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

Launched by NEUROTRIGGER LTD · Aug 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a device called the BlinkER System for people with facial nerve palsy, which can happen due to conditions like Bell's palsy, Ramsay Hunt syndrome, Lyme disease, or after surgeries. The trial is designed for adults aged 22 and older who have difficulty closing one eye properly, which is measured by a specific scoring system. To participate, individuals must be able to provide informed consent and speak English, Spanish, Hebrew, or Arabic.

Participants in the trial will receive training on how to use the BlinkER System, which aims to help them blink more effectively and protect their eyes. The study is not yet recruiting participants, and those who join will be closely monitored to see how well the device works and if it is safe to use. It's important to note that certain health conditions and past treatments may make someone ineligible to participate, so interested individuals should discuss their specific situation with their healthcare provider.

Gender

ALL

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.