Electrical Stimulation to Promote Recovery in Bells Palsy

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Primary Purpose

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Electrical stimulation device (tens unit)

About this trial

This is an interventional treatment trial for Bell Palsy focused on measuring Facial Paralysis, Bell Palsy, Electrical Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Oregon Health and Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

High-volt electrical stimulation

Subsensory electrical stimulation

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

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).

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.

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

Eye Closure

Measuring in millimeters of the eyelids remaining open during maximal eye closure using the MEEI FACE-gram program

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

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.

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.

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.

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.

Full Information

NCT ID

NCT03836989

First Posted

November 19, 2018

Last Updated

May 7, 2021

Sponsor

Oregon Health and Science University

1. Study Identification

Unique Protocol Identification Number

NCT03836989

Brief Title

Electrical Stimulation to Promote Recovery in Bells Palsy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Terminated

Why Stopped

Lack of enrollment

Study Start Date

January 22, 2018 (Actual)

Primary Completion Date

March 21, 2019 (Actual)

Study Completion Date

August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oregon Health and Science University

4. Oversight

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

Data Monitoring Committee

No

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bell Palsy

Keywords

Facial Paralysis, Bell Palsy, Electrical Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-volt electrical stimulation

Arm Type

Experimental

Arm 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.

Arm Title

Subsensory electrical stimulation

Arm Type

Placebo Comparator

Arm 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.

Intervention Type

Device

Intervention Name(s)

Electrical stimulation device (tens unit)

Intervention Description

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

Primary Outcome Measure Information:

Title

Recovery at 3 Months as Measured From Facial Photos With Different Facial Expressions

Description

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 Outcome Measure Information:

Title

House Brackmann Scale

Description

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

Title

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

Description

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

Title

Patient Reported Global Quality of Life Specific to Facial Paralysis

Description

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

Title

Objective Measurements of Brow Elevation

Description

Measuring brow elevation using the MEEI FACE-gram program reported as the millimeters in decreased elevation in comparison to the unaffected side

Time Frame

Baseline and in 3 months

Title

Eye Closure

Description

Measuring in millimeters of the eyelids remaining open during maximal eye closure using the MEEI FACE-gram program

Time Frame

Baseline and 3 months

Title

Smile Excursion

Description

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

Time Frame

Baseline and 3 months

Title

Facial Symmetry at Rest

Description

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.

Time Frame

Baseline and 3 months

Title

Facial Symmetry During Smile

Description

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.

Time Frame

Baseline and 3 months

Title

Patient Tolerability

Description

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.

Time Frame

3 months

Title

Self Reported Subject Adherence

Description

Percentage of subjected who reported full adherence, partial adherence and non-adherence confirmed by comparing to the daily diary of use.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Myriam D Loyo, MD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

Bell Palsy

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial