BlepharoptosisEyeStimNCT03239418
NMES to Improve Eyelid Functions in Cranial Nerve (CN) III and VII Palsy
A study testing Neuromuscular electrical stimulation in people with Blepharoptosis and Lagophthalmos, run by Brooks Rehabilitation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Blepharoptosis, Lagophthalmos
- What is being tested?
- Neuromuscular electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2017to 16 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cranial nerve III (oculomotor nerve) and/or cranial nerve IV (facial nerve) palsy.
- Able to read and communicate in English.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Treatment Using Neuromuscular Electrical Stimulation to Improve Eyelid Function in Patients With CN III and CN VII Palsy.
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
- Being tested
- Neuromuscular electrical stimulation, Sham neuromuscular electrical stimulation
- Keywords
- NMES
- Medical subject headings
- Blepharoptosis, Lagophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulationDevice
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| EyeStim Group | Experimental | Receive an active NMES treatment to the targeted muscles controlling eyelid function. Receives: Device: Neuromuscular electrical stimulation |
| Control Group | Sham comparator | Undergo all the same procedures as the EyeStim group except receive a sham NMES treatment. Receives: Device: Sham neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal reflex distance-1 (MRD-1)
Measure of eyelid function for participants with CN III or CN VII palsy
Measured: Within 1 week of last treatment session.
Palpebral fissure height
Measure of eyelid function for participants with CN III or CN VII palsy
Measured: Within 1 week of last treatment session.
Secondary outcomes (2)
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Measure of Quality of Life for participants with CN III or CN VII palsy
Measured: Within 1 week of last treatment session.
Upper eyelid crease distance
Measure of eyelid function in participants with CN III or CN VII palsy
Measured: Within 1 week of last treatment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start6 Jan 2017
- Primary completion16 Oct 2019
- Study completion16 Oct 2019
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharoptosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active treatment vs. Sham control
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooks Rehabilitation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Ngo, MD, Principal investigator, Brooks Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239418
- Sponsor's protocol ID
- BRCRC2016_001
- Acronym
- EyeStim
- Status last verified
- Dec 2022
- First submitted
- 31 Jul 2017
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Treatment Using Neuromuscular Electrical Stimulation to Improve Eyelid Function in Patients With CN III and CN VII Palsy.
- ClinicalTrials.gov ID
- NCT03239418
- Acronym / sponsor ID
- EyeStim / BRCRC2016_001
- Conditions
- Blepharoptosis, Lagophthalmos
- Keywords
- NMES
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Brooks RehabilitationUniversity, hospital or other
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 16 Oct 2019 (actual)
- First posted
- 4 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Active treatment vs. Sham control
| Arm | Type | Receives |
|---|---|---|
| EyeStim Group | Experimental | Device: Neuromuscular electrical stimulationReceive an active NMES treatment to the targeted muscles controlling eyelid function. |
| Control Group | Sham comparator | Device: Sham neuromuscular electrical stimulationUndergo all the same procedures as the EyeStim group except receive a sham NMES treatment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cranial nerve III (oculomotor nerve) and/or cranial nerve IV (facial nerve) palsy.
- Able to read and communicate in English.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulationA 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. | Device | EyeStim Group |
| Sham neuromuscular electrical stimulationElectrodes 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. | Device | Control Group |
Primary outcome
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
2 secondary outcomes
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Time frame: Within 1 week of last treatment session.
Upper eyelid crease distance
Time frame: Within 1 week of last treatment session.
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Ngo, MD principal investigator
Brooks Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation in people with Blepharoptosis and Lagophthalmos, run by Brooks Rehabilitation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal reflex distance-1 (MRD-1) (time frame: Within 1 week of last treatment session.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.