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

Starting soon · Not applicable

Conditions studied: Bell's Palsy, Ramsay Hunt Syndrome, Lyme Disease, Facial Palsy

In brief

Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.

Key facts

Study ID

NCT06542289

Run by

Neurotrigger Ltd

People needed

80

Starts

2025-10-01

Expected to finish

2026-11-30

Last updated by the study team

2025-06-10

Who can join

Age: 22 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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.

Where it is running

• Rand Eye Institute — Deerfield Beach, Florida, United States

Full record on ClinicalTrials.gov

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