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Not yet recruiting NCT07496762

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

No phase Interventional Stroke Sequelae Deglutition Disorders Acupuncture Therapy Electroacupuncture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low Frequency EA, Medium Frequency EA, High Frequency EA.
Who it may be relevant to
Registry conditions: Stroke Sequelae, Deglutition Disorders, Acupuncture Therapy, Electroacupuncture. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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.
  • 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.
  • 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.

Primary outcome measures

  • Change in Water Swallow Test (WST) Score [Time frame: Baseline and Week 6 (End of treatment)]
Secondary outcome measures (3)
  • Change in Penetration-Aspiration Scale (PAS) Score via VFSS [Time frame: Baseline and Week 6 (End of treatment)]
  • Hyolaryngeal excursion measured by Ultrasound [Time frame: 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • the Third Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou

Identifiers

NCT: NCT07496762 · ZSLL-KY-2025-132-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