NCT06542289

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Neurotrigger Ltd · Industry
• Sex: All
• Age: 22 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Bell's Palsy
• Ramsay Hunt Syndrome
• Lyme Disease
• Facial Palsy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-10-31
• Completion: 2026-11-30
• First posted: 2024-08-07
• Last updated: 2025-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study