Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury

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

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.

Study Overview

• Status: Terminated
• Conditions: Bell Palsy; Hemifacial Paralysis
• Intervention / Treatment: Device: Electrical Stimulation; Device: Sham Treatment

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Electrical Stimulation; Electrical Stimulation The patient will receive active electrical stimulation.	Device: Electrical Stimulation; 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.
PLACEBO_COMPARATOR: Sham Treatment; No Electrical Stimulation The patient will receive sham electrical stimulation.	Device: Sham Treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pre-Operative Lip Excursion with Smile	FACEGRAM will be used to objectively analyse change in commissure excursion.	Change from Baseline (Pre-Op) over 2 Years
Change in Myelinated Axon Count	The number of myelinated nerve fibres that regenerate and reach the distal CFNG will be compared between groups.	Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Facial Symmetry	FACEGRAM will be used to objectively analyse smile symmetry.	Change from Baseline (Pre-Op) over 2 Years
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.	Change from Baseline (Pre-Op) Over 2 Years
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.	Up to 1 year after the Second Operation (FMT)
Myelin Thickness	Using histomorphometry, Myelin Thickness will be used as a surrogate measure for the rate of axon regeneration.	Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later
Nerve Fibre Diameter	Using histomorphometry, Nerve Fibre Diameter will be used as a surrogate measure for the rate of axon regeneration.	Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later
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.	Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: The Physicians' Services Incorporated Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 16, 2019
• Primary Completion (ACTUAL): October 3, 2022
• Study Completion (ACTUAL): October 3, 2022

Study Registration Dates

• First Submitted: June 20, 2019
• First Submitted That Met QC Criteria: June 21, 2019
• First Posted (ACTUAL): June 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: electrical stimulation; FMT; facial paralysis; facial nerve palsy; peripheral nerve stimulation; unilateral facial nerve palsy; facial palsy; cross facial nerve graft; CFNG; e-stim; free muscle transfer
• Additional Relevant MeSH Terms: Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Wounds and Injuries; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; DNA Virus Infections; Trauma, Nervous System; Cranial Nerve Diseases; Herpesviridae Infections; Facial Nerve Diseases; Paralysis; Bell Palsy; Facial Paralysis; Peripheral Nerve Injuries
• Other Study ID Numbers: 1000063546

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No