Effects of Different-Frequency Electroacupuncture on Suprahyoid Muscles in Post-Stroke Dysphagia: Efficacy and Neural Networks

March 23, 2026 updated by: Kaili Chen
This randomized controlled study in patients with post-stroke dysphagia aims to determine the optimal stimulation frequency of electroacupuncture of the suprahyoid muscles and to elucidate the underlying neural mechanisms. Participants will be assigned to low-frequency (2 Hz), medium-frequency (50 Hz), or high-frequency (100 Hz) electroacupuncture groups. Therapeutic efficacy will be assessed using the Kubota water-drinking test, videofluoroscopic swallowing study (VFSS), and ultrasonography to identify the optimal frequency. In parallel, diffusion tensor imaging (DTI) will be used to evaluate changes in fiber connectivity between swallowing-related cortical regions (bilateral precentral gyrus, insula, supramarginal gyrus, and frontal lobe) and the medullary nucleus tractus solitarius, thereby exploring neural network remodeling and providing mechanistic evidence to inform clinical practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • The Third Affiliated hospital of Zhejiang Chinese Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis: Patients diagnosed with cerebral infarction confirmed by CT or MRI.
  • Dysphagia Screening: Presence of varying degrees of dysphagia as screened by the Water Swallow Test (WST).
  • Clinical Status: Conscious and stable vital signs, with the ability to cooperate with the treatment.
  • Age: Aged between 18 and 80 years.
  • Consent: Signed informed consent form obtained from the patient or their legal representative.

Exclusion Criteria:

  • Dysphagia Etiology: Patients with dysphagia caused by etiologies other than cerebral infarction.
  • MRI Contraindications: Patients with metal implants or pacemakers in the body (contraindications for MRI).
  • Bleeding Risk: Patients with bleeding tendencies or coagulation disorders.
  • Blood Pressure: Patients with uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 120 mmHg).
  • Organ Failure: Patients with severe failure of vital organs (e.g., heart, liver, or kidney failure).
  • Disease Severity: Patients with critical or life-threatening stroke conditions.
  • Cooperation: Patients unable to cooperate with the treatment due to severe cognitive impairment, aphasia, or other reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low Frequency EA
Participants will receive electroacupuncture on the suprahyoid muscles at a frequency of 2Hz. The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses.
Device: Low Frequency EA
Electroacupuncture will be applied to the suprahyoid muscles. The stimulation frequency will be set at 2 Hz (Low Frequency). The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses.
Other Names:
  • Electroacupuncture (2Hz)
Experimental: Medium Frequency EA
Participants will receive electroacupuncture on the suprahyoid muscles at a frequency of 50Hz.The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses.
Device: Medium Frequency EA
Electroacupuncture will be applied to the suprahyoid muscles. The stimulation frequency will be set at 50 Hz (Medium Frequency). The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses.
Other Names:
  • Electroacupuncture (50Hz)
Experimental: High Frequency EA
Participants will receive electroacupuncture on the suprahyoid muscles at a frequency of 100Hz. The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses.
Device: High Frequency EA
Electroacupuncture will be applied to the suprahyoid muscles. The stimulation frequency will be set at 100 Hz (High Frequency).The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses.
Other Names:
  • Electroacupuncture (100Hz)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Water Swallow Test (WST) Score
Time Frame: Baseline and Week 6 (End of treatment)
The WST is a screening tool for dysphagia. It assesses the ability to swallow water and the presence of coughing or choking. Scores range from 1 to 5, with higher scores indicating more severe dysphagia. Improvement is defined as a decrease in the WST score.
Baseline and Week 6 (End of treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Penetration-Aspiration Scale (PAS) Score via VFSS
Time Frame: Baseline and Week 6 (End of treatment)
The PAS is an 8-point scale used to describe the severity of penetration and aspiration events during a Videofluoroscopic Swallowing Study (VFSS). Lower scores indicate safer swallowing function.
Baseline and Week 6 (End of treatment)
Hyolaryngeal excursion measured by Ultrasound
Time Frame: Baseline and Week 6 (End of treatment)
B-mode ultrasound will be used to measure the anterior and superior displacement distance of the hyoid bone and larynx during swallowing. Greater displacement indicates better function of the suprahyoid muscles.
Baseline and Week 6 (End of treatment)
Changes in Fractional Anisotropy (FA) values of swallowing-related neural pathways
Time Frame: Baseline and Week 6 (End of treatment)
Diffusion Tensor Imaging (DTI) will be used to measure the Fractional Anisotropy (FA) values of white matter fiber tracts connecting the bilateral precentral gyrus, insula, supramarginal gyrus, frontal lobe, and the nucleus of the solitary tract. Higher FA values indicate better structural integrity of the neural network.
Baseline and Week 6 (End of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaili Chen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 21, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZSLL-KY-2025-132-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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