Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-120
SponsorNeurotrigger Ltd
About this trial
Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
BlinkER device.
DeviceParticipants 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: BlinkER system treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
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 month2
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 months3
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: