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

NCT06542289 | Not Yet Recruiting FDA Device

• 1 other identifier: NT-CLN-00200
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bell's Palsy; Ramsay Hunt Syndrome; Lyme Disease; Facial Palsy

Keywords

BlinkER System; BlinkER

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percent of participants who achieve eyelid closure in the study eye at 1 month.

  up to 1 month

• Percent of participants who achieve eyelid closure in the study eye at 3 months.

  up to 3 months

• safety outcome is the rate of adverse events through 3 months.

  3 months

Study Arms (1)

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.

Device: BlinkER device.

Interventions

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.

BlinkER system treatment

Eligibility Criteria

• Age: 22 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurotrigger Ltd: lead

Study Sites (1)

Rand Eye Institute

Deerfield Beach, Florida, 33064, United States

Location

MeSH Terms

Conditions

Bell Palsy; Herpes Zoster Oticus; Lyme Disease; Facial Paralysis

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Herpes Zoster; Varicella Zoster Virus Infection; Ear Diseases; Otorhinolaryngologic Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hila Kfir

CONTACT

+972-523313350; hila@nt-med.com

Nikolai Kunicher

CONTACT

+972- 522963130; nikolai@nt-med.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single-arm study for subjects diagnosed with facial nerve palsy.

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: August 7, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 10, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)