Bell's PalsyParalysisNCT06542289
Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
A study testing BlinkER device. in people with Bell's Palsy and Ramsay Hunt Syndrome, run by Neurotrigger Ltd at 1 site in United States.
Trial summary
Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy. Read more about this study
- Who is it for?
- Ages 22 to 120 years
- Conditions the study is for
- Bell's Palsy, Ramsay Hunt Syndrome, Lyme Disease
- What is being tested?
- BlinkER device.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 22 years of age or older
- Unilateral facial palsy due to any of the following: Bell's palsy, Ramsay Hunt syndrome, malignant or benign tumor resection, Lyme disease, cerebrovascular accident (hemorrhagic or ischemic), or trauma
- A deficit in eye closure during blinking, defined as a mean blink score ≤2.0 in the study eye on the scale by Mäkelä, et al, as graded by the investigator.
- Willing and able to comply with the study procedures and follow-up
- Willing and able to provide informed consent
- English, Spanish, or Hebrew, Arabic -speaking
- In a trial with the BlinkER System, the device produces blinks sufficient to cover the pupil in the study eye, defined as a mean grade ≥ 3.0 on the Mäkelä scale, as graded by the investigator.
- Participant successfully completes BlinkER System training and certification
Who cannot join
- Bilateral facial paralysis (for example Parkinson's Disease)
- History of prior intervention that is providing closure of the eyelids (e.g., facial reanimation, complete tarsorrhaphy surgery, etc.)
- Has an implanted eyelid weight in the study eyelid.
- History of diabetic neuropathy, unstable cardiovascular disease, neurologic disease causing severe cognitive or motor impairment, severe immunological deficiency, or malignant diseases that are not in remission
- Signs of corneal infection, severe ocular surface inflammation, or significant periorbital skin inflammation/infection
- Suspected or diagnosed epilepsy.
Show all 15Show fewer
- Cancerous lesions in the area where the BlinkER system electrodes will be applied.
- Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
- Cornea or iris abnormalities that preclude visualization of the pupil
- Cranial nerve V palsy or neurotrophic keratitis
- Synkinesis that results in eyelid closure
- Known allergy to any of the patient-contacting materials of the BlinkeER electrode (i.e. polyethylene (PET) film tape or hydrogel)
- Participants who are pregnant or nursing.
- Participation in another ophthalmic clinical trial within one year prior to enrollment. Participant must also be willing to refrain from another ophthalmic study for the duration of the study.
- Co-existing condition, either ocular or non-ocular that, in the judgement of the investigator could affect the safety or effectiveness of treatment or the compliance of the participant to the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rand Eye Institute
Deerfield Beach, Florida, 33064
Alison Rand, MD, 954-782-1700, allisonrandmd@gmail.com
About this study
Official title: Single-Arm, Multicenter Study to Evaluate the Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.
Read the detailed description
A single-arm, multicenter study will be conducted to evaluate the safety and effectiveness of the Blinker system in achieving eyelid closure over a 3-month period in individuals with facial nerve palsy. The study aims to enroll at least 80 participants for evaluation. Participants will use the investigative device for a duration of 3 months.
All subjects will undergo the following visits: Screening/Baseline (Day 0), Day 1, Week 1, Week 2, Month 1, Month 2 (Remote visit), and Month 3.
The inclusion criteria for participants will be unilateral facial palsy due to conditions such as Bell's palsy, Ramsay Hunt syndrome, malignant or benign tumor resection, Lyme disease, cerebrovascular accident (hemorrhagic or ischemic), or trauma.
The estimated total study duration is 12 months.
- Conditions
- Bell's Palsy, Ramsay Hunt Syndrome, Lyme Disease, Facial Palsy
- Being tested
- BlinkER device.
