Facial ParalysisBioniceyeNCT04153916
Artificial Eye Blinking Stimulation Following Paralysis of the Facial Nerve
A study testing Neurotrigger eye blinking stimulator in people with Facial Paralysis and Bell Palsy, run by Neurotrigger Ltd at 1 site in Israel.
Trial summary
Artificial eye blinking stimulation following damage to the facial nerve. Group 1 - Patients with a persistent unilateral facial paralysis (palsy) that underwent an operation for facial reanimation Group 2 - Patients with temporary unilateral facial paralysis, secondary to unilateral Bell's palsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Paralysis, Bell Palsy
- What is being tested?
- Neurotrigger eye blinking stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2020to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients who meet ALL of the following criteria will be eligible for enrollment into this study:
- All patients
- Male or female above 18 years of age inclusive
- All patients will have to agree to provide a written informed consent, Fully understand all elements of and actually sign and date the written Institutional Review Board (IRB) approved informed consent before initiation of protocol-specified procedures;
- Willing to provide medical and demographic records of their facial paralysis, the consequences of the paralysis and general medical history.
- Group 1:
Show all 12Show fewer
- 5. Patients who comply with the definition of continuous existing unilateral facial paralysis and who underwent an operation for facial reanimation at least one year prior to enrollment
- Group 2:
- 5. Patients who comply with the definition of temporary unilateral facial paralysis secondary to Bell's palsy up to 2 years from the event.
- Second Phase
- All initial inclusion criteria will be as in phase 1
- Enrollment will be dependent on having a partner willing and capable to offer the six days a week daily support in placing the Neurotrigger simulator and closing eye at night time for a period of 3 weeks.
Who cannot join
- Patients with chronic facial paralysis and secondary established damage to the eye occurring prior to enrollment, Who did not undergo facial reanimation surgery.
- Patients with psychiatric, addictive, or any other disorder that compromises ability to give genuine informed consent for participation in this study.
- Patients suffering from any skin condition that will prevent effective attachment of the electrodes, including but not limited to allergy to any of the components of the skin electrode.
- Woman who is pregnant (positive pregnancy test)
- Woman who is nursing
- Unwillingness or inability to follow the procedures outlined in the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Artificial eye blinking stimulation following damage to the facial nerve. Group 1 - Patients with a persistent unilateral facial paralysis (palsy) that underwent an operation for facial reanimation Group 2 - Patients with temporary unilateral facial paralysis, secondary to unilateral Bell's palsy.
Primary objective: To evaluate whether the Neurotigger device can elicit a complete or a partial eyelid closure of the affected eye.
Secondary objective: To optimize the location of the Neurotrigger's electrodes, and define the level of the pain generated, if any, during device implementation and stimulation, as well as the method for the personal adjustment of the precise pattern of stimulation (strength, intensity, other features) to achieve eye blinking for different patients.
Read the detailed description
The study will involve two groups:
Group 1: Patients with a continuous unilateral facial paralysis that underwent an operation for facial reanimation will be enrolled at least one year after the operation according to review of medical records of the Department of plastic surgery.
Group 2: Patients with temporary unilateral facial paralysis secondary to Bell's palsy as was identified in the admission to the Hospital Department of Plastic Surgery or to the Department of Ear, Nose and Throat.
After being identified eligible to participate in the study, the patients will be invited to join the study, sign on the written informed consent, and their demographic and medical history will be recorded.
Patients identified to belong to these study groups in other hospitals may join the study, after pre-evaluation and medical record analysis by the study Principle Investigator (PI)/Co-PI.
The study will be constructed in two phases:
Phase 1 - The first stage is composed of a one-time participation for about three hours. This feasibility stage involves:
- Verifying compliance of the patients with the research inclusion and exclusion criteria
- Completion of the study clinical report form (CRF) for this stage
- Placement of the single use mini-electrodes that will be adhered to the facial skin near the non-blinking eye and coupled to the Neurotrigger stimulator to elicit eyelid closure.
An initial report will then be issued to summarize the patient's experience of using the system in the first testing attempt to identify a complete or partial eye blinking.
Participants identified to respond to the stimulator at a partial or complete eye closure level, will be invited to continue to use the device for additional two hours in the hospital premises.
A summary meeting will then be held to issue a summary report covering the overall patient's experience of using the system throughout the testing period.
