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Functional Electrical Stimulation for Facial Muscles

Not Applicable
Terminated
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
Inclusion Criteria
  • Patients experiencing unilateral facial nerve paralysis Brackmann 5/6 or 6/6.
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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).
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Acute Facial Nerve Injury with Intact Facial NerveApplication of FES to the Face40 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 ExcisionApplication of FES to the Face40 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
NameTimeMethod
Change in Elevation of Corner of Mouth Over 14 weeksMeasured at week 0, 7 and 14

Change in ability to raise corner of mouth, measured in mm

FaCE QuestionnaireAdministered 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 weeksMeasured at week 0, 7 and 14

Change in ability to close eyelids, measured in mm

Change House-Brackmann Scale Measurement Over 14 weeksMeasured 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 weeksMeasured at week 0, 7 and 14

A video will be taken of the patient undergoing standard facial movements

Study InterviewAdministered 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
NameTimeMethod

Trial Locations

Locations (1)

University Health Network

🇨🇦

Toronto, Ontario, Canada

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