Back to resultsFunctional Electrical Stimulation for Facial Muscles
Primary Purpose
Facial Nerve Paresis
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Application of FES to the Face
Sponsored by
About this trial
This is an interventional other trial for Facial Nerve Paresis focused on measuring Facial Nerve Paralysis, Functional Electrical Stimulation, Rehabilitation
Eligibility Criteria
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).
Sites / Locations
- University Health NetworkRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Acute Facial Nerve Injury with Intact Facial Nerve
Facial Nerve Grafting After Surgical Excision
Standard of Care Group
Arm Description
40 sessions of FES (in a 14 week period) Assessments will be taken during the beginning, middle, and end of each study arm.
40 sessions of FES (in a 14 week period) Assessments will be taken during the beginning, middle, and end of each study arm.
No FES Assessments will be taken at the same intervals as the interventions group.
Outcomes
Primary Outcome Measures
Change in Lagophthalmos Over 14 weeks
Change in ability to close eyelids, measured in mm
Change in Elevation of Corner of Mouth Over 14 weeks
Change in ability to raise corner of mouth, measured in mm
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.
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.
Change in Facial Movements Over 14 weeks
A video will be taken of the patient undergoing standard facial movements
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04457492
First Posted
June 8, 2020
Last Updated
April 19, 2022
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT04457492
Brief Title
Functional Electrical Stimulation for Facial Muscles
Official Title
Applying Functional Electrical Stimulation to Facial Muscles After Acute Paralysis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Nerve Paresis
Keywords
Facial Nerve Paralysis, Functional Electrical Stimulation, Rehabilitation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acute Facial Nerve Injury with Intact Facial Nerve
Arm Type
Experimental
Arm Description
40 sessions of FES (in a 14 week period)
Assessments will be taken during the beginning, middle, and end of each study arm.
Arm Title
Facial Nerve Grafting After Surgical Excision
Arm Type
Experimental
Arm Description
40 sessions of FES (in a 14 week period)
Assessments will be taken during the beginning, middle, and end of each study arm.
Arm Title
Standard of Care Group
Arm Type
No Intervention
Arm Description
No FES
Assessments will be taken at the same intervals as the interventions group.
Intervention Type
Other
Intervention Name(s)
Application of FES to the Face
Intervention Description
Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated.
Primary Outcome Measure Information:
Title
Change in Lagophthalmos Over 14 weeks
Description
Change in ability to close eyelids, measured in mm
Time Frame
Measured at week 0, 7 and 14
Title
Change in Elevation of Corner of Mouth Over 14 weeks
Description
Change in ability to raise corner of mouth, measured in mm
Time Frame
Measured at week 0, 7 and 14
Title
Change House-Brackmann Scale Measurement Over 14 weeks
Description
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.
Time Frame
Measured at week 0, 7 and 14
Title
FaCE Questionnaire
Description
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.
Time Frame
Administered at week 0, 7 and 14
Title
Change in Facial Movements Over 14 weeks
Description
A video will be taken of the patient undergoing standard facial movements
Time Frame
Measured at week 0, 7 and 14
Title
Study Interview
Description
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
Time Frame
Administered at week 0, 7 and 14
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alex Esemezie, BACYC
Phone
416-340-3082
Email
Alex.Esemezie@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Chepeha, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Esemezie, BACYC
Phone
416-340-3082
Email
alex.esemezie@uhn.ca
12. IPD Sharing Statement
Learn more about this trial
Functional Electrical Stimulation for Facial Muscles
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