Headache Migraine ChronicNCT06167655
A PIVOTAL STUDY EVALUATING SAFETY AND EFFICACY OF THE SHIRATRONICS MIGRAINE THERAPY SYSTEM
A study testing Neurostimulator in people with Headache Migraine Chronic, run by ShiraTronics at 23 sites in 2 countries.
Trial summary
Prospective, multi-center, double blind, randomized, sham-controlled study to evaluate neuromodulation in patient with chronic migraine. The study hypothesis to be tested is the mean reduction in mean monthly headache days between patients in treatment versus sham. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Headache Migraine Chronic
- What is being tested?
- Neurostimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 29 May 2024to May 2031
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 22 years of age.
- Have migraine onset at ≤ 50 years of age.
- Have a history of migraine for ≥ 12 months prior to screening.
- Have 15 - 26 headache days/month, among which ≥ 8 days has the features of probable migraine, and minimum of 2 headache-free days/month during the 28-day screening period.
- Fulfill the criteria for chronic migraine (CM) during the 28-day screening period.
- Have a diagnosis of refractory chronic migraine (RCM), who have inadequate response or no access to, or are intolerant, unwilling, or contraindicated to Onabotulinum toxin A (Botox) therapy, and One of the medications that belong to Calcitonin Gene Related Peptide Monoclonal antibodies (CGRP) therapy or CGRP antagonist therapy.
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- Maintain a stable use of preventive(s) migraine medication for ≥ 3 months before screening. Subjects receiving OnabotunlinumtoxinA must stop therapy ≥ 3 months prior to screening visit.
- Demonstrate ≥ 80% compliance with the headache diary during the screening period by entering headache data on a minimum of 22 out of 28 days.
- Be willing and able to comply with all study procedures and return to the clinic for the follow-up evaluation, as specified in this protocol.
- Be able to give voluntary, written informed consent to participate in this study.
Who cannot join
- Type of headache or migraine other than RCM including the following:
- Post-traumatic headache (e.g., battlefield, accidents, etc.).
- Regular intake of opioids (including codeine) of ≥ 8 days in the past 3 months and during the 28-day screening/baseline phase and cannot be accounted for by another diagnosis.
- Regular intake of Barbiturates for ≥ 5 days/month in the past 3 months and during the 28-day screening/baseline phase and cannot be accounted for by another diagnosis.
- Report experiencing unremitting, continuous headaches with no relief.
- Have new daily persistent headache (NDPH) defined by iCHD-3 as persistent headache, daily from its onset, which is clearly remembered. The pain lacks characteristic features and may be migraine-like or tension-type like or have elements of both with a CM subtype.
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- History of treatments that could confound the results of the study
- Previously implanted neurostimulator to stimulate the greater occipital and/or supraorbital nerves to treat headache.
- Have received onabotulinumtoxinA (Botox) for any other medical or cosmetic reasons requiring injections in the head, face, or neck within 3 months prior to screening.
- Have had any cervical radiofrequency ablation within 12 months.
- Subjects with recent brain or facial trauma occurring less than 3 months prior to the Baseline Visit.
- Subjects that may have received sequential multi-day in-patient parenteral infusion for the treatment of a migraine condition (e.g., status migrainosus) within the previous 2 weeks of the initiation of diary screening phase.
- Subjects with any metallic implant located in the head including CSF shunt and surgical clip above the shoulder line (excluding dental implants).
- Subject has other implanted electrical stimulation device(s) including:
- Cardiac pacemakers or defibrillators
- Cochlear implant
- Intrathecal pumps
- Spinal cord stimulator
- Other stimulator device
- Use of nerve blocks, acupuncture, neurostimulation and/or transcranial magnetic stimulation) for migraine within 3 months prior to screening and after receiving implant system.
- Any pre-existing or requirement of emergent surgery/procedure that may interfere or confound the results of the study.
- Any known requirement for an MRI scan subsequent to implant of the neurostimulator.
- Current or history of following comorbidities:
- Clinically significant psychiatric illnesses, including suicide attempt, or suicidal ideation with a specific plan in the past 2 years.
- Cancer in the past 5 years, except for appropriately treated nonmelanoma skin carcinoma.
- Have a current diagnosis or condition that presents excess risk for performing the procedure, as determined clinically by the Investigator.
- Substance use disorder of at least moderate severe for substances such as; alcohol, recreational marijuana, or illicit drugs during the past 2 years.
- Unable to participate or successfully complete the study, in the opinion of the investigator.
- Anatomy not suitable for placement of the study device.
- Are currently a study center or Sponsor employee who is directly involved in the study or the relative of such an employee.
- Pregnant or lactating female or planning a pregnancy during participation in the study.
- Patient with life expectancy of less than 1.5 years.
- Currently participating in or planning to participate in other investigational drug or device studies that may interfere or confound the results of the study.
