Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
Key facts
- Where
- Deerfield Beach, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 22 and 120 years old?
Source: NCT06542289, who can take part
Where in United States
- Rand Eye InstituteDeerfield Beach, United StatesContact: Alison Rand, MDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Neurotrigger Ltd
- Trial code
- NCT06542289
- Record updated
- 10 June 2025
- Original description
Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.Read full original descriptionShow less
Single-Arm, Multicenter Study to Evaluate the Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.
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: History of prior intervention that is providing closure of the eyelids (e.g., facial reanimation, complete tarsorrhaphy surgery, etc.); 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; Bilateral facial paralysis (for example Parkinson's Disease); 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; Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device; Known allergy to any of the patient-contacting materials of the BlinkeER electrode (i.e. polyethylene (PET) film tape or hydrogel); 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; Has an implanted eyelid weight in the study eyelid; Cancerous lesions in the area where the BlinkER system electrodes will be applied; Cornea or iris abnormalities that preclude visualization of the pupil; Cranial nerve V palsy or neurotrophic keratitis; Synkinesis that results in eyelid closure; Participants who are pregnant or nursing.