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

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ClinicalTrials.gov Identifier: NCT03239418
Recruitment Status : Recruiting
First Posted : August 4, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Blepharoptosis Lagophthalmos Device: Neuromuscular electrical stimulation Device: Sham neuromuscular electrical stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Active treatment vs. Sham control
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.
Primary Purpose: Treatment
Official Title: A Novel Treatment Using Neuromuscular Electrical Stimulation to Improve Eyelid Function in Patients With CN III and CN VII Palsy.
Actual Study Start Date : January 6, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

Arm Intervention/treatment
Experimental: EyeStim Group
Receive an active NMES treatment to the targeted muscles controlling eyelid function.
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 Comparator: Control Group
Undergo all the same procedures as the EyeStim group except receive a sham NMES treatment.
Device: 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.




Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. World Health Organization Quality of Life - BREF (WHOQOL-BREF) [ Time Frame: Within 1 week of last treatment session. ]
    Measure of Quality of Life for participants with CN III or CN VII palsy

  2. Upper eyelid crease distance [ Time Frame: Within 1 week of last treatment session. ]
    Measure of eyelid function in participants with CN III or CN VII palsy


Other Outcome Measures:
  1. Distance visual acuity [ Time Frame: Within 1 week of last treatment session. ]
    Measure of overall eye health and function

  2. Distance alternate cover test. [ Time Frame: Within 1 week of last treatment. ]
    Measure of overall eye health and function

  3. Pupil test [ Time Frame: Within 1 week of last treatment session. ]
    Measure of overall eye health and function

  4. Oculomotor exam [ Time Frame: Within 1 week of last treatment session. ]
    Measure of overall eye health and function in participants with CN III palsy

  5. Cornea, Static Asymmetry, Dynamic Function, Synkinesis Classification Scale (CADS). [ Time Frame: Within 1 week of last treatment session. ]
    Measure of ophthalmic involvement in facial function in participants with CN VII palsy



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03239418


Contacts
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Contact: Raine Osborne, DPT 904-345-6934 Raine.Osborne@Brooksrehab.org
Contact: Mallorey Smith 904-345-8970 Mallorey.Smith@Brooksrehab.org

Locations
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United States, Florida
Brooks Rehabilitation Recruiting
Jacksonville, Florida, United States, 32216
Contact: Raine Osborne, DPT    904-345-6934    Raine.Osborne@Brooksrehab.org   
Contact: Mallorey Smith    904-345-870    Mallorey.Smith@Brooksrehab.org   
Principal Investigator: Kenneth Ngo, MD         
Sub-Investigator: Connie Garces, DPT         
Sub-Investigator: Katelyn Jorden, OD         
Sub-Investigator: Sarah LaRosa, OT         
Sub-Investigator: Lindsie Coleman, OT         
Sub-Investigator: Raine Osborne, DPT         
Sub-Investigator: Mallorey Smith         
Sponsors and Collaborators
Brooks Rehabilitation
Investigators
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Principal Investigator: Kenneth Ngo, MD Brooks Rehabilitation

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Responsible Party: Brooks Rehabilitation
ClinicalTrials.gov Identifier: NCT03239418     History of Changes
Other Study ID Numbers: BRCRC2016_001
First Posted: August 4, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Brooks Rehabilitation:
NMES
Additional relevant MeSH terms:
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Blepharoptosis
Eyelid Diseases
Eye Diseases