Меню
Набор скоро начнётся NCT07496762

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

Без фазы С лечением Stroke Sequelae Deglutition Disorders Acupuncture Therapy Electroacupuncture

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Low Frequency EA, Medium Frequency EA, High Frequency EA.
Кому может быть актуально
Состояния в реестре: Stroke Sequelae, Deglutition Disorders, Acupuncture Therapy, Electroacupuncture. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

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.

Вмешательства

  • Устройство 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.
  • Устройство 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.
  • Устройство 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.

Первичные конечные точки

  • Change in Water Swallow Test (WST) Score [Срок оценки: Baseline and Week 6 (End of treatment)]
Вторичные конечные точки (3)
  • Change in Penetration-Aspiration Scale (PAS) Score via VFSS [Срок оценки: Baseline and Week 6 (End of treatment)]
  • Hyolaryngeal excursion measured by Ultrasound [Срок оценки: Baseline and Week 6 (End of treatment)]
  • Changes in Fractional Anisotropy (FA) values of swallowing-related neural pathways [Срок оценки: Baseline and Week 6 (End of treatment)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • the Third Affiliated Hospital of Zhejiang Chinese Medical University — Ханчжоу

Идентификаторы

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