RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A PIVOTAL STUDY EVALUATING SAFETY AND EFFICACY OF THE SHIRATRONICS MIGRAINE THERAPY SYSTEM IN RELIEVING, INTERRUPTING, AND PREVENTING CHRONIC MIGRAINE (RELIEV-CM2)

Quick Facts

Study Start:2024-05-29

Study Completion:2026-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06167655

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.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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.	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 6 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. Subject has other implanted electrical stimulation device(s) or any metallic implant (excluding dental implants) including: 1. Cardiac pacemakers or defibrillators 2. Cochlear implant 3. CSF shunt 4. Surgical clip (above the shoulder line) 5. Intrathecal pumps 6. Spinal cord stimulator 7. Use of nerve blocks, acupuncture, neurostimulation and/or transcranial magnetic stimulation) for migraine within 3 months prior to screening and after receiving implant system. 8. Any pre-existing or requirement of emergent surgery/procedure that may interfere or confound the results of the study. 9. Any known requirement for an MRI scan subsequent to implant of the neurostimulator. 10. 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. 11. Unable to participate or successfully complete the study, in the opinion of the investigator. 12. Anatomy not suitable for placement of the study device. 13. Are currently a study center or Sponsor employee who is directly involved in the study or the relative of such an employee. 14. Pregnant or lactating female or planning a pregnancy during participation in the study. 15. Patient with life expectancy of less than 1.5 years. 16. Currently participating in or planning to participate in other investigational drug or device studies that may interfere or confound the results of the study.

Inclusion Criteria

Exclusion 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.
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.

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 6 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. Subject has other implanted electrical stimulation device(s) or any metallic implant (excluding dental implants) including:
1. Cardiac pacemakers or defibrillators
2. Cochlear implant
3. CSF shunt
4. Surgical clip (above the shoulder line)
5. Intrathecal pumps
6. Spinal cord stimulator
7. Use of nerve blocks, acupuncture, neurostimulation and/or transcranial magnetic stimulation) for migraine within 3 months prior to screening and after receiving implant system.
8. Any pre-existing or requirement of emergent surgery/procedure that may interfere or confound the results of the study.
9. Any known requirement for an MRI scan subsequent to implant of the neurostimulator.
10. 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.
11. Unable to participate or successfully complete the study, in the opinion of the investigator.
12. Anatomy not suitable for placement of the study device.
13. Are currently a study center or Sponsor employee who is directly involved in the study or the relative of such an employee.
14. Pregnant or lactating female or planning a pregnancy during participation in the study.
15. Patient with life expectancy of less than 1.5 years.
16. Currently participating in or planning to participate in other investigational drug or device studies that may interfere or confound the results of the study.

Contacts and Locations

Study Contact

Ecklund

CONTACT

1-844-228-7330

fecklund@shiratronics.com

Principal Investigator

Brian Grosberg, MD

PRINCIPAL_INVESTIGATOR

Hartford Headache Center

Samer Narouze, MD

PRINCIPAL_INVESTIGATOR

University Hospitals

Study Locations (Sites)

Neurovations

Napa, California, 94558

United States

Barolat Neuroscience

Denver, Colorado, 80218

United States

Vista Clinical Research and Summit Spine & Joint

Newnan, Georgia, 30265

United States

iSpine Clinics

Chaska, Minnesota, 55318

United States

Mayo Clinic Rochester

Rochester, Minnesota, 55905

United States

Dent Neurologic Institute

Amherst, New York, 14226

United States

Northwell Health Physician Partners

New York, New York, 10019

United States

Queen City Clinical Research

Charlotte, North Carolina, 28211

United States

The Center for Clinical Research

Winston-Salem, North Carolina, 27103

United States

Argires Marotti Neurological Associates

Lancaster, Pennsylvania, 17601

United States

Collaborators and Investigators

Sponsor: ShiraTronics

Brian Grosberg, MD, PRINCIPAL_INVESTIGATOR, Hartford Headache Center
Samer Narouze, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2024-05-29

Study Completion Date2026-08-30

Study Record Updates

Study Start Date2024-05-29

Study Completion Date2026-08-30

Terms related to this study

Additional Relevant MeSH Terms

Headache Migraine Chronic