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

NCT ID: NCT06542289

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-11-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BlinkER device.

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neurotrigger Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ran Ben Cnaan, MD

Role: PRINCIPAL_INVESTIGATOR

Sourasky Medical Center - Ichilov

Alison Rand, MD

Role: PRINCIPAL_INVESTIGATOR

Rand Eye Institute

Jennifer Tan, MD

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospital - Royal Hallamshire Hospital

David Zadok, MD

Role: PRINCIPAL_INVESTIGATOR

Shaarei Zedek MC

Bernard Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Leeds Teaching Hospital - St. James University Hospital

Reza Vagefi, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts University

Locations

Rand Eye Institute

Deerfield Beach, Florida, United States

Countries

United States

Central Contacts

Hila Kfir

Role: CONTACT

hila@nt-med.com

+972-523313350

Nikolai Kunicher

Role: CONTACT

nikolai@nt-med.com

+972- 522963130

Facility Contacts

Alison Rand, MD

Role: primary

allisonrandmd@gmail.com

954-782-1700

Other Identifiers

NT-CLN-00200

Identifier Type: -

Identifier Source: org_study_id