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Functional Electrical Stimulation for Facial Palsy

N/A
Waitlist Available
Led By Douglas Chepeha, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients experiencing unilateral facial nerve paralysis Brackmann 5/6 or 6/6.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at week 0, 7 and 14
Awards & highlights

Study Summary

This trial is to help people with facial paralysis caused by weak facial muscles. The study uses electrical stimulation to help the muscles contract.

Who is the study for?
This trial is for individuals with severe unilateral facial nerve paralysis, specifically those rated Brackmann 5/6 or 6/6. It's not suitable for people with epilepsy or seizures, metal implants in the mouth, fibromyalgia, or those undergoing transcranial brain stimulation treatments.Check my eligibility
What is being tested?
The study tests Functional Electrical Stimulation (FES) on the face to help patients with facial nerve weakness contract their muscles and potentially improve facial expressions.See study design
What are the potential side effects?
While specific side effects are not listed here, FES may cause discomfort at the stimulation site, muscle fatigue after treatment, skin irritation under electrode pads and in rare cases could trigger a seizure if there's an underlying condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have severe paralysis on one side of my face.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at week 0, 7 and 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at week 0, 7 and 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change House-Brackmann Scale Measurement Over 14 weeks
Change in Elevation of Corner of Mouth Over 14 weeks
Change in Facial Movements Over 14 weeks
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Facial Nerve Grafting After Surgical ExcisionExperimental Treatment1 Intervention
40 sessions of FES (in a 14 week period) Assessments will be taken during the beginning, middle, and end of each study arm.
Group II: Acute Facial Nerve Injury with Intact Facial NerveExperimental Treatment1 Intervention
40 sessions of FES (in a 14 week period) Assessments will be taken during the beginning, middle, and end of each study arm.
Group III: Standard of Care GroupActive Control1 Intervention
No FES Assessments will be taken at the same intervals as the interventions group.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,472 Previous Clinical Trials
484,992 Total Patients Enrolled
Douglas Chepeha, MDPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
34 Total Patients Enrolled

Media Library

Functional Electrical Stimulation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04457492 — N/A
Facial Palsy Research Study Groups: Acute Facial Nerve Injury with Intact Facial Nerve, Facial Nerve Grafting After Surgical Excision, Standard of Care Group
Facial Palsy Clinical Trial 2023: Functional Electrical Stimulation Highlights & Side Effects. Trial Name: NCT04457492 — N/A
Functional Electrical Stimulation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04457492 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this particular clinical trial still accepting participants?

"Affirmative. Information found on clinicaltrials.gov confirms that this healthcare study, which was initially posted 11th November 2021, is still actively looking for participants. A total of 20 people need to be recruited from one facility."

Answered by AI

How many individuals have been enlisted in this clinical experiment?

"Affirmative. Information from clinicaltrials.gov indicates that this study, which was initiated on the 1st of November 2021, is actively recruiting volunteers. Specifically, 20 patients are needed at one medical facility."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
How old are they?
18 - 65
What site did they apply to?
University Health Network
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Functional Electrical Stimulation for Facial Muscles
2021. "Functional Electrical Stimulation for Facial Muscles". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04457492.
~0 spots leftby Apr 2025
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