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States20 sites
Dent Neurologic Institute
Amherst, New York, 14226
Queen City Clinical Research
Charlotte, North Carolina, 28211
iSpine Clinics
Chaska, Minnesota, 55318
Synergy Headache Center & University of Illiniois Chicago
Chicago, Illinois, 60093
Texas Neurology
Dallas, Texas, 75206
Barolat Neuroscience
Denver, Colorado, 80218
Ayer Neuroscience Institute Headache Center
Hartford, Connecticut, 06106
Mayo Clinic Florida
Jacksonville, Florida, 32224
UC San Diego Health
La Jolla, California, 92037
Argires Marotti Neurological Associates
Lancaster, Pennsylvania, 17601
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of Minnesota
Minneapolis, Minnesota, 55455
Neurovations
Napa, California, 94558
Northwell Health Physician Partners
New York, New York, 10019
Montefiore Health
New York, New York, 10461
Vista Clinical Research and Summit Spine & Joint
Newnan, Georgia, 30265
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
Australia3 sites
Genesis Research Services
Broadmeadow, New South Wales
Monash House Research Centre
Melbourne, Victoria, 3170
CerCare
Wayville, South Australia
About this study
Official title: A PIVOTAL STUDY EVALUATING SAFETY AND EFFICACY OF THE SHIRATRONICS MIGRAINE THERAPY SYSTEM IN RELIEVING, INTERRUPTING, AND PREVENTING CHRONIC MIGRAINE (RELIEV-CM2)
Prospective, multi-center, double blind, randomized, sham-controlled study to evaluate neuromodulation in patient with chronic migraine. The study hypothesis to be tested is the mean reduction in mean monthly headache days between patients in treatment versus sham.
- Conditions
- Headache Migraine Chronic
- Being tested
- Neurostimulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurostimulatorDevice
Neurostimulation system that applies stimulation to nerve pathways in the head associated with migraine symptoms.
| Study group | Role | What they receive |
|---|---|---|
| High Dose | Active comparator | Not described Receives: Device: Neurostimulator |
| Low Dose | Sham comparator | Not described Receives: Device: Neurostimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Days
Mean monthly headache days
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start29 May 2024
- Primary completionMar 2027 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache Migraine ChronicStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ShiraTronics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Grosberg, MD, Principal investigator, Hartford Headache CenterSamer Narouze, MD, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167655
- Sponsor's protocol ID
- STCM02
- Status last verified
- Apr 2026
- First submitted
- 4 Dec 2023
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PIVOTAL STUDY EVALUATING SAFETY AND EFFICACY OF THE SHIRATRONICS MIGRAINE THERAPY SYSTEM IN RELIEVING, INTERRUPTING, AND PREVENTING CHRONIC MIGRAINE (RELIEV-CM2)
- ClinicalTrials.gov ID
- NCT06167655
- Acronym / sponsor ID
- STCM02
- Conditions
- Headache Migraine Chronic
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- ShiraTronicsIndustry (pharma, biotech, devices)
- Study start
- 29 May 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 12 Dec 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.
Prospective, multi-center, double blind, randomized, sham-controlled study to evaluate neuromodulation in patient with chronic migraine. The study hypothesis to be tested is the mean reduction in mean monthly headache days between patients in treatment versus sham.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Dose | Active comparator | Device: Neurostimulator |
| Low Dose | Sham comparator | Device: Neurostimulator |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥ 22 years of age.
- Have migraine onset at ≤ 50 years of age.
- Have a history of migraine for ≥ 12 months prior to screening.
- Have 15 - 26 headache days/month, among which ≥ 8 days has the features of probable migraine, and minimum of 2 headache-free days/month during the 28-day screening period.
- Fulfill the criteria for chronic migraine (CM) during the 28-day screening period.
Key exclusion criteria (33 listed)
- Type of headache or migraine other than RCM including the following:
- History of treatments that could confound the results of the study
- Have had any cervical radiofrequency ablation within 12 months.
- Subjects with recent brain or facial trauma occurring less than 3 months prior to the Baseline Visit.
- Subjects that may have received sequential multi-day in-patient parenteral infusion for the treatment of a migraine condition (e.g., status migrainosus) within the previous 2 weeks of the initiation of diary screening phase.
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 |
|---|---|---|
| NeurostimulatorNeurostimulation system that applies stimulation to nerve pathways in the head associated with migraine symptoms. | Device | High Dose, Low Dose |
Primary outcome
Headache Days
Time frame: 12-weeks
Mean monthly headache days
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 14 Apr 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.
Brian Grosberg, MD principal investigator
Hartford Headache Center
Samer Narouze, MD principal investigator
University Hospitals
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurostimulator in people with Headache Migraine Chronic, run by ShiraTronics at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 33 exclusion criteria. 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 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Australia. 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. Some participants in this study may receive a placebo. 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?
Headache Days (time frame: 12-weeks). 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 14 Apr 2026.