Chronic MigraineSalviaBioNCT05858801
First Evaluation of a Craniofacial Nerve Stimulation System in Chronic Migraine
A study testing PRIMUS in people with Chronic Migraine, run by Salvia BioElectronics at 1 site in Belgium.
Trial summary
The purpose of this study is to demonstrate the safe use of the PRIMUS system in subjects with chronic migraine. This is a single-center, open label, prospective, early feasibility study to collect initial clinical data on the PRIMUS system for the treatment of chronic migraine. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- PRIMUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteBelgium
- Study dates
- 9 May 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Able and willing to provide informed consent
- Age ≥ 18 years and ≤ 84 years at time of consent
- Documented Chronic Migraine, defined as at least eight migraine days/month, for at least 1 year.
- Developed migraine before the age of 50
- Documented failure of 3 or more other preventive therapies (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated) from which at least 1 of the following 2: CGRP mAbs or Onabotulinumtoxin A
- Have at least 1 headache free day per month
- Stable on preventive migraine drugs and alternative treatment for at least three months prior to enrollment.
- Agree to refrain from starting new preventive migraine drugs or other preventive alternative migraine treatments, from 4 weeks before entering the baseline period throughout the duration of the study.
- MRI available (not older than 4 years prior to study enrollment) or willing to undergo an MRI to exclude structural lesions potentially causing headache
- Able and willing to complete a daily headache eDiary
Main Exclusion Criteria:
- Any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from migraine attacks, based on the quality of pain and associated symptoms.
- Concomitant neuromodulation
- Previous failure to an implantable neuromodulation device for neurovascular headache
- Have an existing Active Implantable Medical Device nearby the implant location (e.g. DBS, cochlear implant, …)
- Metal implants in the skull (e.g. skull plates, seeds) nearby the implant.
- Have a pacemaker of implantable cardioverter defibrillator (ICD)
- Current Opioid Use, defined as one or more opioids on more than 4 days/month for 3 consecutive months.
- Use of botulinum toxin injections in the past 3 months.
- Women of childbearing age who are pregnant, nursing or not using contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First Evaluation of a Craniofacial Peripheral Nerve Stimulation System in Chronic Migraine, an Early Feasibility Study
The purpose of this study is to demonstrate the safe use of the PRIMUS system in subjects with chronic migraine. This is a single-center, open label, prospective, early feasibility study to collect initial clinical data on the PRIMUS system for the treatment of chronic migraine.
- Conditions
- Chronic Migraine
- Being tested
- PRIMUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIMUSDevice
PRIMUS system
| Study group | Role | What they receive |
|---|---|---|
| PRIMUS | Experimental | PRIMUS system Receives: Device: PRIMUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation
The primary safety assessment is the incidence of serious procedure- and/or device-related adverse events in all subjects at 30 days and at the end of the study.
All adverse clinical events will be collected, coded, and reported, for the duration of the study according to the definitions of ISO 14155:2020.
Measured: 30 days
Safety Evaluation
The primary safety assessment is the incidence of serious procedure- and/or device-related adverse events in all subjects at 30 days and at the end of the study.
All adverse clinical events will be collected, coded, and reported, for the duration of the study according to the definitions of ISO 14155:2020.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start9 May 2023
- Primary completion9 Dec 2023
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salvia BioElectronics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858801
- Sponsor's protocol ID
- SCI-02-CM
- Acronym
- SalviaBio
- Status last verified
- Jul 2026
- First submitted
- 5 May 2023
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Evaluation of a Craniofacial Peripheral Nerve Stimulation System in Chronic Migraine, an Early Feasibility Study
- ClinicalTrials.gov ID
- NCT05858801
- Acronym / sponsor ID
- SalviaBio / SCI-02-CM
- Conditions
- Chronic Migraine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Salvia BioElectronicsIndustry (pharma, biotech, devices)
- Study start
- 9 May 2023 (actual)
- Primary completion
- 9 Dec 2023 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the safe use of the PRIMUS system in subjects with chronic migraine. This is a single-center, open label, prospective, early feasibility study to collect initial clinical data on the PRIMUS system for the treatment of chronic migraine.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRIMUS | Experimental | Device: PRIMUSPRIMUS system |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRIMUSPRIMUS system | Device | PRIMUS |
Primary outcome
Safety Evaluation
Time frame: 30 days
The primary safety assessment is the incidence of serious procedure- and/or device-related adverse events in all subjects at 30 days and at the end of the study. All adverse clinical events will be collected, coded, and reported, for the duration of the study according to the definitions of ISO 14155:2020.
Safety Evaluation
Time frame: 12 months
The primary safety assessment is the incidence of serious procedure- and/or device-related adverse events in all subjects at 30 days and at the end of the study. All adverse clinical events will be collected, coded, and reported, for the duration of the study according to the definitions of ISO 14155:2020.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRIMUS in people with Chronic Migraine, run by Salvia BioElectronics at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Evaluation (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.