Feasibility Study of a Temporary Peripheral Nerve Stimulator
Not Applicable
Completed
- Conditions
- Nerve Injury
- Registration Number
- NCT04732936
- Lead Sponsor
- Epineuron Technologies Inc.
- Brief Summary
A novel temporary peripheral nerve stimulator will be evaluated for safety, usability, and preliminary efficacy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Semmes-Weinstein Monofilament Test 6 months Measurement of pressure sensitivity
Static Two Point Discrimination 6 months Measurement of spatial determination
DASH Questionnaire 6 months Validated questionnaire for functionality in upper extremity injury
Patient Tolerance to Therapy Questionnaire Immediately after procedure
- Secondary Outcome Measures
Name Time Method Device Usability Questionnaire Immediately after procedure Safety 6 months As measured by the cumulative incidence of adverse events.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular pathways are involved in nerve regeneration with temporary peripheral nerve stimulators in NCT04732936?
How does the temporary peripheral nerve stimulator compare to standard-of-care treatments for traumatic nerve injury outcomes?
Which biomarkers correlate with improved functional recovery in patients using Epineuron's nerve stimulator device?
What adverse events are associated with implantable nerve stimulation devices in peripheral nerve injury trials?
Are there combination therapies with neurotrophic factors or anti-inflammatory agents enhancing nerve stimulator efficacy in NCT04732936?
Trial Locations
- Locations (3)
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
McMaster University Medical Centre
🇨🇦Hamilton, Ontario, Canada
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada
Hamilton General Hospital🇨🇦Hamilton, Ontario, Canada