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Device

Electrical Stimulation for Bell's Palsy

N/A
Waitlist Available
Led By Kristen Davidge, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing unilateral facial reanimation with a two-stage cross-face nerve graft and free gracilis muscle flap transfer who have;
i) isolated unilateral facial nerve palsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline (pre-op) over 2 years
Awards & highlights

Study Summary

This study is evaluating whether electrical stimulation of nerves can improve recovery of facial muscles in patients with facial palsy.

Eligible Conditions
  • Bell's Palsy

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline (pre-op) over 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (pre-op) over 2 years 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 in Myelinated Axon Count
Change in Pre-Operative Lip Excursion with Smile
Secondary outcome measures
Change in Facial Symmetry
Facial Clinimetric Evaluation (FaCE) Scores
Myelin Thickness
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Electrical StimulationExperimental Treatment1 Intervention
Electrical Stimulation The patient will receive active electrical stimulation.
Group II: Sham TreatmentPlacebo Group1 Intervention
No Electrical Stimulation The patient will receive sham electrical stimulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electrical Stimulation
2013
Completed Phase 2
~400

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
682 Previous Clinical Trials
6,945,327 Total Patients Enrolled
The Physicians' Services Incorporated FoundationOTHER
162 Previous Clinical Trials
26,748 Total Patients Enrolled
Kristen Davidge, MDPrincipal InvestigatorThe Hospital for Sick Children

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby Mar 2025