[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ramsay-hunt-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ramsay-hunt-syndrome":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100557759","safety-and-effectiveness-of-the-blinker-system-in-participants-with-facial-nerve-palsy-100557759",false,"NCT06542289","Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy","Single-Arm, Multicenter Study to Evaluate the Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy","Paralysis","Inclusion Criteria:\n\n22 years of age or older\n\n* 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\n* 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.\n* Willing and able to comply with the study procedures and follow-up\n* Willing and able to provide informed consent\n* English, Spanish, or Hebrew, Arabic -speaking\n* 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.\n* Participant successfully completes BlinkER System training and certification\n\nExclusion Criteria:\n\n* Bilateral facial paralysis (for example Parkinson's Disease)\n* History of prior intervention that is providing closure of the eyelids (e.g., facial reanimation, complete tarsorrhaphy surgery, etc.)\n* Has an implanted eyelid weight in the study eyelid.\n* 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\n* Signs of corneal infection, severe ocular surface inflammation, or significant periorbital skin inflammation\u002Finfection\n* Suspected or diagnosed epilepsy.\n* Cancerous lesions in the area where the BlinkER system electrodes will be applied.\n* Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device\n* Cornea or iris abnormalities that preclude visualization of the pupil\n* Cranial nerve V palsy or neurotrophic keratitis\n* Synkinesis that results in eyelid closure\n* Known allergy to any of the patient-contacting materials of the BlinkeER electrode (i.e. polyethylene (PET) film tape or hydrogel)\n* Participants who are pregnant or nursing.\n* 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.\n* 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.","ALL","22 Years","120 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"NA","Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.",[28,29,30,31],"Bell's Palsy","Ramsay Hunt Syndrome","Lyme Disease","Facial Palsy",[33,34],"BlinkER System","BlinkER","NOT_YET_RECRUITING","2025-06-08",{"date":38,"type":39},"2025-06-10","ACTUAL",{"date":41,"type":22},"2025-10-01",{"date":43,"type":22},"2026-11-30",{"name":45,"class":46},"Neurotrigger Ltd","INDUSTRY"]