Nerve Injury
Conditions
Brief summary
A novel temporary peripheral nerve stimulator will be evaluated for safety, usability, and preliminary efficacy.
Interventions
DEVICETemporary Peripheral Nerve Stimulator
Temporary Peripheral Nerve Stimulator to deliver 1-hr of electrical stimulation to injured nerves.
Sponsors
Epineuron Technologies Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Are between 18-65 years old * Have a Sunderland II-V peripheral nerve injury of the upper extremity * Are receiving surgery within 14 days of injury
Exclusion criteria
* Nerve plexus injuries (e.g. brachial plexus) * Nerve gap requiring graft/conduit, or extreme joint flexion * Polyneuropathies * Cognitive impairment and non-English-speaking * Uncontrolled diabetes * Surgical intervention \> 14 days of injury * Co-enrollment in another clinical trial * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Tolerance to Therapy Questionnaire | Immediately after procedure | — |
| Static Two Point Discrimination | 6 months | Measurement of spatial determination |
| Semmes-Weinstein Monofilament Test | 6 months | Measurement of pressure sensitivity |
| DASH Questionnaire | 6 months | Validated questionnaire for functionality in upper extremity injury |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 6 months | As measured by the cumulative incidence of adverse events. |
| Device Usability Questionnaire | Immediately after procedure | — |
Countries
Canada
Outcome results
None listed