[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557759":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":41,"locations":51,"responsibleParty":68,"collaborators":20,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":20,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":96,"whyStopped":20,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Neurotrigger Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BlinkER system treatment","EXPERIMENTAL","A prospective single-arm multicenter pivotal study designed to evaluate the safety and effectiveness of the BlinkER System in achieving eyelid closure in participants with facial nerve palsy. Participants will receive the NeuroTrigger Basic System and use it for up to 3 months.",[13],"Device: BlinkER device.",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","BlinkER device.","Participants will use the BlinkER System for 8-16 hours daily (removed during sleep) at approximately 10 blinks\u002Fminute. 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.",[9],null,[22,26,29,32,35,38],{"name":23,"affiliation":24,"role":25},"Ran Ben Cnaan, MD","Sourasky Medical Center - Ichilov","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":28,"role":25},"Alison Rand, MD","Rand Eye Institute",{"name":30,"affiliation":31,"role":25},"Jennifer Tan, MD","Sheffield Teaching Hospital - Royal Hallamshire Hospital",{"name":33,"affiliation":34,"role":25},"David Zadok, MD","Shaarei Zedek MC",{"name":36,"affiliation":37,"role":25},"Bernard Chang, MD","Leeds Teaching Hospital - St. James University Hospital",{"name":39,"affiliation":40,"role":25},"Reza Vagefi, MD","Tufts University",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":20,"email":46},"Hila Kfir","CONTACT","+972-523313350","hila@nt-med.com",{"name":48,"role":44,"phone":49,"phoneExt":20,"email":50},"Nikolai Kunicher","+972- 522963130","nikolai@nt-med.com",[52],{"facility":28,"status":20,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Deerfield Beach","Florida","33064","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-80.09977,26.31841,{"lat":62,"lon":61},[65],{"name":27,"role":44,"phone":66,"phoneExt":20,"email":67},"954-782-1700","allisonrandmd@gmail.com",{"type":69,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","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":82,"type":83},80,"ESTIMATED","INTERVENTIONAL",[86],"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.",[89,90,91,92],"Bell's Palsy","Ramsay Hunt Syndrome","Lyme Disease","Facial Palsy",[94,95],"BlinkER System","BlinkER","NOT_YET_RECRUITING","2025-06-08",{"date":99,"type":100},"2025-06-10","ACTUAL",{"date":102,"type":83},"2025-10-01",{"date":104,"type":83},"2026-11-30",{"name":5,"class":6},1]