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

Not Applicable

Not yet recruiting

• Conditions: Lyme Disease; Facial Palsy; Bell's Palsy; Ramsay Hunt Syndrome
• Interventions: Device: BlinkER device.

• Registration Number: NCT06542289
• Lead Sponsor: Neurotrigger Ltd

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.

Study Timeline

• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-08-04
• Study First Posted: 2024-08-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-17
• Last Update Posted: 2024-11-19
• Study Start: 2025-02-01
• Primary Completion: 2025-08-31
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BlinkER system treatment	BlinkER device.	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.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Percent of participants who achieve eyelid closure in the study eye at 3 months.	up to 3 months	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
Percent of participants who achieve eyelid closure in the study eye at 1 month.	up to 1 month	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
safety outcome is the rate of adverse events through 3 months.	3 months	safety measures include IOP, BCVA, slit lamp biomicroscopy and non-mydriatic fundus findings, and VAS pain and discomfort questionnaire evaluated at the follow-up visits.

Trial Locations

Locations (1)

Rand Eye Institute; 🇺🇸 Deerfield Beach, Florida, United States