跳至主要内容
临床试验/NCT05802524
NCT05802524已完成不适用

Neurophysiological Approach for the Evaluation of Residual Cognitive Functions in Patients With Severe Alterations of Consciousness

IRCCS Centro Neurolesi "Bonino-Pulejo"1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年6月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Event-related evoked potentials(ERPs)

研究概览

简要总结

Identify potential markers of recovery through event-related potentials (ERPs) in the evolution of altered consciousness with potential ability to discriminate between different conditions of altered state of consciousness.

Identify potential markers with prognostic value, in order to identify personalized and specific intensive rehabilitation paths based on the outcome indexes obtained.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Glasgow Coma Scale (GCS) > 8;
  • Level of Cognitive Scale (LCF) = 1-3;
  • Signature of the consent from the family member and/or guardian.

排除标准

  • Failure to sign the consent of the family member and/or legal guardian;
  • Patients with cranial anatomical alterations that do not allow the correct assembly of the electrodes, caps, etc.;
  • Patients with absence of neurophysiological responses in visual evoked potentials (VEP) and with absence of peripheral waves (I-II wave) to acoustic potentials (PEA).

结局指标

主要结局

Event-related evoked potentials(ERPs)

时间窗: 24 months

Event-related evoked potentials(ERPs) are variations of the electric potential deriving from a visual, somesthetic or auditory stimulus.

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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