Stroke, IschemicNMESNCT05102877

Sensory Versus Motor Level Neuromuscular Electrical Stimulation

A study testing Neuromuscular electrical stimulation in people with Stroke, Ischemic, run by Casa Colina Hospital and Centers for Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Dysphagia is a serious cause of morbidity and mortality in stroke survivors. Electrical stimulation is often included as part of the treatment plan for dysphagia, and can be applied at a sensory or motor level intensity. However, evidence to support these different modes of stimulation is lacking. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Stroke, Ischemic
What is being tested?: Neuromuscular electrical stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 19 Sep 2018to 30 Nov 2020
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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18-80
acute ischemic CVA within the first month and confirmed by MRI.
Diagnosis of dysphagia will be obtained by bedside swallowing exam and MBS/FEES studies.

Who cannot join

patients who have contraindications for electrical stimulation (malignancy, DVT/thrombophlebitis, hemorrhagic conditions, pregnancy, pacemaker or other electrical hardware)
known premorbid swallowing disorders
GERD
dementia or psychiatric disorder
bilateral cerebral involvement
contraindications for FEES/MBS (infectious disease such as HIV, HCV, HBV, nasal obstruction, decompensated heart disease, risk of bleeding such as active ulcers, allergy to contrast).

Trial locations and contacts

1 site in 1 country.

United States1 site

Casa Colina Hospital and Centers for Healthcare
Pomona, California, 91769

Other trials in United States

About this study

Official title: The Effect of Sensory Level Versus Motor Level Electrical Stimulation of Pharyngeal Muscles in Acute Stroke Patients With Dysphagia

Read the detailed description

Objective: Dysphagia is a serious cause of morbidity and mortality in stroke survivors. Electrical stimulation is often included as part of the treatment plan for dysphagia, and can be applied at a sensory or motor level intensity. However, evidence to support sensory versus motor stimulation is lacking. This study compares the effect of sensory and motor stimulation on post-stroke dysphagia.

Design: Randomized controlled trial

Setting: Inpatient rehabilitation facility.

Participants: Participants (50-75 years of age) who had dysphagia caused by a stroke within 6 months prior to enrollment were included. Participants were excluded if they had a contraindication for electrical stimulation, previous stroke, psychiatric disorder, contraindications for MBS, or pre-stroke swallowing disorders.

Interventions: Each patient received ten, 45-minute anterior neck sensory or motor level electrical stimulation sessions in addition to standard speech therapy. Motor stimulation was administered as a stimulus intensity sufficient to produce muscle contractions. Sensory stimulation was defined as the threshold when the patient feels a tingling sensation on their skin (approximately 4-5mA).

Main Outcome Measures: Swallow FIM, National Outcome Measurement System (NOMS), Dysphagia Outcome Severity Scale (DOSS), and change in modified diet.

Conditions: Stroke, Ischemic
Being tested: Neuromuscular electrical stimulation
Keywords: Dysphagia, Swallow, Stimulation
Medical subject headings: Ischemic Stroke, Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neuromuscular electrical stimulationDevice
Motor stimulation was administered at an intensity sufficient to produce muscle contractions. Sensory stimulation was defined as the threshold when the patient feels a tingling sensation on their skin.

Study groups in NCT05102877
Study group	Role	What they receive
Sensory level stimulation	Experimental	ten, 45-minute anterior neck sensory level electrical stimulation sessions in addition to traditional dysphagia therapy. Receives: Device: Neuromuscular electrical stimulation
Motor level stimulation	Experimental	ten, 45-minute anterior neck sensory level electrical stimulation sessions in addition to traditional dysphagia therapy. Receives: Device: Neuromuscular electrical stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Swallow Functional Assessment Measure
7 point swallow scale the Functional oral intake scale (FOIS) lowest score = 1; highest = 7.
Measured: up to 2 months
Change in Dysphagia outcome Severity Scale
seven-point functional outcome scale designed to assess dysphagia severity on the MBSS, lowest score = 1; highest = 7.
Measured: up to 2 months

