Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury

Not Applicable

Terminated

• Conditions: Bell Palsy; Hemifacial Paralysis
• Interventions: Device: Sham Treatment; Device: Electrical Stimulation

• Registration Number: NCT03996525
• Lead Sponsor: The Hospital for Sick Children

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-20
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-24
• Study Start: 2019-09-16
• Primary Completion: 2022-10-03
• Study Completion: 2022-10-03
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Treatment	Sham Treatment	No Electrical Stimulation The patient will receive sham electrical stimulation.
Electrical Stimulation	Electrical Stimulation	Electrical Stimulation The patient will receive active electrical stimulation.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Facial Symmetry	Change from Baseline (Pre-Op) over 2 Years	FACEGRAM will be used to objectively analyse smile symmetry.
Nerve Fibre Diameter	Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later	Using histomorphometry, Nerve Fibre Diameter will be used as a surrogate measure for the rate of axon regeneration.
Myelin Thickness	Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later	Using histomorphometry, Myelin Thickness will be used as a surrogate measure for the rate of axon regeneration.
Myelin Thickness/Fibre Diameter Ratio	Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later	Using histomorphometry, Myelin Thickness/Fibre Diameter Ratio will be used as a surrogate measure for the rate of axon regeneration.
Facial Clinimetric Evaluation (FaCE) Scores	Change from Baseline (Pre-Op) Over 2 Years	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	Up to 1 year after the Second Operation (FMT)	Study participants are requested to monitor their facial movements and record any changes in a daily diary once they first notice facial movement.

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada