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

Not Applicable

Terminated

• Conditions: Blepharoptosis; Lagophthalmos
• Interventions: Device: Neuromuscular electrical stimulation; Device: Sham neuromuscular electrical stimulation

• Registration Number: NCT03239418
• Lead Sponsor: Brooks Rehabilitation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-06
• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-08-01
• Study First Posted: 2017-08-04
• Primary Completion: 2019-10-16
• Study Completion: 2019-10-16
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EyeStim Group	Neuromuscular electrical stimulation	Receive an active NMES treatment to the targeted muscles controlling eyelid function.
Control Group	Sham neuromuscular electrical stimulation	Undergo all the same procedures as the EyeStim group except receive a sham NMES treatment.

Primary Outcome Measures

Name	Time	Method
Marginal reflex distance-1 (MRD-1)	Within 1 week of last treatment session.	Measure of eyelid function for participants with CN III or CN VII palsy
Palpebral fissure height	Within 1 week of last treatment session.	Measure of eyelid function for participants with CN III or CN VII palsy

Secondary Outcome Measures

Name	Time	Method
Upper eyelid crease distance	Within 1 week of last treatment session.	Measure of eyelid function in participants with CN III or CN VII palsy
World Health Organization Quality of Life - BREF (WHOQOL-BREF)	Within 1 week of last treatment session.	Measure of Quality of Life for participants with CN III or CN VII palsy

Trial Locations

Locations (1)

Brooks Rehabilitation; 🇺🇸 Jacksonville, Florida, United States