Effects of Different-Frequency Electroacupuncture on Suprahyoid Muscles in Post-Stroke Dysphagia: Efficacy and Neural Networks
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change in Water Swallow Test (WST) Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Low Frequency EA
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.
干预措施: Low Frequency EA (Device)
Medium Frequency EA
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.
干预措施: Medium Frequency EA (Device)
High Frequency EA
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.
干预措施: High Frequency EA (Device)
结局指标
主要结局
Change in Water Swallow Test (WST) Score
时间窗: 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.
次要结局
- 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))
研究者
Kaili Chen
resident physician
The Third Affiliated hospital of Zhejiang Chinese Medical University