TaVNS for Acute Intracerebral Hemorrhage

Официальное название

Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Acute Intracerebral Hemorrhage

Обзор

This study aims to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in patients with acute intracerebral hemorrhage (ICH). The taVNS intervention will be delivered using the BS-TVNS800-1 transcutaneous electrical stimulation therapy device (KERFUN, Shanxi, China). A total of 186 patients will be randomly assigned in a 1:1 ratio to either the taVNS group or the sham-taVNS group. The primary outcome is the relative volume of perihematoma edema assessed on day 10-14 after randomization. Adverse events associated with taVNS therapy will be systematically evaluated to assess its safety profile.

Вмешательства

• Устройство transcutaneous auricular vagus nerve stimulation device
  Place the stimulation device on the left auricle and set the stimulation parameters according to the following conditions: a. Waveform: biphase, square wave; b. Wave width: 200 μs; c. Frequency: Alternating between low frequency (4 Hz for 4 s), high frequency (40 Hz for 8 s), and a 4 s pause; d. Intensity: The maximum intensity that induces the strongest sensation the individual can tolerate without causing pain, usually 1.5-3.5 mA; e. Treatment duration: Each treatment lasted 30 minutes, twice
• Устройство Sham device
  The sham taVNS group received the same parameters with a current intensity of 0.06 mA.

Первичные конечные точки

• Volume of perihematoma edema assessed by CT [Срок оценки: Day 10-14 after randomization]

Вторичные конечные точки (12)

• Autonomic activity assessed by heart rate variability [Срок оценки: Day 10-14 after randomization]
• Autonomic activity assessed by baroreflex sensitivity [Срок оценки: Day 10-14 after randomization]
• National Institutes of Health stroke scale (NIHSS) [Срок оценки: Day 10-14 after randomization]
• GCS (Glasgow Coma Scale) [Срок оценки: Day 10-14 after randomization]
• MMSE (Mini-Mental State Examination) [Срок оценки: Day 10-14 after randomization]
• MoCA (Montreal Cognitive Assessment) [Срок оценки: Day 10-14 after randomization]
• PHQ-9 (Patient Health Questionnaire-9) [Срок оценки: Day 10-14 after randomization]
• 90-day National Institutes of Health stroke scale (NIHSS) [Срок оценки: 90 ± 7 days after randomization]
• 90-day modified Rankin Scale (mRS) [Срок оценки: 90 ± 7 days after randomization]
• 90-day EQ-5D (EuroQol 5-Dimension Questionnaire) score [Срок оценки: 90 ± 7 days after randomization]
• 90-day GCS (Glasgow Coma Scale) [Срок оценки: 90 ± 7 days after randomization]
• 90-day MMSE (Mini-Mental State Examination) [Срок оценки: 90 ± 7 days after randomization]

Критерии участия

Критерии включения

• Patients with spontaneous supratentorial intracerebral hemorrhage.
• Age between 18 and 80 years.
• Onset within 72 hours.
• Hematoma volume between 5 and 40 mL.
• Glasgow Coma Scale (GCS) score greater than 8.
• Written informed consent obtained from the patient or their legal representative.

Критерии исключения

• Secondary intracerebral hemorrhage (e.g., traumatic, tumor-related, vascular malformation, aneurysm, or coagulopathy-related).
• Primary intraventricular hemorrhage.
• Parenchymal hemorrhage that ruptures into the ventricles, with blood completely filling one lateral ventricle, the third ventricle, the fourth ventricle or more than half of both lateral ventricles.
• Progressive neurological or other severe diseases.
• Planned surgical treatment within 24 hours.
• Pre-existing disability caused by previous illnesses: Modified Rankin Scale (mRS) score ≥ 3.
• Patients with severe cardiomyopathy, heart failure, pacemaker implantation, atrial fibrillation, frequent premature beats, second-degree or higher atrioventricular block, or other severe arrhythmias.
• Severe pulmonary disease, liver disease, renal insufficiency (glomerular filtration rate < 30 mL/min), active gastrointestinal bleeding, or malignant tumors with an expected survival of less than 3 months.
• Patients with hyperthyroidism, hypothyroidism, syncope, epilepsy, multiple sclerosis, Parkinson's disease, multiple system atrophy, or other known disorders affecting autonomic nervous function.
• Use of medications that interfere with autonomic function (e.g., beta-blockers, theophylline, tricyclic antidepressants, or steroids) within 7 days before screening.
• Patients who cannot tolerate taVNS.
• Congenital or acquired ear abnormalities preventing taVNS treatment.
• Inability to comply with 10 days of treatment.
• Pregnancy or within 30 days of delivery.
• Participation in another interventional clinical trial.
• Inability to obtain written informed consent from the participant or their legal representative.

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

• Beijing Tiantan Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT06918964 · KangKJ

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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