Electrical Stimulation to Promote Recovery in Bells Palsy

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

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.

Study Overview

• Status: Terminated
• Conditions: Bell Palsy
• Intervention / Treatment: Device: Electrical stimulation device (tens unit)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Electrical stimulation device (tens unit); An electrical stimulation device with adjustable voltage. Useful for both Sensory and Subsensory
Placebo Comparator: 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.	Device: Electrical stimulation device (tens unit); An electrical stimulation device with adjustable voltage. Useful for both Sensory and Subsensory

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Myriam D Loyo, MD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Actual): March 21, 2019
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: February 8, 2019
• First Posted (Actual): February 11, 2019

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Electrical Stimulation; Bell Palsy; Facial Paralysis
• Additional Relevant MeSH Terms: Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Cranial Nerve Diseases; Herpesviridae Infections; Facial Nerve Diseases; Paralysis; Bell Palsy; Facial Paralysis
• Other Study ID Numbers: 16901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes