Promoting Healing of Injured Nerves With Electrical Stimulation Therapy

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-12

Study Completion Date

2027-06-30

Brief Summary

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This study is evaluating a new therapeutic use of electrical stimulation to promote nerve healing and improve functional recovery following surgical intervention for peripheral nerve injury in arm. Participants will be randomized into one of two groups, treatment or control, with all participants receiving standard of care treatment for the nerve injury. The treatment group will also receive a single dose of the therapeutic stimulation during the surgical intervention for their nerve injury.

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Detailed Description

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Preliminary research has shown that delivering a brief period of electrical stimulation following nerve repair promotes nerve healing and functional recovery. This pilot study is investigating the use of a single dose of therapeutic electrical stimulation to promote nerve healing. The therapy is delivered as part of the surgical intervention to address peripheral nerve injury in the arm.

Conditions

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Nerve Injury Peripheral Nerve Injuries Peripheral Nerve Injury Upper Limb Nerve Palsy

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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Brief Electrical Stimulation Therapy

Single, 10 minute dose of electrical stimulation delivered to the injured nerve during surgical intervention.

Group Type EXPERIMENTAL

Checkpoint BEST System

Intervention Type DEVICE

Single use medical device, consisting of electric stimulator and intraoperative lead. Therapy consists of single, 10 minute dose delivered proximal to site of decompression/repair

Standard of Care

Surgical intervention for repair of peripheral nerve injury.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Checkpoint BEST System

Single use medical device, consisting of electric stimulator and intraoperative lead. Therapy consists of single, 10 minute dose delivered proximal to site of decompression/repair

Intervention Type DEVICE

Other Intervention Names

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Brief Electrical Stimulation (BES) Therapy

Eligibility Criteria

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Inclusion Criteria

* Upper extremity mixed or motor nerve injury from the brachial plexus to the wrist crease.
* Candidate for surgical intervention.
* Indicated for surgical repair by nerve transfer, primary repair, or nerve grafting.
* Are age 18-80 years.
* Signed and dated informed consent form.

Exclusion Criteria

* Severe comorbid condition, such as arrhythmia or congestive heart failure, preventing surgery.
* Primary repair requiring graft \>6cm.
* Nerve reconstruction occurring \>12 months post injury.
* Age less than 18 or greater than 80 years.
* All contraindications to included/required surgical procedure, including but not limited to language barriers, mental status barriers, inability to consent, and pregnancy/lactation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No