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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Bell Palsy
Intervention Device: Electrical stimulation device (tens unit)
Enrollment 4
Recruitment Details  
Pre-assignment Details

Blocks were designed to account for predictors of recovery. There were four allocation blocks: 1) >60 age with complete paralysis, 2) > 60 age with incomplete paralysis, 3) <60 age with complete paralysis and < 15 days duration, or 4) <60 age with complete paralysis and >15 days duration.

The block size was 2 and the allocation was 1:1. All patients were randomly allocated to high-volt arm

Arm/Group Title High-volt Electrical Stimulation Subsensory Electrical Stimulation
Hide Arm/Group 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.

Period Title: Overall Study
Started 4 0
Subjects > 60 Years Old With Complete Paralysis 1 0
Subjects > 60 Years Old With Incomplete Paralysis 1 0
Subject < 60 Years Old + Complete Paralysis < 15 Days Duration 1 0
Subjects < 60 Years Old + Complete Paralysis > 15 Days 1 0
Completed 4 0
Not Completed 0 0
Arm/Group Title High-volt Electrical Stimulation Subsensory Electrical Stimulation Total
Hide Arm/Group 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.

Total of all reporting groups
Overall Number of Baseline Participants 4 0 4
Hide Baseline Analysis Population Description
Randomization led to no participants in the Subsensory arm.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 0 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  50.0%
2
  50.0%
>=65 years
2
  50.0%
2
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 0 participants 4 participants
Female
3
  75.0%
3
  75.0%
Male
1
  25.0%
1
  25.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants 0 participants 4 participants
4
 100.0%
4
 100.0%
1.Primary Outcome
Title Recovery at 3 Months as Measured From Facial Photos With Different Facial Expressions
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Randomization led to no Subsensory participants.
Arm/Group Title High-volt Electrical Stimulation Subsensory Electrical Stimulation
Hide Arm/Group Description:

Plan to use a monophasic waveform having 100µmsec pulse duration, 35 Hz and using tolerated voltage for a total of 20 minutes. Electrical stimulation will be produced with the Orthostim 3 device. The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral arm.

The voltage is turned up by the participant until he or she can see twitches or as high as tolerated.

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.

Overall Number of Participants Analyzed 4 0
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
2.Secondary Outcome
Title House Brackmann Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects underwent subsensory electrical stimulation
Arm/Group Title High-volt Electrical Stimulation Subsensory Electrical Stimulation
Hide Arm/Group 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.

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

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.

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

Overall Number of Participants Analyzed 4 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
3 months 2  (1.15)
Baseline 5.5  (1)
3.Secondary Outcome
Title Patient Reported Quality of Life in Relation to Facial Synkinesis Measured by the Synkinesis Assessment Questionnaire (SAQ)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
No research subjects participated in the subsensory electrical stimulation arm
Arm/Group Title High-volt Electrical Stimulation Subsensory Electrical Stimulation
Hide Arm/Group Description:

Plan to use a monophasic waveform having 100µmsec pulse duration, 35 Hz and using tolerated voltage for a total of 20 minutes. Electrical stimulation will be produced with the Orthostim 3 device. The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral arm.

The voltage is turned up by the participant until he or she can see twitches or as high as tolerated.

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.

Overall Number of Participants Analyzed 4 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
3 month outcome 27.5  (5.25)
6 month outcome 38.7  (23.5)
Baseline 31  (7.7)
4.Secondary Outcome
Title Patient Reported Global Quality of Life Specific to Facial Paralysis
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects were recruited for the subsensory arm
Arm/Group Title High-volt Electrical Stimulation Subsensory Electrical Stimulation
Hide Arm/Group Description:

Plan to use a monophasic waveform having 100µmsec pulse duration, 35 Hz and using tolerated voltage for a total of 20 minutes. Electrical stimulation will be produced with the Orthostim 3 device. The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral arm.

The voltage is turned up by the participant until he or she can see twitches or as high as tolerated.

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.

