NMES to Improve Eyelid Functions in Cranial Nerve (CN) III and VII Palsy (EyeStim)
Primary Purpose
Blepharoptosis, Lagophthalmos
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuromuscular electrical stimulation
Sham neuromuscular electrical stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Blepharoptosis focused on measuring NMES
Eligibility Criteria
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.
Sites / Locations
- Brooks Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
EyeStim Group
Control Group
Arm Description
Receive an active NMES treatment to the targeted muscles controlling eyelid function.
Undergo all the same procedures as the EyeStim group except receive a sham NMES treatment.
Outcomes
Primary Outcome Measures
Marginal reflex distance-1 (MRD-1)
Measure of eyelid function for participants with CN III or CN VII palsy
Palpebral fissure height
Measure of eyelid function for participants with CN III or CN VII palsy
Secondary Outcome Measures
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Measure of Quality of Life for participants with CN III or CN VII palsy
Upper eyelid crease distance
Measure of eyelid function in participants with CN III or CN VII palsy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03239418
Brief Title
NMES to Improve Eyelid Functions in Cranial Nerve (CN) III and VII Palsy
Acronym
EyeStim
Official Title
A Novel Treatment Using Neuromuscular Electrical Stimulation to Improve Eyelid Function in Patients With CN III and CN VII Palsy.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment
Study Start Date
January 6, 2017 (Actual)
Primary Completion Date
October 16, 2019 (Actual)
Study Completion Date
October 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brooks Rehabilitation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharoptosis, Lagophthalmos
Keywords
NMES
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Active treatment vs. Sham control
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EyeStim Group
Arm Type
Experimental
Arm Description
Receive an active NMES treatment to the targeted muscles controlling eyelid function.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Undergo all the same procedures as the EyeStim group except receive a sham NMES treatment.
Intervention Type
Device
Intervention Name(s)
Neuromuscular electrical stimulation
Intervention Description
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
Intervention Name(s)
Sham neuromuscular electrical stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Marginal reflex distance-1 (MRD-1)
Description
Measure of eyelid function for participants with CN III or CN VII palsy
Time Frame
Within 1 week of last treatment session.
Title
Palpebral fissure height
Description
Measure of eyelid function for participants with CN III or CN VII palsy
Time Frame
Within 1 week of last treatment session.
Secondary Outcome Measure Information:
Title
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Description
Measure of Quality of Life for participants with CN III or CN VII palsy
Time Frame
Within 1 week of last treatment session.
Title
Upper eyelid crease distance
Description
Measure of eyelid function in participants with CN III or CN VII palsy
Time Frame
Within 1 week of last treatment session.
Other Pre-specified Outcome Measures:
Title
Distance visual acuity
Description
Measure of overall eye health and function
Time Frame
Within 1 week of last treatment session.
Title
Distance alternate cover test.
Description
Measure of overall eye health and function
Time Frame
Within 1 week of last treatment.
Title
Pupil test
Description
Measure of overall eye health and function
Time Frame
Within 1 week of last treatment session.
Title
Oculomotor exam
Description
Measure of overall eye health and function in participants with CN III palsy
Time Frame
Within 1 week of last treatment session.
Title
Cornea, Static Asymmetry, Dynamic Function, Synkinesis Classification Scale (CADS).
Description
Measure of ophthalmic involvement in facial function in participants with CN VII palsy
Time Frame
Within 1 week of last treatment session.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Ngo, MD
Organizational Affiliation
Brooks Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooks Rehabilitation
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
NMES to Improve Eyelid Functions in Cranial Nerve (CN) III and VII Palsy
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