TerminatedNot Applicable

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

Stopped: Lack of recruitment

United States26 participantsStarted 2017-01-06

Plain-language 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.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Marginal reflex distance-1 (MRD-1)

Timeframe: Within 1 week of last treatment session.

Palpebral fissure height

Timeframe: Within 1 week of last treatment session.

Trial details

NCT IDNCT03239418

SponsorBrooks Rehabilitation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-16

View on ClinicalTrials.gov More Blepharoptosis trials