Electrophysiological Evaluation of Voluntary Attention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 22
- 主要终点
- Research of statistical differences between sensory evoked potentials in attentional oriented condition and distracted condition
研究概览
简要总结
Aim : To assess the ability of healthy subjects and patients with a severe motor disability to voluntary control their attention
Material and Methods:
Population: healthy subjects, patients with brain injury Electroencephalographic study to research attentional modulation during different kind of stimulation (visual, auditory, tactile)
Sudy 1: passive recording.
Study 2: active recording (instruction of attentional control given to the subject).
Study 3: active recording with a feedback obtained after a processing of the brain activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Inclusion criteria for patients :
- •Adults, man or woman, left or right-handed, from 18 years old to 80 years-old ;
- •Diagnosis :
- •Locked-in syndrome :
- •< Brainstem injury, without any evolution for at least 3 week, etiology : vascular, traumatic < Amyotrophic Lateral Sclerosis < Following damage to the central or peripheral nervous system
- •Or Minimal conscious state or Unresponsive Wakefulness Syndrome consecutive to a severe acquired brain injury for at least one month
- •Or with a severe brain injury, since birth or acquired, for at least one month
- •Or with Guillain-Barré syndrome
- •Subjects affiliated to social security;
- •Signature of consent form by the patient or by a relative (family member or "the trusted person") if obtaining a consent is impossible
- •Inclusion criteria of Healthy subjects
- •Adults, man or woman, left or right-handed, from 18 years old to 80 years-old ;
- •Without known auditory impairment
- •Subjects able to understand the experimental instructions
- •Subjects affiliated to social security;
- •Signature of consent form
- •Exclusion criteria of patients and healthy subjects
- •Medical history : psychiatric disorders (except if due to brain injury), neurologic disorders (except if due to brain injury)
- •For healthy subjects : history of brain injury
- •Pregnant women or breastfeeding women
- •Person under legal protection
- •Medico-legal conflicts
- •Absence of consent by the subject or the patient or his/her representant
排除标准
- 未提供
研究组 & 干预措施
Electrophysiological assessment of Healthy subjects
Experiences 1, 2 and 3 with healthy subjects
干预措施: electrophysiological evaluation (Other)
Electrophysiological assessment of patients
Experiences 1, 2 and 3 with patients
干预措施: electrophysiological evaluation of patients (Other)
结局指标
主要结局
Research of statistical differences between sensory evoked potentials in attentional oriented condition and distracted condition
时间窗: through study completion, an average of 3 years
stastical analysis allowing to compare evoked responses during different stimulation condition (attentionnaly oriented versus attentionnally distracted versus passive condition = no instruction to the subject). These comparisons are made either for one single subject and at the group level. Analysis mainly concerns the differences in amplitude variation between the differents evoked potentials on several electrods of interest. These can vary between patients because of the different topographies of lesions and because of the different adaptative strategies. The statiscal difference will be assessed by a randomization test (also called "permutation test") wich allow to assess how high is the risk that the observed difference between the evoked potential (amplitude, variance) is due to chance or not
次要结局
- Online and offline accuracy(through study completion, an average of 3 years.)
- Clinical scale score ("Evaluation de la Communication des patients en Eveil de Coma" (ECEC) scale)(an average of 3 years (At the group level))