Back to search results

BlinkER System for Facial Nerve Palsy

This study is testing the BlinkER System, a device designed to help people with facial nerve palsy (weakness or paralysis of facial muscles) close their eyelids. You might be able to join if you are 22 years or older and have one-sided facial palsy from conditions like Bell's palsy, Ramsay Hunt syndrome, Lyme disease, or stroke, and have trouble closing your eye when blinking. The main goal is to see how many participants can achieve eyelid closure after using the BlinkER System for two weeks. The current status of this study is unclear, and it plans to enroll about 80 participants.

Study design
This is a single-arm study, meaning all participants will receive the BlinkER device. It aims to enroll at least 80 participants.
What's involved
You would use the BlinkER System for 8-16 hours daily for three months, attending several in-person and one remote visit during this time.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome for eyelid closure is measured at 2 weeks, and the total study duration is 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06542289

Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy

Not Yet Recruiting
NAAges 22+InterventionalTreatment
Neurotrigger Ltd
~80 participants
Updated 2025-06-10 on ClinicalTrials.gov
What's tested:BlinkER device.

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The percent of participants who achieve eyelid closure graded by independent, masked graders at a reading center.
Measured over 2 weeks

Conditions

Bell's Palsy
Ramsay Hunt Syndrome
Lyme Disease
Facial Palsy

Explore related trials

Borrelia Burgdorferi InfectionFacial Nerve ParalysisHerpes Zoster Oticus

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Ran Ben Cnaan, MD · PRINCIPAL_INVESTIGATOR · Sourasky Medical Center - Ichilov
  • Alison Rand, MD · PRINCIPAL_INVESTIGATOR · Rand Eye Institute
  • Jennifer Tan, MD · PRINCIPAL_INVESTIGATOR · Sheffield Teaching Hospital - Royal Hallamshire Hospital
  • David Zadok, MD · PRINCIPAL_INVESTIGATOR · Shaarei Zedek MC
  • Bernard Chang, MD · PRINCIPAL_INVESTIGATOR · Leeds Teaching Hospital - St. James University Hospital
  • Reza Vagefi, MD · PRINCIPAL_INVESTIGATOR · Tufts University

Who to contact

Hila Kfir
[email protected]
+972-523313350
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.

What this trial measures

  • The percent of participants who achieve eyelid closure graded by independent, masked graders at a reading center.2 weeks

    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