The purpose of this first stage is to examine the possibility of closing the patient eyelid completely or partially, optimize electrode position, and maximize the patient's comfort level.
A profile of system efficacy in generating eyelid closure will then be generated including the characterization of the stimulus pattern (intensity, frequency, etc.)
Phase 2: The purpose of this stage is to examine how a continued use of the device by the patient may improve outcomes, and reduce complications that are derived of the facial nerve paralysis
Participants may be enrolled to the second phase up to one year from the first phase visit
In this second stage the duration of the participation is about three weeks (six days a week) and includes daily use of the device for up to 10 hours a day. During nights the patient will continue is standard pattern of either eye closure or leaving the eye open, as the patient used to do prior to the study.
This stage will involve a patient with a partner that is designated to support the patient closely during the placement and adjustment of the system.
The patient and the partner will both obtain a detailed mutual training of placing the electrode and device, activating the device (partner) and its use (patient) to assure complete assistance and guidance in installing the system and its use.
Prior to starting this stage the patient will undergo eye examination and will complete a Patient Graded Instrument for Facial Nerve Paralysis - The FaCE Scale Questionnaire - to evaluate the life quality with the facial nerve paralysis (Laryngoscope. 2001 Mar;111(3):387-98.Validation of a patient-graded instrument for facial nerve paralysis: the FaCE scale. Kahn JB et al.)
Patients are provided with help desk number to answer questions and queries during the study period as needed.
They will get a clear guidance of the possibility to get support at home by experience system user or by phone-call or by videoconference (Skype or the like) by communicating with the experienced Sponsor's personnel who can help them adjust the electrode to the face and reducing discomfort.
In case of a skin rush or any skin discomfort, the patient will call the clinic and will be invited to medical examination and, if necessary, for treatment of a rush reducing and calming ointment and be advised of re-using the system.
Participants will make an intermediate evaluation at one and a half week and a final visit at three weeks.
The last visit will include eye examination to compare the eye functioning before and after Phase 2, and the completion of a FaCE Scale Questionnaire to evaluate potential improvement in life quality.
- Conditions
- Facial Paralysis, Bell Palsy
- Being tested
- Neurotrigger eye blinking stimulator
- Keywords
- Eye blinking, facial nerve paralysis, nano electrode
- Medical subject headings
- Facial Paralysis, Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurotrigger eye blinking stimulatorDevice
Phase 1 - The first stage is composed of a one-time participation for about three hours and involves:
- Verifying compliance of the patients with the research inclusion and exclusion criteria
- Completion of the study clinical report form (CRF) for this stage
- Placement of the single use mini-electrodes that will be adhered to the facial skin near the non-blinking eye and coupled to the Neurotrigger stimulator to elicit eyelid closure.
Participants may be enrolled to the second phase up to one year from the first phase visit In the second stage the duration of the participation is about three weeks (six days a week) and includes daily use of the device for up to 10 hours a day. During nights the patient will continue is standard pattern of either eye closure or leaving the eye open, as the patient used to do prior to the study.
This stage will involve a patient with a partner that is designated to support the patient closely during the placement and adjustment of the system
| Study group | Role | What they receive |
|---|---|---|
| Single use and continuous use | Other | Patients with a continuous unilateral facial paralysis that underwent an operation for facial reanimation will be enrolled at least one year after the operation according to review of medical records of the Department of plastic surgery.
Patients with temporary unilateral facial paralysis secondary to Bell's palsy as was identified in the admission to the Hospital Department of Plastic Surgery or to the Department of Ear, Nose and Throat. Receives: Device: Neurotrigger eye blinking stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyelid closure - Partial or complete closure
Partial or complete eye closure. The results will be detailed in a data table which will include details of the number of participants, affiliation to a research group and level of eyelid closure.
Measured: 3 hours
Secondary outcomes (1)
Stage 2 only - Improving quality of life - The measurement will be performed by filling out a Quality of Life Questionnaire.
Reducing dry eye effects. Dry eye effects will be measured by filling out a Quality of Life Questionnaire including questioning about the frequency of use of eye drops.
