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
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.
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- 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