- Keywords
- BlinkER System, BlinkER
- Medical subject headings
- Bell Palsy, Herpes Zoster Oticus, Lyme Disease, Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinkER device.Device
Participants will use the BlinkER System for 8-16 hours daily (removed during sleep) at approximately 10 blinks/minute. The stimulation cycle will be ON and OFF to achieve the desired blink rate. Participants will receive training on device usage before starting the study.
| Study group | Role | What they receive |
|---|---|---|
| BlinkER system treatment | Experimental | A prospective single-arm multicenter pivotal study designed to evaluate the safety and effectiveness of the BlinkER System in achieving eyelid closure in participants with facial nerve palsy. Participants will receive the NeuroTrigger Basic System and use it for up to 3 months. Receives: Device: BlinkER device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent of participants who achieve eyelid closure graded by independent, masked graders at a reading center.
Eyelid closure is defined as a mean blink score as graded by the independent masked graders using the Mäkelä scale:
5- Complete eye closure 4- Nearly complete eye closure 3- Eyelid covers the pupil 2-Eyelid partially covers the pupil
1-Twitch 0- No movement
Measured: 2 weeks
Secondary outcomes (3)
Percent of participants who achieve eyelid closure in the study eye at 1 month.
Eyelid closure is defined as a mean blink score as graded by the independent masked graders using the Mäkelä scale:
5- Complete eye closure 4- Nearly complete eye closure 3- Eyelid covers the pupil 2-Eyelid partially covers the pupil
1-Twitch 0- No movement
Measured: up to 1 month
Percent of participants who achieve eyelid closure in the study eye at 3 months.
Eyelid closure is defined as a mean blink score as graded by the independent masked graders using the Mäkelä scale:
5- Complete eye closure 4- Nearly complete eye closure 3- Eyelid covers the pupil 2-Eyelid partially covers the pupil
1-Twitch 0- No movement
Measured: up to 3 months
safety outcome is the rate of adverse events through 3 months.
safety measures include IOP, BCVA, slit lamp biomicroscopy and non-mydriatic fundus findings, and VAS pain and discomfort questionnaire evaluated at the follow-up visits.
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 posted7 Aug 2024
- Study start1 Oct 2025 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bell's PalsyStudies 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
- A single-arm study for subjects diagnosed with facial nerve palsy.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurotrigger Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ran Ben Cnaan, MD, Principal investigator, Sourasky Medical Center - IchilovAlison Rand, MD, Principal investigator, Rand Eye InstituteJennifer Tan, MD, Principal investigator, Sheffield Teaching Hospital - Royal Hallamshire HospitalDavid Zadok, MD, Principal investigator, Shaarei Zedek MCBernard Chang, MD, Principal investigator, Leeds Teaching Hospital - St. James University HospitalReza Vagefi, MD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542289
- Sponsor's protocol ID
- NT-CLN-00200
- Acronym
- Paralysis
- Status last verified
- Nov 2024
- First submitted
- 22 Jul 2024
- Last updated
- 10 Jun 2025
- Results posted
- No
- 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 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Arm, Multicenter Study to Evaluate the Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
- ClinicalTrials.gov ID
- NCT06542289
- Acronym / sponsor ID
- Paralysis / NT-CLN-00200
- Conditions
- Bell's Palsy, Ramsay Hunt Syndrome, Lyme Disease, Facial Palsy
- Keywords
- BlinkER System, BlinkER
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Neurotrigger LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 7 Aug 2024 (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.
Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.
Detailed description
A single-arm, multicenter study will be conducted to evaluate the safety and effectiveness of the Blinker system in achieving eyelid closure over a 3-month period in individuals with facial nerve palsy. The study aims to enroll at least 80 participants for evaluation. Participants will use the investigative device for a duration of 3 months.
All subjects will undergo the following visits: Screening/Baseline (Day 0), Day 1, Week 1, Week 2, Month 1, Month 2 (Remote visit), and Month 3.
The inclusion criteria for participants will be unilateral facial palsy due to conditions such as Bell's palsy, Ramsay Hunt syndrome, malignant or benign tumor resection, Lyme disease, cerebrovascular accident (hemorrhagic or ischemic), or trauma.
