Research on Binaural Synchronous Vagus Nerve Regulation of Sensorimotor Disorders After Cerebral Infarction

Обзор

The aim of this study is to determine the efficacy and safety of binaural synchronous vagus nerve regulation in the treatment of patients with sensory and motor dysfunction after cerebral infarction through a randomized controlled clinical study, and to provide high-quality evidence support for binaural synchronous vagus nerve regulation in the treatment of cerebral infarction.

Подробное описание

The research subjects were first-onset cerebral infarction and were recruited at the Affiliated Rehabilitation Hospital of Nanchang University (the Fourth Affiliated Hospital). Based on the estimated sample size, a total of 40 patients were included in this study. The randomization grouping protocol divided 40 patients into the experimental group and the control group in a 1:1 ratio. Experimental group: Received synchronous vagus nerve regulation in both ears. Control group: Received false stimulation. The randomization procedure was carried out by independent statisticians who were not involved in the implementation and statistics of the study. The trial secretary placed the generated random numbers and groups respectively into opaque envelopes. After the patients were confirmed to be included in the group, the project leader opened the envelopes numbered in sequence to complete the grouping. This study was A double-blind design, using a unified binaural vagus nerve electrical stimulation device (JY-VNS-200, Jiangxi Jingyi Medical Technology Company Limited.). To achieve researcher blindness, the device was preset in A/B mode, with one mode being true stimulation and the other mode being false stimulation. After the experiment, unblinding was performed by personnel who were not involved in the study. During the experiment, the patients did not know whether they were receiving actual treatment or a placebo. The patients were blind. Meanwhile, the evaluators and statistical analysts were unaware of the grouping of the patients.

Вмешательства

• Устройство transcutaneous auriculai vagus nerve stimulation
  During bi-ear synchronous vagus nerve stimulation, the patient was positioned in a supine position. Two stimulating electrodes were placed bilaterally in the concha cymba and concha cavum of the ears. The patient received treatment for 30 minutes per session, once daily, 5 days per week, for a total of 4 weeks. Following each treatment session, the device was disinfected with 75% alcohol.

Первичные конечные точки

• Motor function score [Срок оценки: Before the start of treatment, the last week before the end of treatment, and the third month after the onset of the disease]
• Overall functional score [Срок оценки: Before the start of treatment, the last week before the end of treatment, and the third month after the onset of the disease]
• Transcranial Magnetic Stimulation combined with Electroencephalography（TMS-EEG） [Срок оценки: Before the start of treatment, the last week before the end of treatment, and the third month after the onset of the disease]
• Sensory function score [Срок оценки: Before the start of treatment, the last week before the end of treatment, and the third month after the onset of the disease]

Вторичные конечные точки (1)

• Cognitive function score [Срок оценки: Before the start of treatment]

Критерии участия

Критерии включения

• Patients with first-episode ischemic stroke within 7 to 14 days of onset;
• Be over 18 years old;
• The skin at the irritated area remains intact;
• The informed consent form has been signed.

Критерии исключения

• Severe cognitive dysfunction (Mini-Mental State Examination≥19);
• Peripheral limb movement limiting factors (fractures);
• History of major neurological and mental disorders in the past;
• Uncontrollable limb and facial muscle twitching, and spontaneous profuse sweating;
• Intracranial shunt pumps, metal implants

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Fourth Affiliated Rehabilitation Hospital of Nanchang University — Nanchang

Идентификаторы

NCT: NCT07081568 · SFYLL-KY-PJ-2025-004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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