Functional Electrical Stimulation for Facial Muscles

Not Applicable

Terminated

• Conditions: Facial Nerve Paresis

• 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

Study Timeline

• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-07
• Study Start: 2021-11-01
• Primary Completion: 2023-03-16
• Study Completion: 2023-03-16
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada