Status:
NOT_YET_RECRUITING
Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
Lead Sponsor:
Neurotrigger Ltd
Conditions:
Bell's Palsy
Ramsay Hunt Syndrome
Eligibility:
All Genders
22-120 years
Phase:
NA
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 pals...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06542289
Start Date
October 1 2025
End Date
November 30 2026
Last Update
June 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rand Eye Institute
Deerfield Beach, Florida, United States, 33064