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

Kaili Chen

Status: Not yet enrolling

Conditions: Stroke Sequelae; Electroacupuncture; Acupuncture Therapy; Deglutition Disorders

Treatments: Device: Medium Frequency EA; Device: High Frequency EA; Device: Low Frequency EA

Study type: Interventional

Funder types: Other

Identifiers

NCT07496762

ZSLL-KY-2025-132-01

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Low Frequency EA

Experimental group

Description:

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.

Treatment:

Device: Low Frequency EA

Medium Frequency EA

Experimental group

Description:

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.

Treatment:

Device: Medium Frequency EA

High Frequency EA

Experimental group

Description:

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.

Treatment:

Device: High Frequency EA