NCT06922864尚未招募不适用
the Prediction Value of Combined Electroencephalographic and Electromyographic Response in Disorders of Consciousness
KY20242235jiangwen0 个研究点目标入组 36 人开始时间: 2025年4月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 主要终点
- the state of consciousness
研究概览
简要总结
The goal of this observation study is to learn about the prediction value of combined electroencephalographic and electromyographic response in disorders of consciousness.
The main ways of stimulation is thermal and itch. Six months after inclusion in the study, patients were classified according to the Glasgow Outcome Scale Extended, (GOSE).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Brain damage lasts 28 to 90 days.
- •It meets the diagnostic criteria of unresponsive arousal syndrome/vegetative state (UWS/VS) or microconscious state (MCS).
- •Diagnostic criteria for UWS/VS: loss of cognitive function and inability to execute commands; There is a sleep-wake cycle; Inability to understand or express language; The ability to open eyes automatically or in response to stimulation; Can be purposeless eye following movement; The functions of hypothalamus and brainstem were basically preserved.
- •MCS diagnostic criteria: simple instructions can be executed; Yes/no (whether correct or not) can be expressed by gesture or speech; Have an understandable language; Purposeful behavior (including activity or emotional response) with more than one can diagnose MCS.
- •All subjects' legal guardians sign informed consent forms.
排除标准
- •Spinal cord T1 and above plane injury, peripheral nerve injury and so on affect nerve conduction;
- •The impact of injury on palms and soles of feet;
- •History of developmental, psychiatric, or neurological disorders prior to brain injury.
- •Deep sedation within 72 hours, including the use of general anesthesia.
- •Increased intracranial pressure, liver/kidney failure, and hemodynamic instability within 72 hours.
- •Severe co-existing systemic diseases with limited life expectancy.
结局指标
主要结局
the state of consciousness
时间窗: 6 months
次要结局
- the score of GOSE(6 months)
研究者
KY20242235jiangwen
head of department
Xijing Hospital
相似试验
Unknown
不适用
Electroencephalograph for Detection of Acute Ischemic StrokeStrokeNCT01737723Neurokeeper Technologies20
尚未招募
不适用
HR-EEG Contribution in Prognostic Evaluation of Language Development in Children With ASDChild LanguageNeurocognitive DisordersLanguage DevelopmentAutism Spectrum DisorderNCT05586672Etablissement Public de Santé Barthélemy Durand120
招募中
不适用
Electroencephalography in the Management of Neuroelectric Stimulation in Patients With Severe Traumatic Brain InjuriesBrain InjuriesNCT06571032RenJi Hospital50
招募中
不适用
EEG Monitoring for Refractory Status EpilepticusStatus EpilepticusNCT04170491Barts & The London NHS Trust40
Unknown
不适用
Frontal Amplitude-integrated Electroencephalogram in Early Prognostication After Cardiac ArrestHeart ArrestNCT03154879Seoul St. Mary's Hospital500