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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Nerve Injury

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