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Electrical Stimulation to Promote Recovery in Bells Palsy

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ClinicalTrials.gov Identifier: NCT03836989
Recruitment Status : Terminated (Lack of enrollment)
First Posted : February 11, 2019
Results First Posted : May 11, 2021
Last Update Posted : May 11, 2021
Sponsor:
Information provided by (Responsible Party):
Myriam Loyo, Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE November 19, 2018
First Posted Date  ICMJE February 11, 2019
Results First Submitted Date  ICMJE January 15, 2021
Results First Posted Date  ICMJE May 11, 2021
Last Update Posted Date May 11, 2021
Actual Study Start Date  ICMJE January 22, 2018
Actual Primary Completion Date March 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
Recovery at 3 Months as Measured From Facial Photos With Different Facial Expressions [ Time Frame: 3 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2019)
Recovery at three months as measured from facial photos with different facial expressions [ Time Frame: three months ]
recovery
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2021)
  • House Brackmann Scale [ Time Frame: Baseline, and 3 months ]
    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) [ Time Frame: Baseline, 3 months and 6 months ]
    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 [ Time Frame: Baseline, 3 months and 6 months ]
    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 [ Time Frame: Baseline and in 3 months ]
    Measuring brow elevation using the MEEI FACE-gram program reported as the millimeters in decreased elevation in comparison to the unaffected side
  • Eye Closure [ Time Frame: Baseline and 3 months ]
    Measuring in millimeters of the eyelids remaining open during maximal eye closure using the MEEI FACE-gram program
  • Smile Excursion [ Time Frame: Baseline and 3 months ]
    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 [ Time Frame: Baseline and 3 months ]
    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 [ Time Frame: Baseline and 3 months ]
    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 [ Time Frame: 3 months ]
    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 [ Time Frame: 3 months ]
    Percentage of subjected who reported full adherence, partial adherence and non-adherence confirmed by comparing to the daily diary of use.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2019)
  • Patient reported quality of life in relation to facial paralysis measured by FaCE scale [ Time Frame: Monthly for 3 months ]
    Facial Clinimetric Evaluation (FaCE) Scale.
  • Patient reported quality of life in relation to facial synkinesis measured by SAQ scale [ Time Frame: Monthly for 3 months ]
    Synkinesis Assessment Questionnaire (SAQ)
  • Patient reported global quality of life [ Time Frame: Monthly for 3 months ]
    Short form 12 Health-related quality of life
  • Objective measurements of facial symmetry [ Time Frame: Monthly for 3 months ]
    Measuring palpebral fissure width, nasolabial fold symmetry, brow elevation, and oral commissure elevation ( combined to create total facial symmetry score)
  • Smile excursion [ Time Frame: Monthly for 3 months ]
    Emotrics software will be used to measure smile excursion
  • Smile excursion [ Time Frame: Monthly for 3 months ]
    Emotrics software will be used to measure smile excursion based on patient photographs
  • Facial symmetry at rest [ Time Frame: Monthly for 3 months ]
    Measured by facial asymmetry index (FAI) in photos
  • Facial symmetry during smile [ Time Frame: Monthly for 3 months ]
    Measured by facial asymmetry index (FAI) in photos
  • Patient tolerability [ Time Frame: 3 months ]
    questionnaire designed by research team
  • Use and compliance [ Time Frame: Monthly for 3 months ]
    Diary of use
  • Adverse effects [ Time Frame: Monthly for 3 months ]
    Patient reported
  • Eligibility [ Time Frame: 1 year ]
    We will keep records of how many patients meet eligibility criteria
  • Recruitment [ Time Frame: 1 year ]
    We will keep records of how many patients who meet eligibility criteria choose to participate
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electrical Stimulation to Promote Recovery in Bells Palsy
Official Title  ICMJE Pilot Clinical Trial to Study Facial Electrical Stimulation to Promote Recovery in Patients With Bell's Palsy and Poor Prognostic Factors
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes 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.
Primary Purpose: Treatment
Condition  ICMJE Bell Palsy
Intervention  ICMJE Device: Electrical stimulation device (tens unit)
An electrical stimulation device with adjustable voltage. Useful for both Sensory and Subsensory
Study Arms  ICMJE
  • 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.

    Intervention: Device: Electrical stimulation device (tens unit)
  • 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.

    Intervention: Device: Electrical stimulation device (tens unit)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 15, 2021)
4
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2019)
20
Actual Study Completion Date  ICMJE August 31, 2020
Actual Primary Completion Date March 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03836989
Other Study ID Numbers  ICMJE 16901
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Myriam Loyo, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Myriam D Loyo, MD Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP