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| Name | Class |
|---|---|
| Federal Economic Development Agency for Southern Ontario (FedDev Ontario) | OTHER |
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A novel temporary peripheral nerve stimulation system that delivers electrical stimulation therapy in a cubital tunnel release model will be evaluated for feasibility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Intervention | Active Comparator | Standard of care plus therapy, which consists of a single, 1 hour dose of electrical stimulation. |
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| Control | No Intervention | Standard of care only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temporary Peripheral Nerve Stimulation System | Device | Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Eligibility Rate | Evaluation of study feasibility through the number of participants who pass all pre-operative screening eligibility criteria | 1.5 years |
| Recruitment Rate | Evaluation of study feasibility through the number of participants who complete informed consent and are randomized into a study arm | 1.5 years |
| Retention Rate | Evaluation of study feasibility through the number of participants who complete all study activities | 1.5 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Electromyography (EMG) Denervation Absence/Presence | Measurement of electrical activity of a muscle | 1.5 years |
| Nerve Conduction Study (NCS) | Measurement of speed of electrical impulse through a nerve |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katelyn So, MHSc | Contact | 905-206-0466 | clinops@epineurontech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Recruiting | Hamilton | Ontario | L8L 2X2 | Canada |
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| ID | Term |
|---|---|
| D009443 | Neuritis |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| 1.5 years |
| Semmes-Weinstein Monofilament Test | Evaluation of sensory recovery through the measurement of a pressure detection threshold | 1.5 years |
| Static Two-Point Discrimination | Evaluation of sensory recovery through the measurement of the threshold of discrimination | 1.5 years |
| Grip strength | Evaluation of functional recovery through the measurement of maximum grip strength | 1.5 years |
| Pinch strength | Evaluation of functional recovery through the measurement of pinch strength | 1.5 years |
| Patient Rated Ulnar Nerve Evaluation (PRUNE) | Evaluation of pain and quality of life through patient-reported questionnaire where lower scores indicate lower pain and better quality of life related to the injury | 1.5 years |
| McMaster University Medical Centre | Recruiting | Hamilton | Ontario | L8N 3Z5 | Canada |
|