The Safety and Efficacy of Median Nerve Electrical Stimulation for Improving Neurological Function Prognosis in Patients With Cardiac Arrest

Официальное название

The Safety and Efficacy of Median Nerve Electrical Stimulation for Improving Neurological Function Prognosis in Patients With Cardiac Arrest: A Multicenter, Prospective, Randomized Controlled Study

Обзор

Median nerve stimulation (MNS), a non-invasive brain stimulation technique, has been widely adopted in clinical arousal therapies and multiple clinical investigations have attested to the efficacy of this technique; nevertheless, evidence concerning the application of MNS in improving the neurological prognosis of patients with return of spontaneous circulation (ROSC) following cardiac arrest (CA) remains scarce. The current study endeavors to assess the safety and efficacy of MNS treatment in enhancing the neurological prognosis of CA patients after ROSC and it is designed as a multicenter, prospective, randomized controlled trial with an estimated sample size of 400 patients. Eligible patients will be randomly allocated in a 1:1 ratio to either receive MNS treatment or sham stimulation treatment for 8 hours per day for 14 consecutive days and the primary outcome measure is the proportion of patients in each group with a Cerebral Performance Category (CPC) score ranging from 1 to 2, 6 months after randomization, which will help to determine the effectiveness of MNS in providing neuroprotection for patients with ROSC after CA.

Вмешательства

• Устройство MNS
  The MNS treatment group use the NeuroTrac™ Multi-TENS transcutaneous electrical stimulator to provide an asymmetric biphasic pulse train with a frequency of 35 Hz, an amplitude of 20 mA and a pulse width of 300 ms, which is on for 20 seconds and off for 50 seconds. The treatment lasts for 8 hours per day and the treatment course lasts for one week.
• Устройство Sham stimulation
  The sham stimulation treatment group utilized the same stimulation device and was subjected to a safe yet ineffective stimulation protocol for sham stimulation. The treatment lasts for 8 hours per day and the treatment course lasts for 14 days.

Первичные конечные точки

• The proportion of patients with a CPC score of 1-2 [Срок оценки: 180 days]

Критерии участия

Критерии включения

• Age ≥ 18 years old.
• Hemodynamics remains continuously stable for ≥ 7 days.
• There is still a lack of purposeful movements after the return of spontaneous circulation following cardiopulmonary resuscitation.
• Advanced life support is provided within 6 hours after the return of spontaneous circulation (ROSC).

Критерии исключения

• Patients with hemodynamic instability.
• Pregnant patients.
• Those who have abnormal anatomical structures on the median nerve conduction pathway and are unable to receive electrical stimulation.
• Patients with a confirmed history of epilepsy before admission or during hospitalization.
• Patients with severe arrhythmia or those who have pacemakers implanted.
• Patients whose family members do not agree to their enrollment in the study.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Chao-Yang Hospital — Пекин

Идентификаторы

NCT: NCT06696690 · 2024-6-7-3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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