Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury

Bell Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03996525
• Other study ID #: 1000063546
• Status: Terminated
• Phase: N/A
• Start date: September 16, 2019
• Est. completion date: October 3, 2022

Study information

• Verified date: February 2023
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: October 3, 2022
• Est. primary completion date: October 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Bell Palsy
• Facial Paralysis
• Hemifacial Paralysis
• Paralysis
• Peripheral Nerve Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Facial Symmetry	FACEGRAM will be used to objectively analyse smile symmetry.	Change from Baseline (Pre-Op) over 2 Years
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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