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

Part of paid clinical trials in Deerfield Beach, Florida.

Sponsor
Neurotrigger Ltd
Study ID
NCT06542289
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • BlinkER device. — 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.

Study Details

Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.

Key Dates

Start date
Oct 1, 2025
Status verified
Nov 2024
Primary completion
Oct 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BlinkER system treatment
    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.

Primary Outcome Measure

The percent of participants who achieve eyelid closure graded by independent, masked graders at a reading center. [ Time Frame: 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rand Eye InstituteDeerfield BeachFlorida33064
Alison Rand, MD
[email protected]
954-782-1700

Find similar trials in Deerfield Beach, FL

By research site
Rand Eye Institute· Deerfield Beach, FL

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