Recruiting soon

ParalysisBlinkER System for Facial Nerve Palsy Eyelid Closure

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What is being tested

BlinkER device.

Device
Who is being recruted

Varicella Zoster Virus Infection+25

+ Vector Borne Diseases

+ Bacterial Infections and Mycoses

From 22 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorNeurotrigger Ltd
Study ContactHila KfirMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2025

Actual date on which the first participant was enrolled.

This study is focused on testing a device called the BlinkER system to see if it is safe and works well for people with facial nerve palsy, a condition that affects the muscles in the face and makes it hard to close the eyelids. The study is important because it seeks to help people who have trouble blinking or closing their eyes due to issues like Bell's palsy, Lyme disease, or after a stroke or injury. By finding an effective solution, the study could improve the quality of life for these individuals by addressing challenges they face daily. Participants in this study will use the BlinkER system for three months. The device aims to help close the eyelid, and its effectiveness will be checked at various points over the study period, starting with an initial screening and then follow-up visits at Day 1, Week 1, Week 2, and the end of each month. Some visits will be done remotely. The study will monitor how well the eyelid closure works and if there are any side effects, ensuring participants' safety throughout the process. The entire study is expected to take about a year to complete.

Official TitleSingle-Arm, Multicenter Study to Evaluate the Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
NCT06542289
Principal SponsorNeurotrigger Ltd
Study ContactHila KfirMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 22 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Varicella Zoster Virus InfectionVector Borne DiseasesBacterial Infections and MycosesBacterial InfectionsBorrelia InfectionsCranial Nerve DiseasesDNA Virus InfectionsEar DiseasesFacial Nerve DiseasesFacial ParalysisHerpes ZosterHerpesviridae InfectionsInfectionsLyme DiseaseStomatognathic DiseasesMouth DiseasesNervous System DiseasesNeurologic ManifestationsOtorhinolaryngologic DiseasesParalysisSigns and SymptomsSpirochaetales InfectionsPathological Conditions, Signs and SymptomsVirus DiseasesHerpes Zoster OticusGram-Negative Bacterial InfectionsTick-Borne DiseasesBell Palsy

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Rand Eye Institute

Deerfield Beach, United StatesOpen Rand Eye Institute in Google Maps
Recruiting soonOne Study Center