Pilot Clinical Trial to Study Facial Electrical Stimulation to Promote Recovery in Patients With Bell's Palsy and Poor Prognostic Factors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bell Palsy
- Sponsor
- Oregon Health and Science University
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Recovery at 3 Months as Measured From Facial Photos With Different Facial Expressions
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
A feasibility pilot study to exam the necessary methodology for conducting a larger clinical trial for Bell's Palsy patients with a poor prognosis and the use of electrical stimulation.
Detailed Description
Here we describe a protocol for a prospective, randomized, double-blinded study to evaluate the effects of monophasic pulsed current ES on patients with Bell's palsy and factors predicting poor recovery, with a 6 month follow up. Motor level stimulation with a pulse duration of 100 μsec and a frequency of 35 pulses per second were chosen from focus group with physical therapist to treat facial paralysis and are consistent with clinical trials showing motor benefit after capel tunnel surgery.
Investigators
Myriam Loyo
Assistant Professor
Oregon Health and Science University
Eligibility Criteria
Inclusion Criteria
- •New diagnosis of bell's palsy (diagnosed in the last 30 days)
- •IF younger than 60 years of age must have complete paralysis on one side of face or both
- •IF older than 60 years of age paralysis must be present but CAN be incomplete.
Exclusion Criteria
- •Paralysis associated with any of the fallowing: cancer, tumor, surgery, stroke, or trauma.
- •Younger than 60 years old with INCOMPLETE paralysis.
- •Non English speakers
- •Pacemaker or deep brain stimulator
Outcomes
Primary Outcomes
Recovery at 3 Months as Measured From Facial Photos With Different Facial Expressions
Time Frame: 3 months
To evaluate for complete recovery, standardized photos of patients at rest, and during movement, will be evaluated by three treatment-blinded otolaryngologists. Total number of patients fully recovered over number of participants will be reported.
Secondary Outcomes
- Eye Closure(Baseline and 3 months)
- Smile Excursion(Baseline and 3 months)
- Patient Reported Global Quality of Life Specific to Facial Paralysis(Baseline, 3 months and 6 months)
- Self Reported Subject Adherence(3 months)
- House Brackmann Scale(Baseline, and 3 months)
- Patient Reported Quality of Life in Relation to Facial Synkinesis Measured by the Synkinesis Assessment Questionnaire (SAQ)(Baseline, 3 months and 6 months)
- Objective Measurements of Brow Elevation(Baseline and in 3 months)
- Facial Symmetry During Smile(Baseline and 3 months)
- Facial Symmetry at Rest(Baseline and 3 months)
- Patient Tolerability(3 months)