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NCT04732936 Clinical Trial

Feasibility Study of a Temporary Peripheral Nerve Stimulator

Nerve Injury Clinical Trial

Official title:
Feasibility Study of a Temporary Peripheral Nerve Stimulator

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04732936
Other study ID # EPNR-CIP-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date June 21, 2023

Study information
Verified date July 2023
Source Epineuron Technologies Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A novel temporary peripheral nerve stimulator will be evaluated for safety, usability, and preliminary efficacy.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date June 21, 2023
Est. primary completion date June 21, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Temporary Peripheral Nerve Stimulator
Temporary Peripheral Nerve Stimulator to deliver 1-hr of electrical stimulation to injured nerves.

Locations
Country Name City State
Canada Hamilton General Hospital Hamilton Ontario
Canada McMaster University Medical Centre Hamilton Ontario
Canada St. Joseph's Healthcare Hamilton Hamilton Ontario

Sponsors (1)
Lead Sponsor Collaborator
Epineuron Technologies Inc.

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient Tolerance to Therapy Questionnaire Immediately after procedure
Primary Static Two Point Discrimination Measurement of spatial determination 6 months
Primary Semmes-Weinstein Monofilament Test Measurement of pressure sensitivity 6 months
Primary DASH Questionnaire Validated questionnaire for functionality in upper extremity injury 6 months
Secondary Safety As measured by the cumulative incidence of adverse events. 6 months
Secondary Device Usability Questionnaire Immediately after procedure
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