Functional Electrical Stimulation for Facial Muscles

Facial Nerve Paresis Clinical Trial

Official title:

Applying Functional Electrical Stimulation to Facial Muscles After Acute Paralysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04457492
• Other study ID #: 19-5743
• Status: Terminated
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: March 16, 2023

Study information

• Verified date: March 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 16, 2023
• Est. primary completion date: March 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Facial Nerve Paresis
• Facies
• Paresis

Intervention

Other:
• Application of FES to the Face
Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Lagophthalmos Over 14 weeks	Change in ability to close eyelids, measured in mm	Measured at week 0, 7 and 14
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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