Effects of Acoustic Stimuli in Patients With Disorders of Consciousness: An Electroencephalography and Neuroimaging Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- Glasgow Outcome Scale (GOS)
研究概览
简要总结
In recent years, promoting wakening attempts in patients with disorders of consciousness are increasing, but there are a lack of objective indicators to evaluate the efficacy and further researches on the brain mechanism during the wakening processing. So, the study first assessed the cerebral response during emotional acoustic stimuli with quantitative EEG and ERP(Event-related potential), and next, the investigators explored the relationship between brain activation and patients' recovery.
详细描述
Auditory stimuli have potential beneficial effects on cognitive functions and consciousness in patients with disorders of consciousness (DOC)，especially the emotional sound; however, precise and accurate quantitative indices to estimate cerebral activation to different auditory stimuli remain scarce. In this study, investigators assessed the response of different brain regions to three acoustic stimuli using quantitative electroencephalography (QEEG) and ERP(Event-related potential),and further investigated the predictive value of QEEG in the prognosis of DOC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Brain-damaged patients :
- •Inclusion Criteria:
- •Disorders of consciousness (Traumatic brain injury, stroke or anoxic encephalopathy)
- •Coma diagnosis (Plum and Posner, 1966), vegetative state (Task Force, 1994) or minimally conscious state (Giacino, Ashwal et al. 2002)
- •Lack of autonomic crisis since one week minimum
- •Medical condition considered stable
- •Patients who do not present hearing loss. Peaks I and II of Brainstem Auditory Evoked Potentials (BAEP) will be normal.
排除标准
- •hearing Problem
- •Uncontrolled Epilepsy
- •Autonomic crises
- •Medical unstable state
- •Pregnant or likely to be (interrogation data) or breastfeeding woman
- •Healthy participants :
- •Inclusion Criteria:
- •Subjects with normal hearing
- •Absence of neurological disorder
- •Subjects able to understand the experimental instructions
- •Exclusion Criteria:
- •Hearing problems and / or hearing loss higher than 30 decibels Hearing Level (dB HL) at a frequency band from 250 to 8000 Hz
- •Neurological disorders
- •Pregnant or likely to be (interrogation data) or breastfeeding woman
研究组 & 干预措施
patients with disorders of consciousness
3 minutes stimulation with music,name,and noise separately,each are separated with a 5 minutes washout period.
干预措施: music,name,and noise sound (Device)
healthy control group
3 minutes stimulation with music,name,and noise separately,each are separated with a 5 minutes washout period.
干预措施: music,name,and noise sound (Device)
结局指标
主要结局
Glasgow Outcome Scale (GOS)
时间窗: In one year
A GOS value of \<3 was considered as a bad recovery, while a GOS value of ≥3 was considered as a good recovery
次要结局
- quantitative electroencephalography(30 minutes before the auditory stimualtion and 30 minutes after each stimulation)