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Starting soon Not applicable

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

NCT06542289 · tracked via the Priya Life Science USA tracker
Sponsor
Neurotrigger Ltd
Phase
Not applicable
Started
2025-10-01
Last updated
2025-06-10

Condition(s) studied

Bell's PalsyRamsay Hunt SyndromeLyme DiseaseFacial Palsy

Investigational drug(s) / intervention(s)

BlinkER 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.

Study 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.

Eligibility

Sex
ALL
Min age
22 Years
Max age
120 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • The percent of participants who achieve eyelid closure graded by independent, masked graders at a reading center. — 2 weeks
    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

Trial sites (1)

FacilityCityRegionStatus
Rand Eye Institute Deerfield Beach Florida
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06542289 on ClinicalTrials.gov ↗ ← All trials in the USA