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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose | Active Comparator |
| |
| Low Dose | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurostimulator | Device | Neurostimulation system that applies stimulation to nerve pathways in the head associated with migraine symptoms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Headache Days | Mean monthly headache days | 12-weeks |
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Inclusion Criteria:
Exclusion Criteria:
Type of headache or migraine other than RCM including the following:
History of treatments that could confound the results of the study
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:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Brian Grosberg, MD | Hartford Headache Center | Principal Investigator |
| Samer Narouze, MD | University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | United States | ||
| University of Arkansas for Medical Sciences |
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| Little Rock |
| Arkansas |
| 72205 |
| United States |
| UC San Diego Health | La Jolla | California | 92037 | United States |
| Neurovations | Napa | California | 94558 | United States |
| Barolat Neuroscience | Denver | Colorado | 80218 | United States |
| Ayer Neuroscience Institute Headache Center | Hartford | Connecticut | 06106 | United States |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| Vista Clinical Research and Summit Spine & Joint | Newnan | Georgia | 30265 | United States |
| Synergy Headache Center & University of Illiniois Chicago | Chicago | Illinois | 60093 | United States |
| iSpine Clinics | Chaska | Minnesota | 55318 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | 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 |
| Montefiore Health | New York | New York | 10461 | 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 |
| Jefferson Headache Center | Philadelphia | Pennsylvania | 19107 | United States |
| Texas Neurology | Dallas | Texas | 75206 | United States |
| Genesis Research Services | Broadmeadow | New South Wales | Australia |
| CerCare | Wayville | South Australia | Australia |
| Monash House Research Centre | Melbourne | Victoria | 3170 | Australia |
| ID | Term |
|---|---|
| D058542 | Implantable Neurostimulators |
| ID | Term |
|---|---|
| D004567 | Electrodes, Implanted |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
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