Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury

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

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-16

Study Completion Date

2022-10-03

Brief Summary

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After nerve injury and facial palsy, many patients have permanent muscle and sensory dysfunction. Electrical stimulation (ES) of injured nerves may speed up axon growth and improve recovery. This study will assess if ES accelerates motor axon regeneration and improves muscle recovery in patients undergoing two-staged facial reanimation for facial palsy.

This study of ES in these patients will investigate:

i) nerve regeneration over long distances;

ii) direct evidence of changes in nerve regeneration with nerve samples from the second procedure; and

iii) changes in functional outcomes in a patient population with much less variability.

Our study will provide evidence about the effect of ES in improving outcomes in patients with nerve injuries.

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Detailed Description

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Conditions

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Hemifacial Paralysis Bell 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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Electrical Stimulation

Electrical Stimulation

The patient will receive active electrical stimulation.

Group Type EXPERIMENTAL

Electrical Stimulation

Intervention Type DEVICE

Two-Stage Facial Reanimation (Standard Practice) with electrical stimulation for one hour at 20Hz (Experimental Procedure).

1. Cross-Facial Nerve Graft (CFNG) immediately followed by electrical nerve stimulation proximal to the coaptation site on the donor facial nerve.
2. Nine-to-Twelve Months later, Free Muscle Transfer (FMT) followed by electrical nerve stimulation proximal to the coaptation site in the intraoral incision.

Sham Treatment

No Electrical Stimulation

The patient will receive sham electrical stimulation.

Group Type PLACEBO_COMPARATOR

Sham Treatment

Intervention Type DEVICE

Two-Stage Facial Reanimation (Standard Practice) with sham electrical stimulation for one hour (Placebo).

1. Cross-Facial Nerve Graft (CFNG) followed by placement of unelectrified electrodes proximal to the coaptation site on the donor facial nerve.
2. Free Muscle Transfer (FMT) followed by placement of unelectrified electrodes proximal to the coaptation site in the intraoral incision.

Interventions

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Electrical Stimulation

Two-Stage Facial Reanimation (Standard Practice) with electrical stimulation for one hour at 20Hz (Experimental Procedure).

1. Cross-Facial Nerve Graft (CFNG) immediately followed by electrical nerve stimulation proximal to the coaptation site on the donor facial nerve.
2. Nine-to-Twelve Months later, Free Muscle Transfer (FMT) followed by electrical nerve stimulation proximal to the coaptation site in the intraoral incision.

Intervention Type DEVICE

Sham Treatment

Two-Stage Facial Reanimation (Standard Practice) with sham electrical stimulation for one hour (Placebo).

1. Cross-Facial Nerve Graft (CFNG) followed by placement of unelectrified electrodes proximal to the coaptation site on the donor facial nerve.
2. Free Muscle Transfer (FMT) followed by placement of unelectrified electrodes proximal to the coaptation site in the intraoral incision.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Patients undergoing unilateral facial reanimation with a two-stage cross-face nerve graft and free gracilis muscle flap transfer who have;

* i) isolated unilateral facial nerve palsy and
* ii) a functioning contralateral facial nerve.

Exclusion Criteria

* Any disorders that may compromise nerve regeneration or muscle function following muscle transfer, including diabetes, polyneuropathy, or myopathy and muscular dystrophy.
* Patients with severe cognitive impairment, which would limit their participation

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No