Functional Electrical Stimulation for Facial Muscles

University Health Network, Toronto

Status: Terminated

Conditions: Facial Nerve Paresis

Treatments: Other: Application of FES to the Face

Study type: Interventional

Funder types: Other

Identifiers

NCT04457492

19-5743

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 3 patient groups

Acute Facial Nerve Injury with Intact Facial Nerve

Experimental group

Description:

40 sessions of FES (in a 14 week period) Assessments will be taken during the beginning, middle, and end of each study arm.

Treatment:

Other: Application of FES to the Face

Facial Nerve Grafting After Surgical Excision

Experimental group

Description:

40 sessions of FES (in a 14 week period) Assessments will be taken during the beginning, middle, and end of each study arm.

Treatment:

Other: Application of FES to the Face

Standard of Care Group

No Intervention group

Description:

No FES Assessments will be taken at the same intervals as the interventions group.