A PIVOTAL STUDY EVALUATING SAFETY AND EFFICACY OF THE SHIRATRONICS MIGRAINE THERAPY SYSTEM
NCT ID: NCT06167655
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2024-05-29
2026-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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High Dose
Neurostimulator
Neurostimulation system that applies stimulation to nerve pathways in the head associated with migraine symptoms.
Low Dose
Neurostimulator
Neurostimulation system that applies stimulation to nerve pathways in the head associated with migraine symptoms.
Interventions
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Neurostimulator
Neurostimulation system that applies stimulation to nerve pathways in the head associated with migraine symptoms.
Eligibility Criteria
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Inclusion Criteria
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. 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.
22 Years
ALL
No
Sponsors
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ShiraTronics
INDUSTRY
Responsible Party
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Principal Investigators
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Brian Grosberg, MD
Role: PRINCIPAL_INVESTIGATOR
Hartford Headache Center
Samer Narouze, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals
Locations
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Mayo Clinic Arizona
Scottsdale, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
UC San Diego Health
La Jolla, California, United States
Neurovations
Napa, California, United States
Barolat Neuroscience
Denver, Colorado, United States
Ayer Neuroscience Institute Headache Center
Hartford, Connecticut, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Vista Clinical Research and Summit Spine & Joint
Newnan, Georgia, United States
Synergy Headache Center & University of Illiniois Chicago
Chicago, Illinois, United States
iSpine Clinics
Chaska, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Dent Neurologic Institute
Amherst, New York, United States
Northwell Health Physician Partners
New York, New York, United States
Montefiore Health
New York, New York, United States
Queen City Clinical Research
Charlotte, North Carolina, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
Argires Marotti Neurological Associates
Lancaster, Pennsylvania, United States
Jefferson Headache Center
Philadelphia, Pennsylvania, United States
Texas Neurology
Dallas, Texas, United States
Genesis Research Services
Broadmeadow, New South Wales, Australia
CerCare
Wayville, South Australia, Australia
Monash House Research Centre
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Other Identifiers
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STCM02
Identifier Type: -
Identifier Source: org_study_id
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