NMES to Improve Eyelid Functions in Cranial Nerve (CN) III and VII Palsy (EyeStim)

December 19, 2022 updated by: Brooks Rehabilitation

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Brooks Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cranial nerve III (oculomotor nerve) and/or cranial nerve IV (facial nerve) palsy.
  • Able to read and communicate in English.

Exclusion Criteria:

  • 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.
  • Diminished sensation in the area to be treated.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EyeStim Group
Receive an active NMES treatment to the targeted muscles controlling eyelid function.
Device: Neuromuscular electrical stimulation
A low level electrical current is applied to the muscle that control eyelid function through small electrodes applied to the skin over the target muscles. Treatment is applied daily for 5 consecutive days and exercises for eyelid function are performed in conjunction with the stimulation.
Sham Comparator: Control Group
Undergo all the same procedures as the EyeStim group except receive a sham NMES treatment.
Device: Sham neuromuscular electrical stimulation
Electrodes are applied to the skin over the target muscles and patient perform the exercises for eyelid function for 5 consecutive days just as in the experimental group, However participants do not receive the electrical stimulation. Due to the low intensity of the stimulation all participants regardless of group allocation are told they may or may not feel the electrical stimulation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Marginal reflex distance-1 (MRD-1)
Time Frame: Within 1 week of last treatment session.
Measure of eyelid function for participants with CN III or CN VII palsy
Within 1 week of last treatment session.
Palpebral fissure height
Time Frame: Within 1 week of last treatment session.
Measure of eyelid function for participants with CN III or CN VII palsy
Within 1 week of last treatment session.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Time Frame: Within 1 week of last treatment session.
Measure of Quality of Life for participants with CN III or CN VII palsy
Within 1 week of last treatment session.
Upper eyelid crease distance
Time Frame: Within 1 week of last treatment session.
Measure of eyelid function in participants with CN III or CN VII palsy
Within 1 week of last treatment session.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Distance visual acuity
Time Frame: Within 1 week of last treatment session.
Measure of overall eye health and function
Within 1 week of last treatment session.
Distance alternate cover test.
Time Frame: Within 1 week of last treatment.
Measure of overall eye health and function
Within 1 week of last treatment.
Pupil test
Time Frame: Within 1 week of last treatment session.
Measure of overall eye health and function
Within 1 week of last treatment session.
Oculomotor exam
Time Frame: Within 1 week of last treatment session.
Measure of overall eye health and function in participants with CN III palsy
Within 1 week of last treatment session.
Cornea, Static Asymmetry, Dynamic Function, Synkinesis Classification Scale (CADS).
Time Frame: Within 1 week of last treatment session.
Measure of ophthalmic involvement in facial function in participants with CN VII palsy
Within 1 week of last treatment session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brooks Rehabilitation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kenneth Ngo, MD, Brooks Rehabilitation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 16, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 16, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BRCRC2016_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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