BlinkER Device for Facial Nerve Palsy

(Paralysis Trial)

Overseen By Nikolai Kunicher

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neurotrigger Ltd

Disqualifiers: Bilateral facial paralysis, Epilepsy, Unstable cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the BlinkER System, a device designed to help people with facial nerve palsy close their eyelids properly. The goal is to determine if this device is safe and effective for those who struggle to blink due to conditions like Bell's palsy or after certain surgeries or traumas. Participants must have difficulty closing one eye when blinking. This trial does not suit individuals with complete eyelid closure from previous treatments or bilateral facial paralysis. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance quality of life for many.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the BlinkER System is safe for participants with facial nerve palsy?

In a previous study, researchers tested the BlinkER System to determine if it could safely assist people with facial nerve palsy in closing their eyelids. Participants used the system for up to three months to evaluate its safety and effectiveness.

The research aimed to ensure the device did not cause harm. Although detailed data from these studies is unavailable, the device's progression to a larger trial suggests it was safe enough in earlier research to advance. This indicates it is likely well-tolerated, but all treatments can carry some risks. Researchers closely monitored participants' experiences and any side effects.

In summary, the BlinkER System has passed safety checks in earlier research, indicating it is generally safe. However, as with any trial, unknown risks might exist. Always consult a doctor to understand what joining the trial could mean. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for facial nerve palsy, like physical therapy or surgery, aim to restore nerve function or compensate for muscle weakness. The BlinkER System stands out because it uses a novel mechanism: it employs the NeuroTrigger Basic System to directly stimulate eyelid closure. This approach offers a non-invasive alternative that could provide more immediate results without the need for surgical intervention. Researchers are excited about its potential to improve quality of life by allowing patients to achieve natural, controlled eyelid movement over a short period, which current options may not offer.

What evidence suggests that the BlinkER system is effective for facial nerve palsy?

Research shows that the BlinkER System, which participants in this trial will receive, might help people with facial nerve palsy by improving eyelid closure. Studies have found that many patients experience relief from eye irritation after using similar devices. In one study, almost 80% of patients reported some relief from their symptoms. This suggests that the BlinkER System could effectively aid eyelid movement. The system supports the natural blinking process, often challenging for people with facial nerve palsy. Early signs indicate that it might help restore some normal eye function. ^{6 7 8 9 10}

Who Is on the Research Team?

Reza Vagefi, MD

Principal Investigator

Tufts University

Jennifer Tan, MD

Principal Investigator

Sheffield Teaching Hospital - Royal Hallamshire Hospital

Alison Rand, MD

Principal Investigator

Rand Eye Institute

Ran Ben Cnaan, MD

Principal Investigator

Sourasky Medical Center - Ichilov

David Zadok, MD

Principal Investigator

Shaarei Zedek MC

Bernard Chang, MD

Principal Investigator

Leeds Teaching Hospital - St. James University Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 22 with unilateral facial nerve palsy from conditions like Bell's palsy, Ramsay Hunt syndrome, or Lyme disease. Participants must have trouble closing one eye and be able to follow the study procedures in English, Spanish, Hebrew, or Arabic. They can't join if they have bilateral paralysis, eyelid surgery history, certain implants or allergies to BlinkER materials.

Inclusion Criteria

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

I have facial paralysis on one side due to an identified cause.

Exclusion Criteria

My eyelid closes involuntarily due to facial nerve issues.

I have paralysis on both sides of my face.

Has an implanted eyelid weight in the study eyelid

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

Screening/Baseline (Day 0)

Treatment

Participants use the BlinkER system to achieve eyelid closure

3 months

Day 1, Week 1, Week 2, Month 1, Month 2 (Remote visit), Month 3

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

What Are the Treatments Tested in This Trial?

Interventions

• BlinkER System

Trial Overview The trial is testing the BlinkER device on people with facial nerve palsy. It's a single-group study where participants use this new system designed to help them blink properly when their facial muscles can't do it alone.

How Is the Trial Designed?

Group I: BlinkER system treatment Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

Neurotrigger Ltd

Lead Sponsor

Trials

3

Recruited

110+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06542289?cond=Tick%20paralysis%20OR%20%22%22&aggFilters=status:not%20rec&viewType=Table&rank=1

Safety and Effectiveness of the BlinkER System in ... 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 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681521001492

Assessment of eye closure and blink with facial palsy A review of the literature was performed to identify the outcome measurements used to assess facial nerve function and specifically eye closure and blink. A ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12136673/

Dynamic Eyelid Reanimation in Facial Paralysis: A Systematic ... Postoperatively, 79.1% of patients felt some relief from mechanical irritation, but complete relief was obtained in only 4 patients. Complete ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06542289/safety-and-effectiveness-of-the-blinker-system-in-participants-with-facial-nerve-palsy

Safety and Effectiveness of the BlinkER System in ... A single-arm, multicenter study will be conducted to evaluate the safety and effectiveness of the Blinker system in achieving eyelid closure ...

5. advanced.onlinelibrary.wiley.com advanced.onlinelibrary.wiley.com/doi/full/10.1002/adrr.202500048

A Proof‐of‐Concept Assessment of a Novel Wearable Eyelid ... People who suffer from various forms of facial nerve palsy (FNP) regularly demonstrate a deterioration of their SB mechanism performance. Often, ...

6. ctv.veeva.com ctv.veeva.com/study/safety-and-effectiveness-of-the-blinker-system-in-participants-with-facial-nerve-palsy

Safety and Effectiveness of the BlinkER System in Participants ... A single-arm, multicenter study will be conducted to evaluate the safety and effectiveness of the Blinker system in achieving eyelid closure ...

7. clinicaltrial.be clinicaltrial.be/en/details/445287?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Safety and Effectiveness of the BlinkER System in Partici... A single-arm, multicenter study will be conducted to evaluate the safety and effectiveness of the Blinker system in achieving eyelid closure ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0010482525000721

Dynamic blinking feature extraction for automated facial ... In this study, we present an automated system for objectively extracting dynamic blink features from high-frame-rate videos to address these limitations.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11021255/

Future treatment options for facial nerve palsy: a review on ... Facial nerve palsy can cause diminished eyelid closure (lagophthalmos). This occurs due to functional deficits of the orbicularis oculi muscle, ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT06069128?cond=%22Paralysis%22&viewType=Table&rank=1

Evaluate the Usability of the Neuro-trigger Artificial Eye ... The secondary study objective is to evaluate the safety and effectiveness of the BlinkER in achieving eyelid closure during the study visits with facial nerve ...