A Novel Treatment Using Neuromuscular Electrical Stimulation to Improve Eyelid Function in Patients With CN III and CN VII Palsy.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Brooks Rehabilitation
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Marginal reflex distance-1 (MRD-1)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
EyeStim Group
Receive an active NMES treatment to the targeted muscles controlling eyelid function.
Intervention: Neuromuscular electrical stimulation (Device)
Control Group
Undergo all the same procedures as the EyeStim group except receive a sham NMES treatment.
Intervention: Sham neuromuscular electrical stimulation (Device)
Outcomes
Primary Outcomes
Marginal reflex distance-1 (MRD-1)
Time Frame: Within 1 week of last treatment session.
Measure of eyelid function for participants with CN III or CN VII palsy
Palpebral fissure height
Time Frame: Within 1 week of last treatment session.
Measure of eyelid function for participants with CN III or CN VII palsy
Secondary Outcomes
- Upper eyelid crease distance(Within 1 week of last treatment session.)
- World Health Organization Quality of Life - BREF (WHOQOL-BREF)(Within 1 week of last treatment session.)