NCT04457492

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2023

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

June 8, 2020

Last Update Submit

March 18, 2024

Conditions

Facial Nerve Paresis

Keywords

Facial Nerve ParalysisFunctional Electrical StimulationRehabilitation

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (3)

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

Application of FES to the FaceOTHER

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

Acute Facial Nerve Injury with Intact Facial NerveFacial Nerve Grafting After Surgical Excision

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients experiencing unilateral facial nerve paralysis Brackmann 5/6 or 6/6.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Bell Palsy

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsMouth DiseasesStomatognathic DiseasesFacial Nerve DiseasesCranial Nerve DiseasesNervous System Diseases

Study Officials

  • Douglas Chepeha, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2020

First Posted

July 7, 2020

Study Start

November 1, 2021

Primary Completion

March 16, 2023

Study Completion

March 16, 2023

Last Updated

March 20, 2024

Record last verified: 2024-03

Locations

CA(1)