Bell's Palsy, Facial Palsy, Lyme Disease, Ramsay Hunt Syndrome
Conditions
Keywords
BlinkER System, BlinkER
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.
Interventions
DEVICEBlinkER 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.
Sponsors
Neurotrigger Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label study
Intervention model description
A single-arm study for subjects diagnosed with facial nerve palsy.
Eligibility
Sex/Gender
ALL
Age
22 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
Countries
United States
Contacts
Primary ContactHila Kfir
Backup ContactNikolai Kunicher
Outcome results
None listed