Acupuncture Therapy, Deglutition Disorders, Electroacupuncture, Stroke Sequelae
Conditions
Keywords
Stroke Sequelae, Deglutition Disorders, Acupuncture Therapy, Electroacupuncture
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.
Interventions
DEVICELow 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.
DEVICEMedium 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.
DEVICEHigh 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.
Sponsors
Kaili Chen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Water Swallow Test (WST) Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Penetration-Aspiration Scale (PAS) Score via VFSS | 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. |
| Hyolaryngeal excursion measured by Ultrasound | 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. |
| Changes in Fractional Anisotropy (FA) values of swallowing-related neural pathways | 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. |
Countries
China
Contacts
CONTACTkaili chen
Outcome results
None listed