
Salvia BioElectronics
Where
Broadmeadow and Buderim, AustraliaSee the 2 sitesAlso in 2 other countries, 9 sites
Trial code
Registry title
The RECLAIM Study.
Status
Recruiting
People taking part
110 people, planned
Started
24 Jun 2024
Expected to end
31 Jan 2029
Type of study
Interventional, 4 groups
Treatments tested
  • PRIMUS
Record updated
6 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with migraine that has not improved with several preventive medicines. It tests a device called the PRIMUS System.

Age
18 to 84 years
Sex
All sexes can join.
Disease stage
Chronic migraine or high-frequency episodic migraine, with or without aura, for at least 1 year before screening.
Earlier treatment
Must have failed 3 or more preventive medicines and be stable on current preventive migraine treatment. Cannot have had onabotulinum toxin A injections for migraine or local corticosteroid injections in the occipital or supra-orbital region in the past 3 months.

Main reasons for not taking part

  • Other invasive or non-invasive neuromodulation at the same time
  • Earlier use of an implanted neuromodulation device for headache
  • An active implanted medical device near the implant site, such as DBS or a cochlear implant
  • Onabotulinum toxin A injections for migraine in the past 3 months
  • Local corticosteroid injections in the occipital or supra-orbital region in the past 3 months

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 local corticosteroid injections in the occipital or supra-orbital region in the past 3 months prior to enrollment
  • Use of onabotulinum toxin A injections for the treatment of migraine in the past 3 months
  • Not pregnant, nursing or not using contraception

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 84 years old?

Where in Australia

Also in 2 other countries, 9 sites

  • Genesis Research ServicesBroadmeadow, AustraliaNo longer taking part
  • Resolve PainBuderim, AustraliaNo longer taking part

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • Cohort 1 - Treatment GroupTreatment being tested

    Active therapy modality

    Treatment: PRIMUS

  • Cohort 1 - Control GroupOther group

    Sham therapy

    Treatment: PRIMUS

  • Cohort 2 - Therapy VTreatment being tested

    Active therapy modality

    Treatment: PRIMUS

  • Cohort 2 - Therapy DTreatment being tested

    Active therapy modality

    Treatment: PRIMUS

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Randomized, Double-blind, Controlled Trial to Investigate Combined Occipital and Supra-orbital Neuromodulation in Resistant Migraine. The RECLAIM Study.
Plain-language title
Tests the PRIMUS device for migraine that has not responded to other treatmentsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06450444, who can take part
Record updated
6 August 2026