Overall Number of Participants Analyzed 4 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 37.5  (3.4)
3 months 51.25  (12.03)
6 months 51  (15)
5.Secondary Outcome
Title Objective Measurements of Brow Elevation
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects were allocated to the subsensory arm
Arm/Group Title High-volt Electrical Stimulation Subsensory Electrical Stimulation
Hide Arm/Group 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.

Overall Number of Participants Analyzed 4 0
Mean (Standard Deviation)
Unit of Measure: millimeters
Baseline 7.75  (2.2)
3 months 4.5  (5.2)
6.Secondary Outcome
Title Eye Closure
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects were allocated to the subsensory arm
Arm/Group Title High-volt Electrical Stimulation Subsensory Electrical Stimulation
Hide Arm/Group 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.

Overall Number of Participants Analyzed 4 0
Mean (Standard Deviation)
Unit of Measure: millimeters
Baseline 2.5  (3.1)
3 months 0.5  (0.6)
7.Secondary Outcome
Title Smile Excursion
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects were allocated to the subsensory arm
Arm/Group Title High-volt Electrical Stimulation Subsensory Electrical Stimulation
Hide Arm/Group 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.

Overall Number of Participants Analyzed 4 0
Mean (Standard Deviation)
Unit of Measure: millimeters
Baseline -1  (1.15)
3 months 4.5  (3.5)
8.Secondary Outcome
Title Facial Symmetry at Rest
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects were allocated to the subsensory arm
Arm/Group Title High-volt Electrical Stimulation Subsensory Electrical Stimulation
Hide Arm/Group 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.

Overall Number of Participants Analyzed 4 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 0.25  (0.2)
3 months 0.02  (0)
9.Secondary Outcome
Title Facial Symmetry During Smile
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
no subjects were allocated to the subsensory arm
Arm/Group Title High-volt Electrical Stimulation Subsensory Electrical Stimulation
Hide Arm/Group 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.

Overall Number of Participants Analyzed 4 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 0.4  (0.6)
3 months 0.2  (0.19)
10.Secondary Outcome
Title Patient Tolerability
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
No subjected were recruited for the subsensory arm
Arm/Group Title High-volt Electrical Stimulation Subsensory Electrical Stimulation
Hide Arm/Group 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.

Overall Number of Participants Analyzed 4 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.7  (2.3)
11.Secondary Outcome
Title Self Reported Subject Adherence
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
no subjects were recruited to the subsensory electrical stimulation
Arm/Group Title High-volt Electrical Stimulation Subsensory Electrical Stimulation
Hide Arm/Group 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.

Overall Number of Participants Analyzed 4 0
Measure Type: Count of Participants
Unit of Measure: Participants
Full adherence
4
 100.0%
Partial adherence
0
   0.0%
Non adherence
0
   0.0%
Time Frame Adverse event data will be collected throughout the participants therapy. Therapy is to start during the first week of onset of facial paralysis and be used daily for three months or sooner until complete recovery is achieved. Adverse event data was collected for up to 3 months
Adverse Event Reporting Description No participants were enrolled in the subsensory stimulation.
 
Arm/Group Title High-volt Electric Stimulation Subsensory Electric Stimulation
Hide Arm/Group 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.

All-Cause Mortality
High-volt Electric Stimulation Subsensory Electric Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/0    
Hide Serious Adverse Events
High-volt Electric Stimulation Subsensory Electric Stimulation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/0    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High-volt Electric Stimulation Subsensory Electric Stimulation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/4 (75.00%)      0/0    
Nervous system disorders     
Pain   1/4 (25.00%)  1 0/0 
Headache   1/4 (25.00%)  0/0 
Skin and subcutaneous tissue disorders     
Skin irritation   1/4 (25.00%)  0/0 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Myriam Loyo
Organization: Oregon Health and Science University
Phone: 503-494-8510
EMail: loyo@ohsu.edu
Layout table for additonal information
Responsible Party: Myriam Loyo, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03836989    
Other Study ID Numbers: 16901
First Submitted: November 19, 2018
First Posted: February 11, 2019
Results First Submitted: January 15, 2021
Results First Posted: May 11, 2021
Last Update Posted: May 11, 2021