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

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: Terminated
• Conditions: Blepharoptosis; Lagophthalmos
• Intervention / Treatment: Device: Neuromuscular electrical stimulation; Device: Sham neuromuscular electrical stimulation

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Marginal reflex distance-1 (MRD-1)	Measure of eyelid function for participants with CN III or CN VII palsy	Within 1 week of last treatment session.
Palpebral fissure height	Measure of eyelid function for participants with CN III or CN VII palsy	Within 1 week of last treatment session.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
World Health Organization Quality of Life - BREF (WHOQOL-BREF)	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	Measure of eyelid function in participants with CN III or CN VII palsy	Within 1 week of last treatment session.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance visual acuity	Measure of overall eye health and function	Within 1 week of last treatment session.
Distance alternate cover test.	Measure of overall eye health and function	Within 1 week of last treatment.
Pupil test	Measure of overall eye health and function	Within 1 week of last treatment session.
Oculomotor exam	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).	Measure of ophthalmic involvement in facial function in participants with CN VII palsy	Within 1 week of last treatment session.

Collaborators and Investigators

• Sponsor: Brooks Rehabilitation
• Investigators: Principal Investigator: Kenneth Ngo, MD, Brooks Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2017
• Primary Completion (Actual): October 16, 2019
• Study Completion (Actual): October 16, 2019

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: August 1, 2017
• First Posted (Actual): August 4, 2017

Study Record Updates

• Last Update Posted (Estimate): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: NMES
• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharoptosis
• Other Study ID 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