An interventional study of BlinkER device. in Bell's Palsy, Ramsay Hunt Syndrome and Lyme Disease, sponsored by Neurotrigger Ltd. Not yet recruiting at 1 site in United States. Open to participants aged 22 Years to 120 Years. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by Neurotrigger Ltd · Not applicable, Interventional, and Treatment
Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.
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.
85 studies on the registry are indexed under Bell Palsy; 30 are open to participants now.
This study's planned enrollment of 80 is above the median of 42 across 70 interventional studies indexed under Bell Palsy.
Browse Bell Palsy studies →Neurotrigger Ltd is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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22 years of age or older
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: BlinkER 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.
The percent of participants who achieve eyelid closure graded by independent, masked graders at a reading center.
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
Time frame: 2 weeks
Percent of participants who achieve eyelid closure in the study eye at 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
Time frame: up to 1 month
Percent of participants who achieve eyelid closure in the study eye at 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
Time frame: up to 3 months
safety outcome is the rate of adverse events through 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.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2025; primary completion for Oct 2026, 12 months later.
Of 40 interventional studies with no phase under Bell Palsy, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's planned 12 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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