DysphagiaNCT07415785

NMES Plus Conventional Therapy for Stroke Dysphagia

A study testing neuromuscular electrical stimulation and traditional dysphagia therapy in people with Dysphagia and Stroke, run by Chiayi Christian Hospital at 1 site in Taiwan.

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

Aim: The aim of this study is to investigate the effect of neuromuscular electrical stimulation (NMES) combined with traditional dysphagia therapy (TDT) in acute/subacute stroke patients with dysphagia. Methods: We design a randomized controlled trial to conduct this study. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Dysphagia, Stroke
What is being tested?: neuromuscular electrical stimulation and traditional dysphagia therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteTaiwan
Study dates: 25 Sep 2023to 29 Jul 2025
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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Acute or subacute stroke;
Presence of dysphagia;
Receiving tube feeding;
Age between 20 and 80 years;
Able to understand and follow simple instructions with prompts, and able to respond to questions either verbally or through gestures.

Who cannot join

Pre-existing dysphagia prior to the current stroke;
Other neurological diseases (e.g., dementia);
Unstable cardiopulmonary function;
Severe psychiatric disorders;
Head and neck cancer, history of surgical tissue removal, or radiation therapy;
Prior participation in swallowing training before this study;
Presence of implanted electronic devices (e.g., pacemakers, cochlear implants);
Impaired consciousness.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Chiayi Christian Hospital
Chiayi City

Other trials in Taiwan

About this study

Official title: Efficacy of Neuromuscular Electrical Stimulation Plus Conventional Dysphagia Therapy in Acute and Subacute Stroke Patients: A Randomized Controlled Trial

Methods: We design a randomized controlled trial to conduct this study. A total of 100 participants with stroke-induced dysphagia are included and randomly assigned to two groups: NMES+TDT and sham NMES+TDT. Participants receive a two-week training protocol, 5 times a week, with each session lasting 30 minutes. Clinical outcomes are recorded at baseline and at 1-, 2-, and 4-week follow-up visits. These outcomes include the Function Oral Intake Scale (FOIS), Eating Assessment Tool (EAT-10), and Swallowing-Related Quality of Life (Taiwan version).

Expected results: We hope that the effectiveness of NMES in treating stroke-induced dysphagia can be clarified. This information can be provided when treating patients with stroke-induced dysphagia.

Conditions: Dysphagia, Stroke
Being tested: neuromuscular electrical stimulation, traditional dysphagia therapy
Medical subject headings: Deglutition Disorders, Stroke

What participants receive

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

neuromuscular electrical stimulationOther
This intervention is distinguished from other clinical interventions by the combination of neuromuscular electrical stimulation (NMES) with conventional dysphagia therapy in acute and subacute stroke patients. Unlike studies that employ either NMES or traditional therapy alone, this protocol integrates both approaches to potentially enhance swallowing function through simultaneous neuromuscular activation and task-specific swallowing exercises.
traditional dysphagia therapyOther
traditional dysphagia therapy

Study groups in NCT07415785
Study group	Role	What they receive
Sham neuromuscular electrical stimulation combined with traditional dysphagia therapy	Experimental	Traditional dysphagia therapy combined with sham neuromuscular electrical stimulation electrical, in which stimulation intensity was set at the minimum level (1 mA), with a frequency of 80 Hz and a pulse duration of 700 μs. Receives: Other: traditional dysphagia therapy
neuromuscular electrical stimulation combined with traditional dysphagia therapy	Experimental	Not described Receives: Other: neuromuscular electrical stimulation

What is being measured

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

Functional Oral Intake
Swallowing function was assessed using the Functional Oral Intake Scale (FOIS), an ordinal scale that reflects the functional level of oral intake in patients with dysphagia.
Measured: The time frame included four assessment points: at baseline, after 1 week of treatment, after 2 weeks of treatment, and at a 2-week follow-up.
Swallowing function assessment
Swallowing function was assessed using the self-administered Eating Assessment Tool (EAT-10, Chinese version).
Measured: The time frame included four assessment points: at baseline, after 1 week of treatment, after 2 weeks of treatment, and at a 2-week follow-up.

