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Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury

Primary Purpose

Hemifacial Paralysis, Bell Palsy

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Electrical Stimulation

Sham Treatment

About this trial

This is an interventional treatment trial for Hemifacial Paralysis focused on measuring unilateral facial nerve palsy, facial nerve palsy, facial palsy, facial paralysis, cross facial nerve graft, CFNG, peripheral nerve stimulation, electrical stimulation, e-stim, free muscle transfer, FMT

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Electrical Stimulation

Sham Treatment

Arm Description

Electrical Stimulation The patient will receive active electrical stimulation.

No Electrical Stimulation The patient will receive sham electrical stimulation.

Outcomes

Primary Outcome Measures

Change in Pre-Operative Lip Excursion with Smile

FACEGRAM will be used to objectively analyse change in commissure excursion.

Change in Myelinated Axon Count

The number of myelinated nerve fibres that regenerate and reach the distal CFNG will be compared between groups.

Secondary Outcome Measures

Change in Facial Symmetry

FACEGRAM will be used to objectively analyse smile symmetry.

Facial Clinimetric Evaluation (FaCE) Scores

The Facial Clinimetric Evaluation (FaCE) Scale is a patient-report questionnaire assessing facial impairment and disability associated with facial paralysis. The 15-item likert scale questionnaire consists of six domains: i) facial movement, ii) facial comfort, iii) oral function, iv) eye comfort, v) lacrimal control and vi) social function. Each domain produces its own score, with 1 meaning 'problems all the time' and 5 suggesting 'no problems at all.' The domain scores can then be summed to produce a total score assessing total quality of life with respect to facial paralysis.

Time to Reinnervation

Study participants are requested to monitor their facial movements and record any changes in a daily diary once they first notice facial movement.

Myelin Thickness

Using histomorphometry, Myelin Thickness will be used as a surrogate measure for the rate of axon regeneration.

Nerve Fibre Diameter

Using histomorphometry, Nerve Fibre Diameter will be used as a surrogate measure for the rate of axon regeneration.

Myelin Thickness/Fibre Diameter Ratio

Using histomorphometry, Myelin Thickness/Fibre Diameter Ratio will be used as a surrogate measure for the rate of axon regeneration.

Full Information

NCT ID

NCT03996525

First Posted

June 20, 2019

Last Updated

February 9, 2023

Sponsor

The Hospital for Sick Children

Collaborators

The Physicians' Services Incorporated Foundation

1. Study Identification

Unique Protocol Identification Number

NCT03996525

Brief Title

Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury

Official Title

Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury - A Randomized Controlled Prospective Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Terminated

Why Stopped

COVID-19 Pandemic

Study Start Date

September 16, 2019 (Actual)

Primary Completion Date

October 3, 2022 (Actual)

Study Completion Date

October 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hospital for Sick Children

Collaborators

The Physicians' Services Incorporated Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemifacial Paralysis, Bell Palsy

Keywords

unilateral facial nerve palsy, facial nerve palsy, facial palsy, facial paralysis, cross facial nerve graft, CFNG, peripheral nerve stimulation, electrical stimulation, e-stim, free muscle transfer, FMT

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Electrical Stimulation

Arm Type

Experimental

Arm Description

Electrical Stimulation The patient will receive active electrical stimulation.

Arm Title

Sham Treatment

Arm Type

Placebo Comparator

Arm Description

No Electrical Stimulation The patient will receive sham electrical stimulation.

Intervention Type

Device

Intervention Name(s)

Electrical Stimulation

Intervention Description

Two-Stage Facial Reanimation (Standard Practice) with electrical stimulation for one hour at 20Hz (Experimental Procedure). Cross-Facial Nerve Graft (CFNG) immediately followed by electrical nerve stimulation proximal to the coaptation site on the donor facial nerve. 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

Intervention Name(s)

Sham Treatment

Intervention Description

Two-Stage Facial Reanimation (Standard Practice) with sham electrical stimulation for one hour (Placebo). Cross-Facial Nerve Graft (CFNG) followed by placement of unelectrified electrodes proximal to the coaptation site on the donor facial nerve. Free Muscle Transfer (FMT) followed by placement of unelectrified electrodes proximal to the coaptation site in the intraoral incision.

Primary Outcome Measure Information:

Title

Change in Pre-Operative Lip Excursion with Smile

Description

FACEGRAM will be used to objectively analyse change in commissure excursion.

Time Frame

Change from Baseline (Pre-Op) over 2 Years

Title

Change in Myelinated Axon Count

Description

The number of myelinated nerve fibres that regenerate and reach the distal CFNG will be compared between groups.

Time Frame

Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later

Secondary Outcome Measure Information:

Title

Change in Facial Symmetry

Description

FACEGRAM will be used to objectively analyse smile symmetry.

Time Frame

Change from Baseline (Pre-Op) over 2 Years

Title

Facial Clinimetric Evaluation (FaCE) Scores

Description

Time Frame

Change from Baseline (Pre-Op) Over 2 Years

Title

Time to Reinnervation

Description

Study participants are requested to monitor their facial movements and record any changes in a daily diary once they first notice facial movement.

Time Frame

Up to 1 year after the Second Operation (FMT)

Title

Myelin Thickness

Description

Using histomorphometry, Myelin Thickness will be used as a surrogate measure for the rate of axon regeneration.

Time Frame

Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later

Title

Nerve Fibre Diameter

Description

Using histomorphometry, Nerve Fibre Diameter will be used as a surrogate measure for the rate of axon regeneration.

Time Frame

Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later

Title

Myelin Thickness/Fibre Diameter Ratio

Description

Using histomorphometry, Myelin Thickness/Fibre Diameter Ratio will be used as a surrogate measure for the rate of axon regeneration.

Time Frame

Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristen Davidge, MD

Organizational Affiliation

The Hospital for Sick Children

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ronald Zuker, MD

Organizational Affiliation

The Hospital for Sick Children

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Hospital for Sick Children

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X8

Country

Canada

12. IPD Sharing Statement

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Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury

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