Electrical Stimulation to Promote Recovery in Bells Palsy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-22

Study Completion Date

2020-08-31

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.

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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.

Conditions

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Bell Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Investigator and outcome assessors are blinded to the intervention. The physical therapist that teaches the research subjects how to perform the interventions are not blinded and patients are told they are assigned to either sensory or subsensory protocols.

Study Groups

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High-volt electrical stimulation

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 Type EXPERIMENTAL

Electrical stimulation device (tens unit)

Intervention Type DEVICE

An electrical stimulation device with adjustable voltage. Useful for both Sensory and Subsensory

Subsensory electrical stimulation

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.

Group Type PLACEBO_COMPARATOR

Electrical stimulation device (tens unit)

Intervention Type DEVICE

An electrical stimulation device with adjustable voltage. Useful for both Sensory and Subsensory

Interventions

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Electrical stimulation device (tens unit)

An electrical stimulation device with adjustable voltage. Useful for both Sensory and Subsensory

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No