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A novel temporary peripheral nerve stimulator will be evaluated for safety, usability, and preliminary efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Usability | Experimental | Device usability and safety will be evaluated. |
|
| Preliminary Efficacy | Experimental | Preliminary treatment efficacy will be evaluated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temporary Peripheral Nerve Stimulator | Device | Temporary Peripheral Nerve Stimulator to deliver 1-hr of electrical stimulation to injured nerves. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Tolerance to Therapy Questionnaire | Immediately after procedure | |
| Static Two Point Discrimination | Measurement of spatial determination | 6 months |
| Semmes-Weinstein Monofilament Test | Measurement of pressure sensitivity | 6 months |
| DASH Questionnaire | Validated questionnaire for functionality in upper extremity injury | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | As measured by the cumulative incidence of adverse events. | 6 months |
| Device Usability Questionnaire | Immediately after procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Coroneos, MD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Hamilton | Ontario | L8L2X2 | Canada | ||
| McMaster University Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40275339 | Derived | Coroneos CJ, Levis C, Willand MP, So KJ, Bain JR. Clinical evaluation of a novel disposable neurostimulator used to accelerate regeneration of injured peripheral nerves in the hand. Bioelectron Med. 2025 Apr 25;11(1):9. doi: 10.1186/s42234-025-00171-y. |
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| Hamilton |
| Ontario |
| L8N3Z5 |
| Canada |
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N4A6 | Canada |