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Lack of recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EyeStim Group | Experimental | Receive an active NMES treatment to the targeted muscles controlling eyelid function. |
|
| Control Group | Sham Comparator | Undergo all the same procedures as the EyeStim group except receive a sham NMES treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular electrical stimulation | 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. |
| 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. |
| 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 | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Ngo, MD | Brooks Rehabilitation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooks Rehabilitation | Jacksonville | Florida | 32216 | United States |
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| ID | Term |
|---|---|
| D001763 | Blepharoptosis |
| D000092164 | Lagophthalmos |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D005132 | Eye Manifestations |
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Active treatment vs. Sham control
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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.
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| Sham neuromuscular electrical stimulation | 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. |
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Measure of eyelid function in participants with CN III or CN VII palsy
| Within 1 week of last treatment session. |
| 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. |