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Набор скоро начнётся NCT06927336

The Study on the Efficacy of tDCS Stimulation of the Cerebellum Combined With XingNaoJing Injection in Patients With Consciousness Disorders After Cranial Injury

Фаза IV С лечением tDCS Cerebellum Brain Injury Disturbance of Consciousness

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: XinNaoJing injection, tDCS.
Кому может быть актуально
Состояния в реестре: tDCS, Cerebellum, Brain Injury, Disturbance of Consciousness. 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 →

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Обзор

The purpose of this study is to investigate the effect of tDCS stimulation of cerebellum combined with Xingnaojing on patients with disturbance of consciousness after craniocerebral injury, and to clarify the relationship between the following two points: (1) to clarify whether MMN, P300, fNIRS, BAEP, SEP can be used as objective indicators to distinguish VS from MCS. (2) To clarify the changes of consciousness level and brain function in DoC patients with craniocerebral injury treated with tDCS stimulation of cerebellum combined with Xingnaojing.

Вмешательства

  • Препарат XinNaoJing injection
    XingNaoJing injection is a kind of traditional Chinese medicine preparation, which has the effects of clearing heat and detoxifying, cooling blood and activating blood circulation, resuscitating the brain. In recent years, it has been often used in the treatment of related symptoms caused by qi and blood disturbance and cerebral blood stasis, and has achieved certain results. Xingnaojing injection contains Yujin to resuscitate phlegm, invigorate blood circulation and promote qi; Zhizi dissipates
  • Устройство tDCS
    tDCS stimulated the cerebellum for 20 minutes, once a day, 5 times a week, a total of 10 times, and the stimulation intensity was 2mA.

Первичные конечные точки

  • electroencephalogram [Срок оценки: From enrollment to the end of treatment at 2 weeks]
  • Oxygenated hemoglobin concentration (HbO) [Срок оценки: From enrollment to the end of treatment at 2 weeks]
Вторичные конечные точки (12)
  • RLA grading Scale [Срок оценки: From enrollment to the end of treatment at 2 weeks]
  • Glasgow Coma Scale (GCS) [Срок оценки: From enrollment to the end of treatment at 2 weeks]
  • Coma Recovery Scale-Revised (CRS-R) [Срок оценки: From enrollment to the end of treatment at 2 weeks]
  • FOUR Score (Full Outline of UnResponsiveness) [Срок оценки: From enrollment to the end of treatment at 2 weeks]
  • Nutritional Risk Screening (NRS 2002) [Срок оценки: From enrollment to the end of treatment at 2 weeks]
  • Thrombosis Risk Assessment Scale (Padua Risk Assessment Scale) [Срок оценки: From enrollment to the end of treatment at 2 weeks]
  • Functional Independence Measure (FIM) [Срок оценки: From enrollment to the end of treatment at 2 weeks]
  • Albumin [Срок оценки: From enrollment to the end of treatment at 2 weeks]
  • S100β [Срок оценки: From enrollment to the end of treatment at 2 weeks]
  • NSE (Neuron-Specific Enolase) [Срок оценки: From enrollment to the end of treatment at 2 weeks]
  • NFL (Neurofilament Light Chain) [Срок оценки: From enrollment to the end of treatment at 2 weeks]
  • Tau Protein [Срок оценки: From enrollment to the end of treatment at 2 weeks]

Критерии участия

Критерии включения

  • aged 18-80 years;
  • All patients met the diagnostic criteria of DoC;
  • more than 1 month after the initial head injury;
  • stable consciousness for at least 2 weeks before admission (no change in CRS-R total score);
  • no skull defect or large area of skull repair;
  • The legal representative authorized by the patient approved the experimental protocol and signed the informed consent form.

Критерии исключения

  • supratentorial abnormalities on computed tomography (CT) or magnetic resonance imaging (MRI) involving more than one third of the middle cerebral artery territory;
  • a life expectancy of less than 3 months or a follow-up of less than 3 months;
  • retention of intracranial metal objects, cranial debridement, or presence of cranial defects and any clinically significant or unstable medical diseases;
  • EEG recording with significant muscle artifacts and inhibitory bursts;
  • nonconvulsive status epilepticus; Periodic or burst rhythms evoked by stimulation;
  • disturbance of consciousness due to surgical injury or tumor.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Electroencephalography — Куньмин

Идентификаторы

NCT: NCT06927336 · Shen-PJ-Ke-2025-6

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