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NOT YET RECRUITING
NCT06542289
NA

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

Sponsor: Neurotrigger Ltd

View on ClinicalTrials.gov

Summary

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

Official title: Single-Arm, Multicenter Study to Evaluate the Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy

Key Details

Gender

All

Age Range

22 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-10-01

Completion Date

2026-11-30

Last Updated

2025-06-10

Healthy Volunteers

No

Interventions

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.

Locations (1)

Rand Eye Institute

Deerfield Beach, Florida, United States