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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.

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 data supports the effectiveness of the BlinkER System treatment for facial nerve palsy?

Research on similar treatments, like functional electrical stimulation and implantable devices, shows they can help restore blinking in cases of facial nerve paralysis. These treatments work by using electrical signals to stimulate the muscles needed for blinking, which can protect the eye and improve appearance. ^{1 2 3 4 5}

Is the BlinkER Device safe for use in humans?

The BlinkER Device, tested under various names, has been used in studies with rabbits and a small group of human participants with facial nerve palsy. In these studies, the device was able to safely induce blinking without significant adverse effects, suggesting it is generally safe for human use. ^{2 3 4 6 7}

How does the BlinkER System treatment for facial nerve palsy differ from other treatments?

The BlinkER System is unique because it uses a functional electrical stimulation (FES) approach to restore synchronized blinking by detecting signals from the healthy side of the face to trigger the paralyzed side, providing a more natural and synchronized blink compared to other methods. ^{2 3 4 7 8}

Research Team

Jennifer Tan, MD

Principal Investigator

Sheffield Teaching Hospital - Royal Hallamshire Hospital

Bernard Chang, MD

Principal Investigator

Leeds Teaching Hospital - St. James University Hospital

Reza Vagefi, MD

Principal Investigator

Tufts University

Ran Ben Cnaan, MD

Principal Investigator

Sourasky Medical Center - Ichilov

Alison Rand, MD

Principal Investigator

Rand Eye Institute

David Zadok, MD

Principal Investigator

Shaarei Zedek MC

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Blink recovery in patients with Bell's palsy: a neurophysiological and behavioral longitudinal study. [2013]

2. China pubmed.ncbi.nlm.nih.gov

[Blink restoration by the functional electrical stimulation in unilateral facial nerve palsy rabbits]. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Overcoming Facial Paralysis with an Implantable Actuator for Restoration of Blink. [2022]

4. Turkey pubmed.ncbi.nlm.nih.gov

Implantable Closed-Loop System for Restoration of Blinking in Case of Unilateral Facial Nerve Paralysis. [2022]

5. Croatia pubmed.ncbi.nlm.nih.gov

Blink reflex in the prediction of outcome of idiopathic peripheral partial facioparesis: follow-up study. [2004]

6. United States pubmed.ncbi.nlm.nih.gov

Electrically Induced Blink for the Prevention of Ocular Symptoms and Blurred Vision in Patients With Acute Facial Nerve Palsy. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

A blink restoration system with contralateral EMG triggered stimulation and real-time artifact blanking. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A spectacle device to treat facial nerve paralysis. [2016]