Electrical Stimulation to Promote Recovery in Bells Palsy

Oregon Health & Science University (OHSU)

Status: Terminated

Conditions: Bell Palsy

Treatments: Device: Electrical stimulation device (tens unit)

Study type: Interventional

Funder types: Other

Identifiers

NCT03836989

16901

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4 participants in 2 patient groups, including a placebo group

High-volt electrical stimulation

Experimental group

Description:

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.

Treatment:

Device: Electrical stimulation device (tens unit)

Subsensory electrical stimulation

Placebo Comparator group

Description:

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.

Treatment:

Device: Electrical stimulation device (tens unit)