Secondary outcomes (1)

Swallowing quality of life
This questionnaire is designed to investigate the impact of dysphagia caused by various conditions on quality of life and is applicable to all populations with swallowing difficulties. The Swallowing Quality of Life Questionnaire (SWAL-QOL) consists of 44 items across 11 domains, including: burden, eating duration, eating desire, symptom frequency, food selection, communication, fear, mental health, social functioning, fatigue, and sleep.
Measured: The time frame included four assessment points: at baseline, after 1 week of treatment, after 2 weeks of treatment, and at a 2-week follow-up.

Timeline

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

25 Sep 202329 Jul 2025

First posted17 Feb 2026
Study start25 Sep 2023
Primary completion29 Jul 2025
Study completion29 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DysphagiaStudies 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
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07415785
Sponsor's protocol ID: IRB2023055
Status last verified: Feb 2026
First submitted: 10 Feb 2026
Last updated: 17 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
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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All Dysphagia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Neuromuscular Electrical Stimulation Plus Conventional Dysphagia Therapy in Acute and Subacute Stroke Patients: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07415785
Acronym / sponsor ID: IRB2023055
Conditions: Dysphagia, Stroke
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Chiayi Christian HospitalUniversity, hospital or other
Study start: 25 Sep 2023 (actual)
Primary completion: 29 Jul 2025 (actual)
Study completion: 29 Jul 2025 (actual)
First posted: 17 Feb 2026 (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.

Expected results: We hope that the effectiveness of NMES in treating stroke-induced dysphagia can be clarified. This information can be provided when treating patients with stroke-induced dysphagia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sham neuromuscular electrical stimulation combined with traditional dysphagia therapy	Experimental	Other: traditional dysphagia therapyTraditional dysphagia therapy combined with sham neuromuscular electrical stimulation electrical, in which stimulation intensity was set at the minimum level (1 mA), with a frequency of 80 Hz and a pulse duration of 700 μs.
neuromuscular electrical stimulation combined with traditional dysphagia therapy	Experimental	Other: neuromuscular electrical stimulation

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Acute or subacute stroke;
Presence of dysphagia;
Receiving tube feeding;
Age between 20 and 80 years;
Able to understand and follow simple instructions with prompts, and able to respond to questions either verbally or through gestures.

Key exclusion criteria (8 listed)

Pre-existing dysphagia prior to the current stroke;
Other neurological diseases (e.g., dementia);
Unstable cardiopulmonary function;
Severe psychiatric disorders;
Head and neck cancer, history of surgical tissue removal, or radiation therapy;

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 stimulationThis intervention is distinguished from other clinical interventions by the combination of neuromuscular electrical stimulation (NMES) with conventional dysphagia therapy in acute and subacute stroke patients. Unlike studies that employ either NMES or traditional therapy alone, this protocol integrates both approaches to potentially enhance swallowing function through simultaneous neuromuscular activation and task-specific swallowing exercises.	Other	neuromuscular electrical stimulation combined with traditional dysphagia therapy
traditional dysphagia therapytraditional dysphagia therapy	Other	Sham neuromuscular electrical stimulation combined with traditional dysphagia therapy

Primary outcome

Functional Oral Intake
Time frame: The time frame included four assessment points: at baseline, after 1 week of treatment, after 2 weeks of treatment, and at a 2-week follow-up.
Swallowing function was assessed using the Functional Oral Intake Scale (FOIS), an ordinal scale that reflects the functional level of oral intake in patients with dysphagia.
Swallowing function assessment
Time frame: The time frame included four assessment points: at baseline, after 1 week of treatment, after 2 weeks of treatment, and at a 2-week follow-up.
Swallowing function was assessed using the self-administered Eating Assessment Tool (EAT-10, Chinese version).

1 secondary outcome

Swallowing quality of life
Time frame: The time frame included four assessment points: at baseline, after 1 week of treatment, after 2 weeks of treatment, and at a 2-week follow-up.

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 17 Feb 2026.
Individual participant dataSharing planned: No

Related trials for Dysphagia

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Active, not recruitingObservational study
Dexmedetomidine Nasal Spray and Postoperative Sore Throat After Bronchoscopy
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 and traditional dysphagia therapy in people with Dysphagia and Stroke, run by Chiayi Christian Hospital at 1 site in Taiwan.

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 5 inclusion and 8 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 17 Feb 2026. 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 Taiwan. 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?

Functional Oral Intake (time frame: The time frame included four assessment points: at baseline, after 1 week of treatment, after 2 weeks of treatment, and at a 2-week follow-up.). 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 NCT07415785.

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 17 Feb 2026.