Electrical Stimulation to Promote Recovery in Bells Palsy

NCT03836989 | Terminated Results FDA Device

• 1 other identifier: 16901
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bell Palsy

Keywords

Facial Paralysis; Bell Palsy; Electrical Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• House Brackmann Scale

  Baseline, and 3 months

• Patient Reported Quality of Life in Relation to Facial Synkinesis Measured by the Synkinesis Assessment Questionnaire (SAQ)

  Baseline, 3 months and 6 months

• Patient Reported Global Quality of Life Specific to Facial Paralysis

  Baseline, 3 months and 6 months

• Objective Measurements of Brow Elevation

  Baseline and in 3 months

• Eye Closure

  Baseline and 3 months

Study Arms (2)

High-volt electrical stimulation

EXPERIMENTAL

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)

Subsensory electrical stimulation

PLACEBO COMPARATOR

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)

Interventions

Electrical stimulation device (tens unit) DEVICE

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

High-volt electrical stimulation; Subsensory electrical stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Bell Palsy; Facial Paralysis

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Myriam Loyo
• Organization: Oregon Health and Science University

loyo@ohsu.edu

503-494-8510

Study Officials

• Myriam D Loyo, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: February 11, 2019
• Study Start: January 22, 2018
• Primary Completion: March 21, 2019
• Study Completion: August 31, 2020
• Last Updated: May 11, 2021
• Results First Posted: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)