Bell Palsy, Hemifacial Paralysis
Conditions
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
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.
Interventions
DEVICEElectrical Stimulation
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.
DEVICESham Treatment
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.
Sponsors
The Physicians' Services Incorporated Foundation
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Change in Facial Symmetry | Change from Baseline (Pre-Op) over 2 Years | FACEGRAM will be used to objectively analyse smile symmetry. |
| 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. |
| 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. |
| 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. |
Countries
Canada
Outcome results
None listed