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Procedure

BlinkER Device for Facial Nerve Palsy (Paralysis Trial)

N/A

Waitlist Available

Led By Reza Vagefi, MD

Research Sponsored by Neurotrigger Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unilateral facial palsy due to Bell's palsy, Ramsay Hunt syndrome, malignant or benign tumor resection, Lyme disease, cerebrovascular accident (hemorrhagic or ischemic), or trauma

22 years of age or older

Must not have

Synkinesis resulting in eyelid closure

Bilateral facial paralysis (e.g., Parkinson's Disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the Blinker system in people with facial nerve paralysis to see if it is safe and effective.

Who is the study for?

This trial is for adults over 22 with unilateral facial nerve palsy from conditions like Bell's palsy, Ramsay Hunt syndrome, or Lyme disease. Participants must have trouble closing one eye and be able to follow the study procedures in English, Spanish, Hebrew, or Arabic. They can't join if they have bilateral paralysis, eyelid surgery history, certain implants or allergies to BlinkER materials.

What is being tested?

The trial is testing the BlinkER device on people with facial nerve palsy. It's a single-group study where participants use this new system designed to help them blink properly when their facial muscles can't do it alone.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include skin irritation from the device materials (polyethylene tape or hydrogel), discomfort during use of the device and any unforeseen reactions related to electronic stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have facial paralysis on one side due to an identified cause.

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I am 22 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My eyelid closes involuntarily due to facial nerve issues.

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I have paralysis on both sides of my face.

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I have had surgery or treatment to help close my eyelids.

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I do not have severe diabetes, heart disease, neurological issues, immune deficiencies, or active cancer.

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I do not have severe eye or surrounding skin infections.

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I have been diagnosed with or suspected to have epilepsy.

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I have cancerous lesions where electrodes will be placed.

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I have eye issues that make it hard to see my pupil.

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I have facial nerve issues or a specific eye condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The percent of participants who achieve eyelid closure graded by independent, masked graders at a reading center.

Secondary study objectives

Percent of participants who achieve eyelid closure in the study eye at 1 month.

Percent of participants who achieve eyelid closure in the study eye at 3 months.

safety outcome is the rate of adverse events through 3 months.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: BlinkER system treatmentExperimental Treatment1 Intervention

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.

0 / 11Eligibility criteria met