Secondary outcomes (2)

Change in PenAsp
Evaluates the depth response and clearance of material entering into the airway, lowest score = 8; highest =1.
Measured: up to 2 months
Change in Swal-Qol
93-item outcome tool 24 was used to determine impact on quality-of-life and quality-of-care. Each item has a 5 point likert scale.
Measured: up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Sep 201830 Nov 2020

First posted2 Nov 2021
Study start19 Sep 2018
Primary completion30 Oct 2020
Study completion30 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stroke, IschemicStudies 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: Randomized trial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05102877
Sponsor's protocol ID: NMES 1.1
Acronym: NMES
Status last verified: Aug 2022
First submitted: 12 Oct 2021
Last updated: 8 Aug 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
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Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
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Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
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MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia

All Stroke, Ischemic trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Sensory Level Versus Motor Level Electrical Stimulation of Pharyngeal Muscles in Acute Stroke Patients With Dysphagia
ClinicalTrials.gov ID: NCT05102877
Acronym / sponsor ID: NMES / NMES 1.1
Conditions: Stroke, Ischemic
Keywords: Dysphagia, Swallow, Stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Casa Colina Hospital and Centers for HealthcareUniversity, hospital or other
Study start: 19 Sep 2018 (actual)
Primary completion: 30 Oct 2020 (actual)
Study completion: 30 Nov 2020 (actual)
First posted: 2 Nov 2021 (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.

Detailed description

Design: Randomized controlled trial

Setting: Inpatient rehabilitation facility.

Main Outcome Measures: Swallow FIM, National Outcome Measurement System (NOMS), Dysphagia Outcome Severity Scale (DOSS), and change in modified diet.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized trial

Arm	Type	Receives
Sensory level stimulation	Experimental	Device: Neuromuscular electrical stimulationten, 45-minute anterior neck sensory level electrical stimulation sessions in addition to traditional dysphagia therapy.
Motor level stimulation	Experimental	Device: Neuromuscular electrical stimulationten, 45-minute anterior neck sensory level electrical stimulation sessions in addition to traditional dysphagia therapy.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

18-80
acute ischemic CVA within the first month and confirmed by MRI.
Diagnosis of dysphagia will be obtained by bedside swallowing exam and MBS/FEES studies.

Key exclusion criteria (6 listed)

patients who have contraindications for electrical stimulation (malignancy, DVT/thrombophlebitis, hemorrhagic conditions, pregnancy, pacemaker or other electrical hardware)
known premorbid swallowing disorders
GERD
dementia or psychiatric disorder
bilateral cerebral involvement

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 stimulationMotor stimulation was administered at an intensity sufficient to produce muscle contractions. Sensory stimulation was defined as the threshold when the patient feels a tingling sensation on their skin.	Device	Motor level stimulation, Sensory level stimulation

Primary outcome

Change in Swallow Functional Assessment Measure
Time frame: up to 2 months
7 point swallow scale the Functional oral intake scale (FOIS) lowest score = 1; highest = 7.
Change in Dysphagia outcome Severity Scale
Time frame: up to 2 months
seven-point functional outcome scale designed to assess dysphagia severity on the MBSS, lowest score = 1; highest = 7.

2 secondary outcomes

Change in PenAsp
Time frame: up to 2 months
Change in Swal-Qol
Time frame: up to 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
Individual participant dataSharing planned: No

Related trials for Stroke, Ischemic

Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia

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.

Emily R. Rosario, PhD principal investigator

Casa Colina Hospital and Centers for Healthcare

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 Stroke, Ischemic, run by Casa Colina Hospital and Centers for Healthcare 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 8 Aug 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in Swallow Functional Assessment Measure (time frame: up to 2 months). 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?

On the ClinicalTrials.gov record for NCT05102877.

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 8 Aug 2022.