Effects of Different-Frequency Electroacupuncture on Suprahyoid Muscles in Post-Stroke Dysphagia: Efficacy and Neural Networks
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2026
CompletedFirst Posted
Study publicly available on registry
March 27, 2026
CompletedStudy Start
First participant enrolled
April 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 21, 2028
March 27, 2026
March 1, 2026
2.7 years
March 23, 2026
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Water Swallow Test (WST) Score
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 Outcomes (3)
Change in Penetration-Aspiration Scale (PAS) Score via VFSS
Baseline and Week 6 (End of treatment)
Hyolaryngeal excursion measured by Ultrasound
Baseline and Week 6 (End of treatment)
Changes in Fractional Anisotropy (FA) values of swallowing-related neural pathways
Baseline and Week 6 (End of treatment)
Study Arms (3)
Low Frequency EA
EXPERIMENTALParticipants 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.
Medium Frequency EA
EXPERIMENTALParticipants 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.
High Frequency EA
EXPERIMENTALParticipants 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kaili Chenlead
Study Sites (1)
the Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- resident physician
Study Record Dates
First Submitted
March 23, 2026
First Posted
March 27, 2026
Study Start
April 21, 2026
Primary Completion (Estimated)
December 21, 2028
Study Completion (Estimated)
December 21, 2028
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share