Functional Electrical Stimulation for Facial Muscles | NCT04457492

NCT04457492

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acute Facial Nerve Injury with Intact Facial Nerve	Experimental	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
Facial Nerve Grafting After Surgical Excision	Experimental	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
Standard of Care Group	No Intervention	No FES Assessments will be taken at the same intervals as the interventions group.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Application of FES to the Face	Other	Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated.	Acute Facial Nerve Injury with Intact Facial Nerve

Outcomes Module

Primary Outcomes

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

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Douglas Chepeha, MD	University Health Network, Toronto	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University Health Network		Toronto	Ontario	M5G 2C4	Canada

Condition Browse Module