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NCT Number: NCT07496762

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

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.

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Key information

Conditions

Stroke Sequelae Acupuncture Therapy Deglutition Disorders Digestive System Diseases Electroacupuncture Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

Location contact

kaili chen

CONTACT

[email protected]

+8619858165101

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Frequency EA

Device

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)

Medium Frequency EA

Device

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)

High Frequency EA

Device

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

kaili chen

CONTACT

[email protected]

+8619858165101

Sponsors and collaborators

Lead sponsor

Kaili Chen

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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