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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
7
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.
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.
The Hospital for Sick Children
Toronto, Ontario, Canada
Change in Pre-Operative Lip Excursion with Smile
FACEGRAM will be used to objectively analyse change in commissure excursion.
Time frame: 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.
Time frame: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later
Change in Facial Symmetry
FACEGRAM will be used to objectively analyse smile symmetry.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later
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