Functional Electrical Stimulation for Facial Muscles

NCT ID: NCT04457492

Last Updated: 2024-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-03-16

Brief Summary

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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.

Detailed Description

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Conditions

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Facial Nerve Paresis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Application of FES to the Face

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Application of FES to the Face

Intervention Type OTHER

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

Standard of Care Group

No FES

Assessments will be taken at the same intervals as the interventions group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Application of FES to the Face

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

Intervention Type OTHER

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Douglas Chepeha, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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19-5743

Identifier Type: -

Identifier Source: org_study_id

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