Functional Electrical Stimulation for Facial Muscles

Applying Functional Electrical Stimulation to Facial Muscles After Acute Paralysis

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.

Study Overview

• Status: Terminated
• Conditions: Facial Nerve Paresis
• Intervention / Treatment: Other: Application of FES to the Face

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alex Esemezie, BACYC; Phone Number: 416-340-3082; Email: alex.esemezie@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acute Facial Nerve Injury with Intact Facial Nerve; 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; Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated.
Experimental: Facial Nerve Grafting After Surgical Excision; 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; Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated.
No Intervention: Standard of Care Group; No FES Assessments will be taken at the same intervals as the interventions group.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Douglas Chepeha, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): March 16, 2023
• Study Completion (Actual): March 16, 2023

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Functional Electrical Stimulation; Facial Nerve Paralysis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease Attributes; Paresis; Facies
• Other Study ID Numbers: 19-5743

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No