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

NCT06542289 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-06-10

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • Neurotrigger Ltd

    lead INDUSTRY

Principal Investigators

  • Ran Ben Cnaan, MD · Sourasky Medical Center - Ichilov

  • Alison Rand, MD · Rand Eye Institute

  • Jennifer Tan, MD · Sheffield Teaching Hospital - Royal Hallamshire Hospital

  • David Zadok, MD · Shaarei Zedek MC

  • Bernard Chang, MD · Leeds Teaching Hospital - St. James University Hospital

  • Reza Vagefi, MD · Tufts University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-10-31
Completion
2026-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06542289 on ClinicalTrials.gov