Functional Electrical Stimulation for Facial Muscles

Study Overview
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Brief Summary
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Partial or complete facial paralysis is the weakness of muscles of facial expression. Facial paralysis causes physical, social and emotional problems. Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated, causing them to contract This study is designed to help patients with facial nerve weakness.

Official Title
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Applying Functional Electrical Stimulation to Facial Muscles After Acute Paralysis

Conditions
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Facial Nerve Paresis

Intervention / Treatment
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* Other: Application of FES to the Face


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients experiencing unilateral facial nerve paralysis Brackmann 5/6 or 6/6. Exclusion Criteria: History of epilepsy or seizures. Individuals with metal orthopedic implants in the mouth (e.g. plates or screws). Individuals suffering from fibromyalgia. Individuals currently receiving any form of transcranial brain stimulation (e.g. rTMS, ECT, or MST).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute Facial Nerve Injury with Intact Facial Nerve<br>40 sessions of FES (in a 14 week period) Assessments will be taken during the beginning, middle, and end of each study arm. | Other: Application of FES to the Face<br>* Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated.<br>|
| Experimental: Facial Nerve Grafting After Surgical Excision<br>40 sessions of FES (in a 14 week period) Assessments will be taken during the beginning, middle, and end of each study arm. | Other: Application of FES to the Face<br>* Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated.<br>|
| No Intervention: Standard of Care Group<br>No FES Assessments will be taken at the same intervals as the interventions group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lagophthalmos Over 14 weeks | Change in ability to close eyelids, measured in mm | Measured at week 0, 7 and 14 | 
| Change in Elevation of Corner of Mouth Over 14 weeks | Change in ability to raise corner of mouth, measured in mm | Measured at week 0, 7 and 14 | 
| Change House-Brackmann Scale Measurement Over 14 weeks | The House-Brackmann facial nerve grading scale is a measure of facial nerve impairment. The scale ranges from values 1 to 6, with larger values indicating greater facial nerve impairment. | Measured at week 0, 7 and 14 | 
| FaCE Questionnaire | Patient-based instrument to measure both facial impairment and disability. This will be used to identify patient's perceived change in facial impairment for the duration of the study period. | Administered at week 0, 7 and 14 | 
| Change in Facial Movements Over 14 weeks | A video will be taken of the patient undergoing standard facial movements | Measured at week 0, 7 and 14 | 
| Study Interview | A structured interview questionnaire administered by a study team member to identify any changes to the therapy that may be needed before further studies are conducted | Administered at week 0, 7 and 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Facial Nerve Paralysis, Functional Electrical Stimulation, Rehabilitation