Clinical trial NCT06542289: Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
Official title: Single-Arm, Multicenter Study to Evaluate the Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bell's Palsy
Ramsay Hunt Syndrome
Lyme Disease
Facial Palsy
Keywords: BlinkER System
BlinkER
Lead sponsor: Neurotrigger Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-07
Enrollment: 80
Sex: ALL
Minimum age (years): 22
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-arm study for subjects diagnosed with facial nerve palsy.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The percent of participants who achieve eyelid closure graded by independent, masked graders at a reading center.
timeFrame: 2 weeks
Secondary outcomes:
measure: Percent of participants who achieve eyelid closure in the study eye at 1 month.
timeFrame: up to 1 month
measure: Percent of participants who achieve eyelid closure in the study eye at 3 months.
timeFrame: up to 3 months
measure: safety outcome is the rate of adverse events through 3 months.
timeFrame: 3 months
Other outcomes:
Locations:
city: Deerfield Beach
country: United States
facility: Rand Eye Institute
state: Florida
Study officials:
affiliation: Sourasky Medical Center - Ichilov
name: Ran Ben Cnaan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rand Eye Institute
name: Alison Rand, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheffield Teaching Hospital - Royal Hallamshire Hospital
name: Jennifer Tan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaarei Zedek MC
name: David Zadok, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Leeds Teaching Hospital - St. James University Hospital
name: Bernard Chang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tufts University
name: Reza Vagefi, MD
role: PRINCIPAL_INVESTIGATOR
References: