Suspended

EyeStimA Novel Treatment Using Neuromuscular Electrical Stimulation to Improve Eyelid Function in Patients With CN III and CN VII Palsy.

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What is being tested

Neuromuscular electrical stimulation

+ Sham neuromuscular electrical stimulation

Device
Who is being recruted

Lagophthalmos+2

+ Blepharoptosis

+ Eye Diseases

Over 19 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: January 2017
See protocol details

Summary

Principal SponsorBrooks Rehabilitation
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 6, 2017

Actual date on which the first participant was enrolled.

Traumatic brain injury, stroke and other neurological conditions may result in weakness of the muscles that either open or close the eye. This is generally a result of impaired functioning of the oculomotor or facial cranial nerves. Current treatments to improve eye opening or closing are either invasive or largely ineffective. This study tests a noninvasive means of improving eyelid opening and closing by applying a previously demonstrated safe and effective neuromuscular electrical stimulation (NMES) intervention to the muscles controlling eyelid movement. Participants in this study will either receive the investigational NMES protocol 30 min per day for five days or a sham NMES for the same period. The primary outcome for this study is the participants' ability to open or close their affected eye. Secondary outcomes include additional measures of eye and corneal health.

Official TitleA Novel Treatment Using Neuromuscular Electrical Stimulation to Improve Eyelid Function in Patients With CN III and CN VII Palsy.
NCT03239418
Principal SponsorBrooks Rehabilitation
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

26 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

LagophthalmosBlepharoptosisEye DiseasesEye ManifestationsEyelid Diseases

Criteria

2 inclusion criteria required to participate
Cranial nerve III (oculomotor nerve) and/or cranial nerve IV (facial nerve) palsy.
Able to read and communicate in English.
5 exclusion criteria prevent from participating
Idiopathic onset of CN III and/or CN IV palsy.
Traumatic injury to the eye or eyelid.
Active wounds in the treatment area.
Presence of swelling or infection in or surrounding the affected eye.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Receive an active NMES treatment to the targeted muscles controlling eyelid function.

Group II

Sham
Undergo all the same procedures as the EyeStim group except receive a sham NMES treatment.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Brooks Rehabilitation

Jacksonville, United StatesOpen Brooks Rehabilitation in Google Maps
SuspendedOne Study Center