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Functional Electrical Stimulation for Facial Muscles

Applying Functional Electrical Stimulation to Facial Muscles After Acute Paralysis

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04457492
Enrollment
1
Registered
2020-07-07
Start date
2021-11-01
Completion date
2023-03-16
Last updated
2024-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Nerve Paresis

Keywords

Facial Nerve Paralysis, Functional Electrical Stimulation, Rehabilitation

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.

Interventions

OTHERApplication of FES to the Face

Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated.

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Change in Lagophthalmos Over 14 weeksMeasured at week 0, 7 and 14Change in ability to close eyelids, measured in mm
Change in Elevation of Corner of Mouth Over 14 weeksMeasured at week 0, 7 and 14Change in ability to raise corner of mouth, measured in mm
Change House-Brackmann Scale Measurement Over 14 weeksMeasured at week 0, 7 and 14The 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.
FaCE QuestionnaireAdministered at week 0, 7 and 14Patient-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 Facial Movements Over 14 weeksMeasured at week 0, 7 and 14A video will be taken of the patient undergoing standard facial movements
Study InterviewAdministered at week 0, 7 and 14A 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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026