Status:
RECRUITING
A PIVOTAL STUDY EVALUATING SAFETY AND EFFICACY OF THE SHIRATRONICS MIGRAINE THERAPY SYSTEM
Lead Sponsor:
ShiraTronics
Conditions:
Headache Migraine Chronic
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- ≥ 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.
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
May 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06167655
Start Date
May 29 2024
End Date
August 30 2026
Last Update
November 28 2025
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
UC San Diego Health
La Jolla, California, United States, 92037
4
Neurovations
Napa, California, United States, 94558