The estimated total study duration is 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm study for subjects diagnosed with facial nerve palsy.
| Arm | Type | Receives |
|---|---|---|
| BlinkER system treatment | Experimental | Device: BlinkER device.A prospective single-arm multicenter pivotal study designed to evaluate the safety and effectiveness of the BlinkER System in achieving eyelid closure in participants with facial nerve palsy. Participants will receive the NeuroTrigger Basic System and use it for up to 3 months. |
Who may qualify
- Ages
- 22 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 22 years of age or older
- Unilateral facial palsy due to any of the following: Bell's palsy, Ramsay Hunt syndrome, malignant or benign tumor resection, Lyme disease, cerebrovascular accident (hemorrhagic or ischemic), or trauma
- A deficit in eye closure during blinking, defined as a mean blink score ≤2.0 in the study eye on the scale by Mäkelä, et al, as graded by the investigator.
- Willing and able to comply with the study procedures and follow-up
- Willing and able to provide informed consent
Key exclusion criteria (15 listed)
- Bilateral facial paralysis (for example Parkinson's Disease)
- History of prior intervention that is providing closure of the eyelids (e.g., facial reanimation, complete tarsorrhaphy surgery, etc.)
- Has an implanted eyelid weight in the study eyelid.
- History of diabetic neuropathy, unstable cardiovascular disease, neurologic disease causing severe cognitive or motor impairment, severe immunological deficiency, or malignant diseases that are not in remission
- Signs of corneal infection, severe ocular surface inflammation, or significant periorbital skin inflammation/infection
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 |
|---|---|---|
| BlinkER device.Participants will use the BlinkER System for 8-16 hours daily (removed during sleep) at approximately 10 blinks/minute. The stimulation cycle will be ON and OFF to achieve the desired blink rate. Participants will receive training on device usage before starting the study. | Device | BlinkER system treatment |
Primary outcome
The percent of participants who achieve eyelid closure graded by independent, masked graders at a reading center.
Time frame: 2 weeks
Eyelid closure is defined as a mean blink score as graded by the independent masked graders using the Mäkelä scale: 5- Complete eye closure 4- Nearly complete eye closure 3- Eyelid covers the pupil 2-Eyelid partially covers the pupil 1-Twitch 0- No movement
3 secondary outcomes
Percent of participants who achieve eyelid closure in the study eye at 1 month.
Time frame: up to 1 month
Percent of participants who achieve eyelid closure in the study eye at 3 months.
Time frame: up to 3 months
safety outcome is the rate of adverse events through 3 months.
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Bell's Palsy
Not yet recruiting
Deep-plane Facelift As A Staged Adjunct To Facial Reanimation : Functional And Aesthetic Outcomes in Comparison to Facial Reanimation Alone
Facial Palsy
RecruitingPhase 3
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Vestibular Schwannoma, Facial Nerve Paralysis
Recruiting
Eye-Tracking FP "A Pilot Study of the Quantitative Evaluation of the Attention Paid to Faces With Facial Palsy by the Eye-tracking Technology.
Eye-tracking, Facial Palsy
Not yet recruiting
Mindfulness in Nonflaccid Facial Paralysis
Facial Paralysis
Recruiting
Treatment for "Asymmetric Crying Facies"
Hemifacial Microsomia, Facial Nerve Paralysis
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.
Ran Ben Cnaan, MD principal investigator
Sourasky Medical Center - Ichilov
Alison Rand, MD principal investigator
Rand Eye Institute
Jennifer Tan, MD principal investigator
Sheffield Teaching Hospital - Royal Hallamshire Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BlinkER device. in people with Bell's Palsy and Ramsay Hunt Syndrome, run by Neurotrigger Ltd 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 8 inclusion and 15 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: opening soon, as of the sponsor's last update on 10 Jun 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hila Kfir (+972-523313350, hila@nt-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percent of participants who achieve eyelid closure graded by independent, masked graders at a reading center. (time frame: 2 weeks). 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 10 Jun 2025.