Bell Palsy Clinical Trial
Official title:
Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury - A Randomized Controlled Prospective Study
Verified date | February 2023 |
Source | The Hospital for Sick Children |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | The Hospital for Sick Children | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children | The Physicians' Services Incorporated Foundation |
Canada,
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 |
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