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

NCT03239418 | Terminated FDA Device

• 1 other identifier: BRCRC2016_001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Blepharoptosis; Lagophthalmos

Keywords

NMES

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (2)

• World Health Organization Quality of Life - BREF (WHOQOL-BREF)

  Within 1 week of last treatment session.

• Upper eyelid crease distance

  Within 1 week of last treatment session.

Other Outcomes (5)

• Distance visual acuity

  Within 1 week of last treatment session.

• Distance alternate cover test.

  Within 1 week of last treatment.

• Pupil test

  Within 1 week of last treatment session.

Study Arms (2)

EyeStim Group

EXPERIMENTAL

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

Device: Neuromuscular electrical stimulation

Control Group

SHAM COMPARATOR

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

Device: Sham neuromuscular electrical stimulation

Interventions

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.

EyeStim Group

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.

Control Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cranial nerve III (oculomotor nerve) and/or cranial nerve IV (facial nerve) palsy.
• Able to read and communicate in English.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brooks Rehabilitation: lead

Study Sites (1)

Brooks Rehabilitation

Jacksonville, Florida, 32216, United States

Location

MeSH Terms

Conditions

Blepharoptosis; Lagophthalmos

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Eye Manifestations

Study Officials

• Kenneth Ngo, MD

  Brooks Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Active treatment vs. Sham control

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 4, 2017
• Study Start: January 6, 2017
• Primary Completion: October 16, 2019
• Study Completion: October 16, 2019
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)