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Aug 2020
- Primary completion30 Aug 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial ParalysisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- elicit a complete or a partial eyelid closure \& To optimize the location of the Neurotrigger's electrodes, and define the level of the pain generated, if any, during device implementation and stimulation, as well as the method for the personal adjustment of the precise pattern of stimulation (strength, intensity, other features) to achieve eye blinking for different patients.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurotrigger Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tel Aviv Medical Center
- Responsible party
- Sponsor
- Investigators
- Eyal Gur, MD, Principal investigator, Chairman, Dep. Plastic Surgery, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153916
- Sponsor's protocol ID
- 0266-19-TLV
- Acronym
- Bioniceye
- Status last verified
- Sep 2021
- First submitted
- 27 Oct 2019
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The product is protected by PCT application number: PCT/IL2019/050819 Study results will be published in medical journals
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Eye Blinking Stimulation Following Paralysis of the Facial Nerve
- ClinicalTrials.gov ID
- NCT04153916
- Acronym / sponsor ID
- Bioniceye / 0266-19-TLV
- Conditions
- Facial Paralysis, Bell Palsy
- Keywords
- Eye blinking, facial nerve paralysis, nano electrode
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Neurotrigger LtdIndustry (pharma, biotech, devices)
- Collaborators
- Tel Aviv Medical Center
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Artificial eye blinking stimulation following damage to the facial nerve. Group 1 - Patients with a persistent unilateral facial paralysis (palsy) that underwent an operation for facial reanimation Group 2 - Patients with temporary unilateral facial paralysis, secondary to unilateral Bell's palsy.
Primary objective: To evaluate whether the Neurotigger device can elicit a complete or a partial eyelid closure of the affected eye.
Secondary objective: To optimize the location of the Neurotrigger's electrodes, and define the level of the pain generated, if any, during device implementation and stimulation, as well as the method for the personal adjustment of the precise pattern of stimulation (strength, intensity, other features) to achieve eye blinking for different patients.
Detailed description
The study will involve two groups:
Group 1: Patients with a continuous unilateral facial paralysis that underwent an operation for facial reanimation will be enrolled at least one year after the operation according to review of medical records of the Department of plastic surgery.
Group 2: Patients with temporary unilateral facial paralysis secondary to Bell's palsy as was identified in the admission to the Hospital Department of Plastic Surgery or to the Department of Ear, Nose and Throat.
After being identified eligible to participate in the study, the patients will be invited to join the study, sign on the written informed consent, and their demographic and medical history will be recorded.
Patients identified to belong to these study groups in other hospitals may join the study, after pre-evaluation and medical record analysis by the study Principle Investigator (PI)/Co-PI.
The study will be constructed in two phases:
Phase 1 - The first stage is composed of a one-time participation for about three hours. This feasibility stage involves:
- Verifying compliance of the patients with the research inclusion and exclusion criteria
- Completion of the study clinical report form (CRF) for this stage
- Placement of the single use mini-electrodes that will be adhered to the facial skin near the non-blinking eye and coupled to the Neurotrigger stimulator to elicit eyelid closure.
An initial report will then be issued to summarize the patient's experience of using the system in the first testing attempt to identify a complete or partial eye blinking.
Participants identified to respond to the stimulator at a partial or complete eye closure level, will be invited to continue to use the device for additional two hours in the hospital premises.
A summary meeting will then be held to issue a summary report covering the overall patient's experience of using the system throughout the testing period.
The purpose of this first stage is to examine the possibility of closing the patient eyelid completely or partially, optimize electrode position, and maximize the patient's comfort level.
A profile of system efficacy in generating eyelid closure will then be generated including the characterization of the stimulus pattern (intensity, frequency, etc.)
Phase 2: The purpose of this stage is to examine how a continued use of the device by the patient may improve outcomes, and reduce complications that are derived of the facial nerve paralysis
Participants may be enrolled to the second phase up to one year from the first phase visit
In this second stage the duration of the participation is about three weeks (six days a week) and includes daily use of the device for up to 10 hours a day. During nights the patient will continue is standard pattern of either eye closure or leaving the eye open, as the patient used to do prior to the study.
This stage will involve a patient with a partner that is designated to support the patient closely during the placement and adjustment of the system.
The patient and the partner will both obtain a detailed mutual training of placing the electrode and device, activating the device (partner) and its use (patient) to assure complete assistance and guidance in installing the system and its use.
Prior to starting this stage the patient will undergo eye examination and will complete a Patient Graded Instrument for Facial Nerve Paralysis - The FaCE Scale Questionnaire - to evaluate the life quality with the facial nerve paralysis (Laryngoscope. 2001 Mar;111(3):387-98.Validation of a patient-graded instrument for facial nerve paralysis: the FaCE scale. Kahn JB et al.)
