跳至主要内容
临床试验/NCT04798456
NCT04798456Unknown不适用

A Multimodal Approach to Personalized Tracking of Evolving State-Of-Consciousness in Brain- Injured Patients

Paris Brain Institute (ICM)4 个研究点 分布在 4 个国家目标入组 150 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
4
主要终点
Caregivers: use of questionnaires to asses change in factors that impact well-being and treatment decisions of informal caregivers/family members confronted with multimodal technology-based tests for DoC patients

研究概览

简要总结

Improved treatment of severe brain injuries has resulted in increased survival rates. While some of these patients regain consciousness after a transient state of coma, others may develop a disorder of consciousness (DoC). Diagnosis of DoC currently relies on standardized behavioral assessment. The importance of accuracy in such diagnosis cannot be overstated, as it guides critical decisions on treatment (including pain management), and could underlie end-of-life decisions. Despite this importance, current behavioral diagnosis often fails, if because of the major sensory and motor deficits associated with DoC, or because of the heterogeneous etiology and pathophysiology associated with the condition. Finally, the need for accurate diagnosis and prognosis transcends the needs of the patients alone: caregiving of these patients is very stressful, principally for the large uncertainty associated with them. Thus, more accurate diagnosis and prognosis provide major relief for caregivers, and paradoxically, even if the news is not "good". For all these reasons it is critical to developing personalized diagnosis and prognosis prediction tools that permit a stratified analysis at the single-patient level. The PerBrain Project will benefit from the multidisciplinary partners' expertise, and the unique opportunity to perform longitudinal assessments in four clinical sites through both established and novel electrophysiological, neuroimaging, and physiological techniques. Based on the collected data, the investigators will develop a multimodal personalized diagnostic tool for DoC patients using state-of-the-art computational tools, such as machine learning, in order to better determine the current state (diagnosis) and future outcome (prognosis). The overall aim of this project will provide for a better understanding of the pathophysiological mechanisms in DoC, which will, in turn, allow personalized rehabilitation strategies, and improved single-patient predictions of state and prognosis.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Caregivers: use of questionnaires to asses change in factors that impact well-being and treatment decisions of informal caregivers/family members confronted with multimodal technology-based tests for DoC patients

时间窗: Changes from C0: before T1 (1-2 Months from injury); C1: between T1(1-2 Months from injury) and T2 (4-7 Months from injury); C2: between T2 (4-7 Months from injury) and T3 (9-12 Months from injury); C3: after T3 (9-12 Months from injury)

Semi-structured qualitative Interview based on a thematic grid for brochure development

Patients: Implementation of a hierarchical multi-modal personalized procedure to diagnose and track the change of the state of consciousness in brain-injured patients

时间窗: Changes from T1: 1-2 Months from injury; T2: 4-7 Months from injury; T3: 9-12 months from injury

Structural MRI and functional MRI (without contrast agent)

次要结局

  • Caregivers: develop a brochure/guide to be applied in clinical practice for the effective communication of technology-based results(12 months)

研究者

发起方
Paris Brain Institute (ICM)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacobo Sitt

Research Director, INSERM

Paris Brain Institute (ICM)

研究点 (4)

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