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The purpose of this study is to learn if pain can be relieved by delivering small amounts of electricity (called "electrical stimulation") to the nerves at the top of the neck. This study will use a device called the SPRINT® PNS System. PNS stands for peripheral nerve stimulation (PNS). This device is cleared by the FDA for up to 60 days of use for relief of chronic or acute pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peripheral Nerve Stimulation | Experimental | All study subjects will have up to 2 leads placed in the back of their neck, will use the SPRINT Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPRINT Peripheral Nerve Stimulation (PNS) System | Device | The SPRINT System delivers mild electrical stimulation to the occipital nerves. The SPRINT System includes up to two leads (small wires) that are placed through your skin at the top of your neck. The leads attach to devices worn on your body that deliver stimulation (called Stimulators). |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in average pain and/or reduction in pain interference. | Average pain is measured using question 5 from the Brief Pain Inventory-Short Form (BPI-5) and pain interference is measured using question 9 from the Brief Pain Inventory-Short Form (BPI-9). BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. BPI-9 is a scale of 0 to 10 where 0 represents no interference and 10 represents complete interference. | Up to 8-weeks after Start of Therapy (SOT) |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | During the Lead Placement procedure (SOT) |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 24-48 hours post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 1-week post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 2-weeks post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 3-weeks post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 4-weeks post-SOT |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in average pain intensity | Average pain scores measured using question 5 from the Brief Pain Inventory- Short Form. | Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT |
| Reduction in pain interference |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Research Institute | Santa Rosa | California | 95403 | United States | ||
| MedVadis Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40391557 | Derived | Gutierrez GG, McCormick ZL, Engle MP, Gilmore CA, Pingree MJ, Pope JE, DiBenedetto DJ, Kissoon NR, Sayal PK, Zurn CA, Crosby ND, Boggs JW. A multicenter, prospective, single-arm study of 60-day peripheral nerve stimulation of the occipital nerves for the treatment of headache. Headache. 2025 Nov-Dec;65(10):1776-1787. doi: 10.1111/head.14948. Epub 2025 May 20. |
| Label | URL |
|---|---|
| Sponsor's Website | View source |
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|
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 5-weeks post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 6-weeks post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 7-weeks post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 8-weeks post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 3-months post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 6-months post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 9-months post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 12-months post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 18-months post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 24-months post-SOT |
Average pain interference scores measured using question 9 from the Brief Pain Inventory- Short Form. |
| Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT |
| Reduction in pain medication usage | Analgesic medication consumption will be collected. | Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT |
| Waltham |
| Massachusetts |
| 02451 |
| United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Center of Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Pain Specialists of America - South Austin - James Casey | Austin | Texas | 78745 | United States |
| Pain Specialists of America - Cedar Park | Cedar Park | Texas | 78613 | United States |
| Institute of Precision Pain Medicine | Corpus Christi | Texas | 78414 | United States |
| Pain Specialists of America - Round Rock | Round Rock | Texas | 78681 | United States |
| Pain Specialists of America - San Marcos | San Marcos | Texas | 78666 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| ID | Term |
|---|---|
| D051298 | Post-Traumatic Headache |
| D006261 | Headache |
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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