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

NCT ID: NCT03239418

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-06

Study Completion Date

2019-10-16

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.

Detailed Description

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Conditions

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Blepharoptosis Lagophthalmos

Keywords

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NMES

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Active treatment vs. Sham control
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Participants in treatment and sham group undergo all of the same procedures except a sham NMES treatment is provided to the control group. Only the treating clinician is aware of group allocation. The investigator and outcomes assessor are unaware of group allocation.

Study Groups

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EyeStim Group

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

Group Type EXPERIMENTAL

Neuromuscular electrical stimulation

Intervention Type DEVICE

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.

Control Group

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

Group Type SHAM_COMPARATOR

Sham neuromuscular electrical stimulation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brooks Rehabilitation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenneth Ngo, MD

Role: PRINCIPAL_INVESTIGATOR

Brooks Rehabilitation

Locations

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Brooks Rehabilitation

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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BRCRC2016_001

Identifier Type: -

Identifier Source: org_study_id