Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury

NCT03996525 | Terminated

• 1 other identifier: 1000063546
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change in Facial Symmetry

  Change from Baseline (Pre-Op) over 2 Years

• Facial Clinimetric Evaluation (FaCE) Scores

  Change from Baseline (Pre-Op) Over 2 Years

• Time to Reinnervation

  Up to 1 year after the Second Operation (FMT)

• Myelin Thickness

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

• Nerve Fibre Diameter

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

Study Arms (2)

Electrical Stimulation

EXPERIMENTAL

Electrical Stimulation The patient will receive active electrical stimulation.

Device: Electrical Stimulation

Sham Treatment

PLACEBO COMPARATOR

No Electrical Stimulation The patient will receive sham electrical stimulation.

Device: Sham Treatment

Interventions

Electrical Stimulation 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.

Electrical Stimulation

Sham Treatment 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.

Sham Treatment

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Facial Paralysis; Bell Palsy

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Facial Nerve Diseases; Cranial Nerve Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Kristen Davidge, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

• Ronald Zuker, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 24, 2019
• Study Start: September 16, 2019
• Primary Completion: October 3, 2022
• Study Completion: October 3, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Locations

CA (1)