Electrical Stimulation to Promote Recovery in Bells Palsy

N/A

Waitlist Available

Led By Myriam D Loyo, MD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months and 6 months

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.

Eligible Conditions

Bell's Palsy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recovery at 3 Months as Measured From Facial Photos With Different Facial Expressions

Secondary study objectives

Eye Closure

Facial Symmetry During Smile

Facial Symmetry at Rest

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: High-volt electrical stimulationExperimental Treatment1 Intervention

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.

Group II: Subsensory electrical stimulationPlacebo Group1 Intervention

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.

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