رادار التجارب AI | ||
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حالة التجربة السريرية NCT07496762 لـ عواقب السكتة الدماغية، اضطرابات البلع، علاج الوخز بالإبر، العلاج بالإبر الكهربائية هي لم يبدأ القبول بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
Effects of Different-Frequency Electroacupuncture on Suprahyoid Muscles in Post-Stroke Dysphagia: Efficacy and Neural Networks ٩٠ عشوائية
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT07496762 هي دراسة تدخُّلية لـعواقب السكتة الدماغية، اضطرابات البلع، علاج الوخز بالإبر، العلاج بالإبر الكهربائية وهي لم يبدأ القبول بعد. من المقرر أن يبدأ التسجيل في ٤ ذو القعدة ١٤٤٧ هـ لتجنيد ٩٠ مشاركًا. يقودها Kaili Chen، ومن المتوقع اكتمالها بحلول ٥ شعبان ١٤٥٠ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٨ شوال ١٤٤٧ هـ.
الملخص
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-d...عرض المزيد
العنوان الرسمي
Effects of Different-Frequency Electroacupuncture on Suprahyoid Muscles in Post-Stroke Dysphagia: Efficacy and Neural Networks
الحالات الطبية
عواقب السكتة الدماغيةاضطرابات البلععلاج الوخز بالإبرالعلاج بالإبر الكهربائيةمعرّفات دراسة أخرى
- ZSLL-KY-2025-132-01
NCT معرّف
تاريخ البدء (فعلي)
2026-04-21
آخر تحديث مُنشور
2026-03-27
تاريخ الاكتمال (المقدر)
2028-12-21
عدد المشاركين المخطط لهم
٩٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
لم يبدأ القبول بعد
الكلمات الرئيسية
Stroke Sequelae
Deglutition Disorders
Acupuncture Therapy
Electroacupuncture
Deglutition Disorders
Acupuncture Therapy
Electroacupuncture
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
مزدوج
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةLow 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. | 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. |
تجريبيةMedium 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. | 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. |
تجريبيةHigh 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. | 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. |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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) |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Change in Penetration-Aspiration Scale (PAS) Score via VFSS | 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. | Baseline and Week 6 (End of treatment) |
Hyolaryngeal excursion measured by Ultrasound | 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. | Baseline and Week 6 (End of treatment) |
Changes in Fractional Anisotropy (FA) values of swallowing-related neural pathways | 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. | Baseline and Week 6 (End of treatment) |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
- 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.
- 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.
Kaili Chenالجهة المسؤولة عن الدراسة
Kaili Chen, الراعي-المحقق, resident physician, The Third Affiliated hospital of Zhejiang Chinese Medical University
جهة اتصال مركزية للدراسة
جهة اتصال: kaili chen, +8619858165101, [email protected]
1 مواقع الدراسة في 1 بلدان
Zhejiang
the Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, 310000, China
kaili chen, جهة اتصال, +8619858165101, [email protected]