Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy (Paralysis)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lyme Disease; Facial Palsy; Bell's Palsy; Ramsay Hunt Syndrome
• Intervention / Treatment: Device: BlinkER device.

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hila Kfir; Phone Number: +972-523313350; Email: hila@nt-med.com
• Study Contact Backup: Name: Nikolai Kunicher; Phone Number: +972- 522963130; Email: nikolai@nt-med.com

Study Locations

• United States
  • Florida
    • Deerfield Beach, Florida, United States, 33064
      • Rand Eye Institute
      • Contact: Alison Rand, MD; Phone Number: 954-782-1700; Email: allisonrandmd@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BlinkER system treatment; 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	3 months

Collaborators and Investigators

• Sponsor: Neurotrigger Ltd
• Investigators: Principal Investigator: Ran Ben Cnaan, MD, Sourasky Medical Center - Ichilov; Principal Investigator: Alison Rand, MD, Rand Eye Institute; Principal Investigator: Jennifer Tan, MD, Sheffield Teaching Hospital - Royal Hallamshire Hospital; Principal Investigator: David Zadok, MD, Shaarei Zedek MC; Principal Investigator: Bernard Chang, MD, Leeds Teaching Hospital - St. James University Hospital; Principal Investigator: Reza Vagefi, MD, Tufts University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: August 4, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 8, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: BlinkER System; BlinkER
• Additional Relevant MeSH Terms: Vector Borne Diseases; Varicella Zoster Virus Infection; Neurologic Manifestations; Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Pathologic Processes; Disease Attributes; Infections; Virus Diseases; DNA Virus Infections; Otorhinolaryngologic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Ear Diseases; Herpesviridae Infections; Cranial Nerve Diseases; Herpes Zoster; Lyme Disease; Paralysis; Facies; Bell Palsy; Facial Paralysis; Herpes Zoster Oticus; Facial Nerve Diseases
• Other Study ID Numbers: NT-CLN-00200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No