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| Name | Class |
|---|---|
| Goodman Campbell Brain and Spine, Indiana University, Indianapolis, Indiana, USA | UNKNOWN |
| International Spine, Pain and Performance Center, Washington DC, USA | UNKNOWN |
| Minimally Invasive Pain Institute, Utica, New York, USA |
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The purpose of this study is to assess the effectiveness of craniofacial nerve stimulation for the treatment of neuropathic pain.
Subjects will be randomized at enrollment into either a delayed or immediate continuation group. The immediate continuation group will immediately continue with the stimulation after a 30-day trial period and will be monitored for a total of 12 months. The delayed activation group will have their device turned off after the 30-day trial period for the next 3-months. At the 3-month visit, both groups be evaluated and the delayed activation group will have their devices reactivated.
Subjects will have neuropathic pain of various etiologies, including trauma, surgery or post-herpetic infections. Stimulators will be placed at the site target of the painful area, including the epifascial plane under the skin but above the muscles in the vicinity of the targeted branches of; A. Branches of Trigeminal Nerves in the Ophthalmic, Maxillary, or Mandibular B. Sensory branches of Facial Nerves C. Branches of the Occipital Nerves (Greater and/or Lesser) D. Branches of the Cervical Plexus (Superficial and/or Deep)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continued Stimulation Group | Experimental | Subjects randomized to this group will have the Halo Craniofacial Nerve Stimulator System activated immediately. |
|
| Delayed Continuation Group | Active Comparator | Subjects randomized to this group with have the Halo Craniofacial Nerve Stimulator System activated after 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Halo Craniofacial Nerve Stimulator System | Device | The Halo Craniofacial Nerve Stimulator System is a wirelessly powered neurostimulator for pain in the face or head (not for headaches or migraine). This technology includes an implanted stimulator with an embedded receiver. The energy source is a small, external, rechargeable transmitter, which is worn by the patient. The transmitter sends the therapy program and power through the skin to the receiver. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | To achieve a sustained 50% reduction in pain measured by the Visual Analog Scale (VAS) | 3 months |
| Incidence and severity of adverse events | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in VAS for facial pain | Baseline and 3 months | |
| Percent change from baseline in the Brief Pain Inventory-facial (BPIF) Questionnaire | Baseline and 3 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Spine, Pain & Performance Center | Washington D.C. | District of Columbia | 20037 | United States | ||
De-identified participant data for all primary endpoints will be made available within 6 months of study completion.
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| Case Western Reserve University, Cleveland, Ohio, USA | UNKNOWN |
| Pennsylvania Hospital, Philadelphia, Pennsylvania, USA | UNKNOWN |
| Baylor College of Medicine | OTHER |
| Prizm Pain Management, Canton, Michigan | UNKNOWN |
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| Subject satisfaction with the therapy as measured by the Patient Global Impression of Change (PGIC) |
| 3 months |
| Change from baseline in quality of life, Physical component score using Medical Outcomes Short Form SF-36 | Baseline and 3 months |
| Change from baseline in quality of life, Mental component score using Medical Outcomes Short Form SF-36 | Baseline and 3 months |
| Change from baseline in pain rating index from the Short Form McGill Pain Questionnaire (MPQ-SF-2) | Baseline and 3 months |
| Goodman Campbell Brain and Spine, Indiana University |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Prizm Pain Management | Canton | Michigan | 48187 | United States |
| Minimally Invasive Pain Institute | Utica | New York | 13502 | United States |
| University Hospitals Case Medical Center, Department of Anesthesiology, Division of Pain Medicine | Cleveland | Ohio | 44106 | United States |
| Pennsylvania Hospital, Dept. of Neurosurgery | Philadelphia | Pennsylvania | 19106 | United States |
| baylor College of Medicine | Houston | Texas | 77030 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 28, 2026 | May 19, 2026 | 14 |
| ID | Term |
|---|---|
| D005157 | Facial Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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