Electrical Stimulation to Promote Recovery in Bells Palsy

Bell Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03836989
• Other study ID #: 16901
• Status: Terminated
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: May 2021
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 31, 2020
• Est. primary completion date: March 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bell Palsy
• Facial Paralysis
• Paralysis

Intervention

Device:
• Electrical stimulation device (tens unit)
An electrical stimulation device with adjustable voltage. Useful for both Sensory and Subsensory

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Eye Closure	Measuring in millimeters of the eyelids remaining open during maximal eye closure using the MEEI FACE-gram program	Baseline and 3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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