Functional Electrical Stimulation for Facial Muscles
- Conditions
- Facial Nerve Paresis
- Interventions
- Other: Application of FES to the Face
- Registration Number
- NCT04457492
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
- Patients experiencing unilateral facial nerve paralysis Brackmann 5/6 or 6/6.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acute Facial Nerve Injury with Intact Facial Nerve Application of FES to the Face 40 sessions of FES (in a 14 week period) Assessments will be taken during the beginning, middle, and end of each study arm. Facial Nerve Grafting After Surgical Excision Application of FES to the Face 40 sessions of FES (in a 14 week period) Assessments will be taken during the beginning, middle, and end of each study arm.
- Primary Outcome Measures
Name Time Method Change in Elevation of Corner of Mouth Over 14 weeks Measured at week 0, 7 and 14 Change in ability to raise corner of mouth, measured in mm
FaCE Questionnaire Administered at week 0, 7 and 14 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.
Change in Lagophthalmos Over 14 weeks Measured at week 0, 7 and 14 Change in ability to close eyelids, measured in mm
Change House-Brackmann Scale Measurement Over 14 weeks Measured at week 0, 7 and 14 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.
Change in Facial Movements Over 14 weeks Measured at week 0, 7 and 14 A video will be taken of the patient undergoing standard facial movements
Study Interview Administered at week 0, 7 and 14 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Health Network
🇨🇦Toronto, Ontario, Canada