Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation

NCT ID: NCT05721261

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-11

Study Completion Date

2025-12-31

Brief Summary

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A novel temporary peripheral nerve stimulation system that delivers a single dose of electrical stimulation therapy for 1 hour will be evaluated for safety and effectiveness.

Detailed Description

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Conditions

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Nerve Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active treatment

Group Type EXPERIMENTAL

Temporary Peripheral Nerve Stimulation System

Intervention Type DEVICE

Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation delivered proximal to injury site.

Sham treatment

Group Type SHAM_COMPARATOR

Sham Temporary Peripheral Nerve Stimulation System

Intervention Type DEVICE

Single use medical device. Sham treatment consists of single, 1 hour dose of sham stimulation.

Interventions

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Temporary Peripheral Nerve Stimulation System

Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation delivered proximal to injury site.

Intervention Type DEVICE

Sham Temporary Peripheral Nerve Stimulation System

Single use medical device. Sham treatment consists of single, 1 hour dose of sham stimulation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Peripheral nerve injury

Exclusion Criteria

* Peripheral neuropathy
* Patients with any active implanted device
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Epineuron Technologies Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Florida Health

Gainesville, Florida, United States

Site Status RECRUITING

Orlando Health Jewett Orthopedic Institute

Orlando, Florida, United States

Site Status RECRUITING

The Curtis National Hand Center

Baltimore, Maryland, United States

Site Status ACTIVE_NOT_RECRUITING

WellSpan Health

York, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

John Peter Smith Hospital

Fort Worth, Texas, United States

Site Status RECRUITING

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status RECRUITING

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Site Status RECRUITING

Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status RECRUITING

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status RECRUITING

Roth | McFarlane Hand & Upper Limb Centre

London, Ontario, Canada

Site Status RECRUITING

North York General Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Trillium Health Partners

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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United States Canada

Central Contacts

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Tracy Cameron, PhD

Role: CONTACT

905-206-0466

Other Identifiers

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EPNR-CIP-002

Identifier Type: -

Identifier Source: org_study_id

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