A PIVOTAL STUDY EVALUATING SAFETY AND EFFICACY OF THE SHIRATRONICS MIGRAINE THERAPY SYSTEM

April 13, 2026 updated by: ShiraTronics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Broadmeadow, New South Wales, Australia
        • Genesis Research Services
    • South Australia
      • Wayville, South Australia, Australia
        • CerCare
    • Victoria
      • Melbourne, Victoria, Australia, 3170
        • Monash House Research Centre
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Arizona
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • La Jolla, California, United States, 92037
        • UC San Diego Health
      • Napa, California, United States, 94558
        • Neurovations
    • Colorado
      • Denver, Colorado, United States, 80218
        • Barolat Neuroscience
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Ayer Neuroscience Institute Headache Center
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Vista Clinical Research and Summit Spine & Joint
    • Illinois
      • Chicago, Illinois, United States, 60093
        • Synergy Headache Center & University of Illiniois Chicago
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • iSpine Clinics
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurologic Institute
      • New York, New York, United States, 10019
        • Northwell Health Physician Partners
      • New York, New York, United States, 10461
        • Montefiore Health
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Queen City Clinical Research
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
        • Argires Marotti Neurological Associates
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson Headache Center
    • Texas
      • Dallas, Texas, United States, 75206
        • Texas Neurology

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≥ 22 years of age.
  2. Have migraine onset at ≤ 50 years of age.
  3. Have a history of migraine for ≥ 12 months prior to screening.
  4. 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.
  5. Fulfill the criteria for chronic migraine (CM) during the 28-day screening period.
  6. 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.
  7. 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.
  8. Demonstrate ≥ 80% compliance with the headache diary during the screening period by entering headache data on a minimum of 22 out of 28 days.
  9. 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.
  10. Be able to give voluntary, written informed consent to participate in this study.

Exclusion Criteria:

  1. Type of headache or migraine other than RCM including the following:

    1. Post-traumatic headache (e.g., battlefield, accidents, etc.).
    2. 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.
    3. 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.
    4. Report experiencing unremitting, continuous headaches with no relief.
    5. 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.

  2. History of treatments that could confound the results of the study

    1. Previously implanted neurostimulator to stimulate the greater occipital and/or supraorbital nerves to treat headache.
    2. 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.
  3. Have had any cervical radiofrequency ablation within 12 months.
  4. Subjects with recent brain or facial trauma occurring less than 3 months prior to the Baseline Visit.
  5. 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.
  6. Subjects with any metallic implant located in the head including CSF shunt and surgical clip above the shoulder line (excluding dental implants).

  7. Subject has other implanted electrical stimulation device(s) including:

    1. Cardiac pacemakers or defibrillators
    2. Cochlear implant
    3. Intrathecal pumps
    4. Spinal cord stimulator
    5. Other stimulator device
  8. Use of nerve blocks, acupuncture, neurostimulation and/or transcranial magnetic stimulation) for migraine within 3 months prior to screening and after receiving implant system.
  9. Any pre-existing or requirement of emergent surgery/procedure that may interfere or confound the results of the study.
  10. Any known requirement for an MRI scan subsequent to implant of the neurostimulator.

  11. Current or history of following comorbidities:

    1. Clinically significant psychiatric illnesses, including suicide attempt, or suicidal ideation with a specific plan in the past 2 years.
    2. Cancer in the past 5 years, except for appropriately treated nonmelanoma skin carcinoma.
    3. Have a current diagnosis or condition that presents excess risk for performing the procedure, as determined clinically by the Investigator.
    4. Substance use disorder of at least moderate severe for substances such as; alcohol, recreational marijuana, or illicit drugs during the past 2 years.
  12. Unable to participate or successfully complete the study, in the opinion of the investigator.
  13. Anatomy not suitable for placement of the study device.
  14. Are currently a study center or Sponsor employee who is directly involved in the study or the relative of such an employee.
  15. Pregnant or lactating female or planning a pregnancy during participation in the study.
  16. Patient with life expectancy of less than 1.5 years.
  17. Currently participating in or planning to participate in other investigational drug or device studies that may interfere or confound the results of the study.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: High Dose
Device: Neurostimulator
Neurostimulation system that applies stimulation to nerve pathways in the head associated with migraine symptoms.
Sham Comparator: Low Dose
Device: Neurostimulator
Neurostimulation system that applies stimulation to nerve pathways in the head associated with migraine symptoms.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Headache Days
Time Frame: 12-weeks
Mean monthly headache days
12-weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ShiraTronics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brian Grosberg, MD, Hartford Headache Center
  • Principal Investigator: Samer Narouze, MD, University Hospitals

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STCM02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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