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临床试验/NCT07786298
NCT07786298尚未招募不适用

Validation of New Consciousness Indicators in Conscious Participants

University of Liege1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Additional signs of consciousness scale

研究概览

简要总结

The assessment of the diagnosis and prognosis of patients with disorders of consciousness (DoC) represents a major clinical and ethical challenge, as it may influence therapeutic decision-making. Despite the use of standardized assessment tools such as the Coma Recovery Scale-Revised (CRS-R), diagnostic errors persist. In order to improve the identification of residual conscious activity, several research studies have focused on identifying and validating new clinical indicators of consciousness.

In addition to the items already included in the CRS-R to characterize a minimally conscious state, some behavioral manifestations that are not yet included in current assessment scales are being investigated for their diagnostic potential. Mat et al. (2022) proposed several behavioral indicators, including leg crossing, auditory localization, habituation to the auditory startle reflex, resistance to eye opening, spontaneous blink rate, certain motor behaviors, facial expressions in response to nociceptive stimulation, swallowing or oral intake, and responses to olfactory stimuli. To these indicators, we added other potentially relevant behavioral manifestations, including responses to tickling, anticipation of painful stimulation, and responses to pleasant touch.

These different items were grouped into an Additional Signs of Consciousness (ASC) Scale. This scale aims to investigate whether these behavioral manifestations may constitute reliable new indicators of consciousness and contribute to improving the diagnostic and prognostic assessment of patients with DoC.

To date, this scale has primarily been used in post-coma patients with DoC. However, it is essential to assess the validity of these indicators in healthy, fully conscious participants. Indeed, the relevance of these signs as indicators of residual consciousness in post-coma patients can only be properly interpreted if they are also observable in conscious individuals. Therefore, the aim of this study is to validate these new indicators of consciousness in conscious participants.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult, French-speaking individuals with no neurological and/or psychiatric disorders or history thereof, and no uncorrected sensorimotor deficits.

排除标准

  • Minors, non-French-speaking individuals, individuals with neurological and/or psychiatric disorders or a history thereof, and individuals with uncorrected sensorimotor deficits.

结局指标

主要结局

Additional signs of consciousness scale

时间窗: single time point

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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