Feasibility Study of a Temporary Peripheral Nerve Stimulator

July 12, 2023 updated by: Epineuron Technologies Inc.
A novel temporary peripheral nerve stimulator will be evaluated for safety, usability, and preliminary efficacy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L2X2
        • Hamilton General Hospital
      • Hamilton, Ontario, Canada, L8N4A6
        • St. Joseph's Healthcare Hamilton
      • Hamilton, Ontario, Canada, L8N3Z5
        • McMaster University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Device Usability
Device usability and safety will be evaluated.
Device: Temporary Peripheral Nerve Stimulator
Temporary Peripheral Nerve Stimulator to deliver 1-hr of electrical stimulation to injured nerves.
Experimental: Preliminary Efficacy
Preliminary treatment efficacy will be evaluated.
Device: Temporary Peripheral Nerve Stimulator
Temporary Peripheral Nerve Stimulator to deliver 1-hr of electrical stimulation to injured nerves.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Tolerance to Therapy Questionnaire
Time Frame: Immediately after procedure
Immediately after procedure
Static Two Point Discrimination
Time Frame: 6 months
Measurement of spatial determination
6 months
Semmes-Weinstein Monofilament Test
Time Frame: 6 months
Measurement of pressure sensitivity
6 months
DASH Questionnaire
Time Frame: 6 months
Validated questionnaire for functionality in upper extremity injury
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 6 months
As measured by the cumulative incidence of adverse events.
6 months
Device Usability Questionnaire
Time Frame: Immediately after procedure
Immediately after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epineuron Technologies Inc.

Investigators

  • Principal Investigator: Christopher Coroneos, MD, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

June 21, 2023

Study Completion (Actual)

June 21, 2023

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 1, 2021

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • EPNR-CIP-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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