Patients are provided with help desk number to answer questions and queries during the study period as needed.
They will get a clear guidance of the possibility to get support at home by experience system user or by phone-call or by videoconference (Skype or the like) by communicating with the experienced Sponsor's personnel who can help them adjust the electrode to the face and reducing discomfort.
In case of a skin rush or any skin discomfort, the patient will call the clinic and will be invited to medical examination and, if necessary, for treatment of a rush reducing and calming ointment and be advised of re-using the system.
Participants will make an intermediate evaluation at one and a half week and a final visit at three weeks.
The last visit will include eye examination to compare the eye functioning before and after Phase 2, and the completion of a FaCE Scale Questionnaire to evaluate potential improvement in life quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- elicit a complete or a partial eyelid closure \& To optimize the location of the Neurotrigger's electrodes, and define the level of the pain generated, if any, during device implementation and stimulation, as well as the method for the personal adjustment of the precise pattern of stimulation (strength, intensity, other features) to achieve eye blinking for different patients.
| Arm | Type | Receives |
|---|---|---|
| Single use and continuous use | Other | Device: Neurotrigger eye blinking stimulatorPatients with a continuous unilateral facial paralysis that underwent an operation for facial reanimation will be enrolled at least one year after the operation according to review of medical records of the Department of plastic surgery. Patients with temporary unilateral facial paralysis secondary to Bell's palsy as was identified in the admission to the Hospital Department of Plastic Surgery or to the Department of Ear, Nose and Throat. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients who meet ALL of the following criteria will be eligible for enrollment into this study:
- All patients
- Male or female above 18 years of age inclusive
- All patients will have to agree to provide a written informed consent, Fully understand all elements of and actually sign and date the written Institutional Review Board (IRB) approved informed consent before initiation of protocol-specified procedures;
- Willing to provide medical and demographic records of their facial paralysis, the consequences of the paralysis and general medical history.
Key exclusion criteria (6 listed)
- Patients with chronic facial paralysis and secondary established damage to the eye occurring prior to enrollment, Who did not undergo facial reanimation surgery.
- Patients with psychiatric, addictive, or any other disorder that compromises ability to give genuine informed consent for participation in this study.
- Patients suffering from any skin condition that will prevent effective attachment of the electrodes, including but not limited to allergy to any of the components of the skin electrode.
- Woman who is pregnant (positive pregnancy test)
- Woman who is nursing
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 |
|---|---|---|
| Neurotrigger eye blinking stimulatorPhase 1 - The first stage is composed of a one-time participation for about three hours and involves: 1. Verifying compliance of the patients with the research inclusion and exclusion criteria 2. Completion of the study clinical report form (CRF) for this stage 3. Placement of the single use mini-electrodes that will be adhered to the facial skin near the non-blinking eye and coupled to the Neurotrigger stimulator to elicit eyelid closure. Participants may be enrolled to the second phase up to one year from the first phase visit In the second stage the duration of the participation is about three weeks (six days a week) and includes daily use of the device for up to 10 hours a day. During nights the patient will continue is standard pattern of either eye closure or leaving the eye open, as the patient used to do prior to the study. This stage will involve a patient with a partner that is designated to support the patient closely during the placement and adjustment of the system | Device | Single use and continuous use |
Primary outcome
Eyelid closure - Partial or complete closure
Time frame: 3 hours
Partial or complete eye closure. The results will be detailed in a data table which will include details of the number of participants, affiliation to a research group and level of eyelid closure.
1 secondary outcome
Stage 2 only - Improving quality of life - The measurement will be performed by filling out a Quality of Life Questionnaire.
Time frame: three weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No. The product is protected by PCT application number: PCT/IL2019/050819 Study results will be published in medical journals
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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.
Eyal Gur, MD principal investigator
Chairman, Dep. Plastic Surgery, Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurotrigger eye blinking stimulator in people with Facial Paralysis and Bell Palsy, run by Neurotrigger Ltd at 1 site in Israel.
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 12 inclusion and 6 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: finished, as of the sponsor's last update on 21 Mar 2024. 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 Israel. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Eyelid closure - Partial or complete closure (time frame: 3 hours). 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 21 Mar 2024.