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

Brooks Rehabilitation

Status: Terminated

Conditions: Blepharoptosis; Lagophthalmos

Treatments: Device: Sham neuromuscular electrical stimulation; Device: Neuromuscular electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03239418

BRCRC2016_001

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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26 participants in 2 patient groups

EyeStim Group

Experimental group

Description:

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

Treatment:

Device: Neuromuscular electrical stimulation

Control Group

Sham Comparator group

Description:

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

Treatment:

Device: Sham neuromuscular electrical stimulation

Sponsor of this trial

Lead Sponsor

Brooks Rehabilitation