Bell PalsyNCT03836989
Electrical Stimulation to Promote Recovery in Bells Palsy
A study testing Electrical stimulation device (tens unit) in people with Bell Palsy, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bell Palsy
- What is being tested?
- Electrical stimulation device (tens unit)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2018to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Pilot Clinical Trial to Study Facial Electrical Stimulation to Promote Recovery in Patients With Bell's Palsy and Poor Prognostic Factors
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.
Read the 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.
- Conditions
- Bell Palsy
- Being tested
- Electrical stimulation device (tens unit)
- Keywords
- Facial Paralysis, Bell Palsy, Electrical Stimulation
- Medical subject headings
- Bell Palsy, Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulation device (tens unit)Device
An electrical stimulation device with adjustable voltage. Useful for both Sensory and Subsensory
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Electrical stimulation device (tens unit) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (10)
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)
Measured: Baseline, and 3 months
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).
Measured: Baseline, 3 months and 6 months
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.
Measured: Baseline, 3 months and 6 months
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
Measured: Baseline and in 3 months
Eye Closure
Measuring in millimeters of the eyelids remaining open during maximal eye closure using the MEEI FACE-gram program
Measured: Baseline and 3 months
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
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start22 Jan 2018
- Primary completion21 Mar 2019
- Study completion31 Aug 2020
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bell PalsyStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myriam Loyo, Oregon Health and Science University
- Investigators
- Myriam D Loyo, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836989
- Sponsor's protocol ID
- 16901
- Status last verified
- May 2021
- First submitted
- 19 Nov 2018
- Last updated
- 11 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Trial to Study Facial Electrical Stimulation to Promote Recovery in Patients With Bell's Palsy and Poor Prognostic Factors
- ClinicalTrials.gov ID
- NCT03836989
- Acronym / sponsor ID
- 16901
- Conditions
- Bell Palsy
- Keywords
- Facial Paralysis, Bell Palsy, Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 21 Mar 2019 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Posted 11 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-volt electrical stimulation | Experimental | Device: Electrical stimulation device (tens unit)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. |
| Subsensory electrical stimulation | Placebo comparator | Device: Electrical stimulation device (tens unit)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical stimulation device (tens unit)An electrical stimulation device with adjustable voltage. Useful for both Sensory and Subsensory | Device | High-volt electrical stimulation, Subsensory electrical stimulation |
Primary outcome
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.
10 secondary outcomes
House Brackmann Scale
Time frame: Baseline, and 3 months
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
Patient Reported Global Quality of Life Specific to Facial Paralysis
Time frame: Baseline, 3 months and 6 months
Objective Measurements of Brow Elevation
Time frame: Baseline and in 3 months
Eye Closure
Time frame: Baseline and 3 months
Smile Excursion
Time frame: Baseline and 3 months
Facial Symmetry at Rest
Time frame: Baseline and 3 months
Facial Symmetry During Smile
Time frame: Baseline and 3 months
Patient Tolerability
Time frame: 3 months
Self Reported Subject Adherence
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myriam D Loyo, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation device (tens unit) in people with Bell Palsy, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery at 3 Months as Measured From Facial Photos With Different Facial Expressions (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.