Electrical Stimulation to Promote Recovery in Bells Palsy

Oregon Health and Science University4 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bell Palsy

Interventions

Electrical stimulation device (tens unit)DEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Oregon Health and Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

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)

Time frame: 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).

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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