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

Blepharoptosis Clinical Trial

— EyeStim  

Official title:

A Novel Treatment Using Neuromuscular Electrical Stimulation to Improve Eyelid Function in Patients With CN III and CN VII Palsy.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03239418
• Other study ID #: BRCRC2016_001
• Status: Terminated
• Phase: N/A
• Start date: January 6, 2017
• Est. completion date: October 16, 2019

Study information

• Verified date: December 2022
• Source: Brooks Rehabilitation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: October 16, 2019
• Est. primary completion date: October 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blepharoptosis
• Lagophthalmos

Intervention

Device:
• Neuromuscular electrical stimulation
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.
• Sham neuromuscular electrical stimulation
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.

Locations

Country	Name	City	State
United States	Brooks Rehabilitation	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Brooks Rehabilitation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Distance visual acuity	Measure of overall eye health and function	Within 1 week of last treatment session.
Other	Distance alternate cover test.	Measure of overall eye health and function	Within 1 week of last treatment.
Other	Pupil test	Measure of overall eye health and function	Within 1 week of last treatment session.
Other	Oculomotor exam	Measure of overall eye health and function in participants with CN III palsy	Within 1 week of last treatment session.
Other	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.
Primary	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.
Primary	Palpebral fissure height	Measure of eyelid function for participants with CN III or CN VII palsy	Within 1 week of last treatment session.
Secondary	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.
Secondary	Upper eyelid crease distance	Measure of eyelid function in participants with CN III or CN VII palsy	Within 1 week of last treatment session.