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

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

Conditions
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Blepharoptosis, Lagophthalmos

Intervention / Treatment
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* Device: Neuromuscular electrical stimulation
* Device: Sham neuromuscular electrical stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Active treatment vs. Sham control
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EyeStim Group<br>Receive an active NMES treatment to the targeted muscles controlling eyelid function. | Device: Neuromuscular electrical stimulation<br>* 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.<br>|
| Sham Comparator: Control Group<br>Undergo all the same procedures as the EyeStim group except receive a sham NMES treatment. | Device: Sham neuromuscular electrical stimulation<br>* 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.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NMES