Electrical Stimulation to Promote Recovery in Bells Palsy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Clinical Trial to Study Facial Electrical Stimulation to Promote Recovery in Patients With Bell's Palsy and Poor Prognostic Factors

Conditions
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Bell Palsy

Intervention / Treatment
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* Device: Electrical stimulation device (tens unit)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-volt electrical stimulation<br>Plan to use a monophasic waveform having 100µmsec pulse duration, at 35 Hz using tolerated voltage to generate a contraction a total of 20 minutes. The stimulation will have 10 seconds on time, 30 seconds off time and 2 second ramp up and down. Electrical stimulation will be produced with the Orthostim 3 device (VQ Ortho Care). The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral mastoid region. Four facial muscles will be stimulated: 1)frontalis, 2) orbicularis oculi, 3) zygomaticus major, and 4) orbicularis oris. The voltage is turned up by the participant until he or she can see twitches or as high as tolerated. Ten contractions in each muscle group will be performed or 5 minutes per muscle if no contraction is achieved. | Device: Electrical stimulation device (tens unit)<br>* An electrical stimulation device with adjustable voltage. Useful for both Sensory and Subsensory<br>|
| Placebo Comparator: Subsensory electrical stimulation<br>Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current. The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting. | Device: Electrical stimulation device (tens unit)<br>* An electrical stimulation device with adjustable voltage. Useful for both Sensory and Subsensory<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery at 3 Months as Measured From Facial Photos With Different Facial Expressions | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| House Brackmann Scale | Determined by three blinded otolaryngologist reviewing facial photos of patients with smile and eye closure. Reported as an average of the three scores. The scales ranges from 1 (normal) to 6 (most severe dysfunction) | Baseline, and 3 months | 
| Patient Reported Quality of Life in Relation to Facial Synkinesis Measured by the Synkinesis Assessment Questionnaire (SAQ) | Quality of life is in part measured in this study using the patient reported Synkinesis Assessment Questionnaire (SAQ). The instrument consisting of 10 items asks participants how difficult certain facial activities are. Based on the average score for each domain the test gives a score between 20 (no synkinesis) to 100 (severe synkinesis, all the time). | Baseline, 3 months and 6 months | 
| Patient Reported Global Quality of Life Specific to Facial Paralysis | Measured by the validated quality of life patient reported questionnaire Facial Clinimetric Evaluation (FaCE) Scale with a scale from 0 (normal) to 100 (severe dysfunction). The scale encompasses facial movement, facial comfort, oral function, eye comfort, lacrimal control, and social function. | Baseline, 3 months and 6 months | 
| Objective Measurements of Brow Elevation | Measuring brow elevation using the MEEI FACE-gram program reported as the millimeters in decreased elevation in comparison to the unaffected side | Baseline and in 3 months | 
| Eye Closure | Measuring in millimeters of the eyelids remaining open during maximal eye closure using the MEEI FACE-gram program | Baseline and 3 months | 
| Smile Excursion | Measuring oral commissure exclusion using the MEEI FACE-gram program reported as the change in millimeters in the distance between the midline of the lower lip and the oral commissure in comparison between rest and smile | Baseline and 3 months | 
| Facial Symmetry at Rest | Measured by facial asymmetry index (FAI) at rest in photos which is calculated as the difference in the distance from the lateral canthus to the oral commissure between the affected and unaffected side. In the scale 0 equals no difference between sides and perfect symmetry. The closer a number is to 0, the higher the symmetry is. Ranges have not been published for this scale. FAI does not have a maximum score. | Baseline and 3 months | 
| Facial Symmetry During Smile | Measured by facial asymmetry index (FAI) during smile in photos which is calculated as the difference in the distance from the lateral canthus to the oral commissure between the affected and unaffected side. In the scale 0 equals perfect symmetry and no difference in sides. The closer a number is to 0, the greater the symmetry. Ranges have not been published for this scale. FAI does not have a maximum score. | Baseline and 3 months | 
| Patient Tolerability | Measured by a visual analog scale (VAS) which ranged from 0 to 10 where 0 stands for completely comfortable and 10 to very uncomfortable. A questionnaire designed by research team using a Likert's scale was created to measure patient tolerability. | 3 months | 
| Self Reported Subject Adherence | Percentage of subjected who reported full adherence, partial adherence and non-adherence confirmed by comparing to the daily diary of use. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Facial Paralysis, Bell Palsy, Electrical Stimulation