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

NCT06167655 | Active Not Recruiting DMC FDA Device

• 1 other identifier: STCM02
• Study Type: interventional
• Target: 250
• Locations: 2 countries
• Sites: 23

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 monthly headache days between patients in treatment versus sham.

Conditions

Headache Migraine Chronic

Outcome Measures

Primary Outcomes (1)

• Headache Days

  Mean monthly headache days

  12-weeks

Study Arms (2)

High Dose

ACTIVE COMPARATOR

Device: Neurostimulator

Low Dose

SHAM COMPARATOR

Device: Neurostimulator

Interventions

Neurostimulator DEVICE

Neurostimulation system that applies stimulation to nerve pathways in the head associated with migraine symptoms.

High Dose; Low Dose

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ShiraTronics: lead

Study Sites (23)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

UC San Diego Health

La Jolla, California, 92037, United States

Location

Neurovations

Napa, California, 94558, United States

Location

Barolat Neuroscience

Denver, Colorado, 80218, United States

Location

Ayer Neuroscience Institute Headache Center

Hartford, Connecticut, 06106, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Vista Clinical Research and Summit Spine & Joint

Newnan, Georgia, 30265, United States

Location

Synergy Headache Center & University of Illiniois Chicago

Chicago, Illinois, 60093, United States

Location

iSpine Clinics

Chaska, Minnesota, 55318, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Dent Neurologic Institute

Amherst, New York, 14226, United States

Location

Northwell Health Physician Partners

New York, New York, 10019, United States

Location

Montefiore Health

New York, New York, 10461, United States

Location

Queen City Clinical Research

Charlotte, North Carolina, 28211, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Argires Marotti Neurological Associates

Lancaster, Pennsylvania, 17601, United States

Location

Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Location

Texas Neurology

Dallas, Texas, 75206, United States

Location

Genesis Research Services

Broadmeadow, New South Wales, Australia

Location

CerCare

Wayville, South Australia, Australia

Location

Monash House Research Centre

Melbourne, Victoria, 3170, Australia

Location

MeSH Terms

Interventions

Implantable Neurostimulators

Intervention Hierarchy (Ancestors)

Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants

Study Officials

• Brian Grosberg, MD

  Hartford Headache Center

  PRINCIPAL INVESTIGATOR

• Samer Narouze, MD

  University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: May 29, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2031
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (20); AU (3)