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临床试验/NCT07527949
NCT07527949尚未招募不适用

PASTRAMI : Patient-specific Statistics for Microstructure-augmented Connectomics

Rennes University Hospital2 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
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
2
主要终点
Measures of brain microstructure

研究概览

简要总结

Traumatic brain injury (TBI) represent a major public health issue, accounting for approximately 1.5 million hospital admissions annually across the European Union and 160,000 cases in France. They are a significant cause of mortality and disability, with serious consequences for patients and their families. Predicting functional outcomes remains complex due to the heterogeneity of brain injuries, whether primary or secondary, as well as the mechanisms involved, particularly neuroinflammation. This difficulty is particularly pronounced for moderate to severe TBI, for which current predictive tools are still limited.

The PASTRAMI project proposes to utilise diffusion magnetic resonance imaging (MRI) to identify biomarkers associated with axonal lesions in the white matter. This technique enables the analysis of brain microstructure and the reconstruction of neural connections (connectome), thereby offering innovative prospects for improving the prediction of functional recovery.

This is a prospective, multicentre, interventional study involving 100 patients aged between 18 and 60 years with moderate to severe traumatic brain injury. The primary objective is to assess the prognostic value of brain microstructural measures at baseline, by correlating them with the GOSE functional score at 1 year. Secondary objectives include the analysis of mortality, functional outcome, quality of life, and early physiological factors influencing progression.

Patients will undergo a standard MRI scan supplemented with additional sequences for prognostic purposes, without any change to their therapeutic management. The associated risks are minimal and relate primarily to the MRI scan. No immediate individual benefit is expected, but the results could improve our understanding of brain lesions and optimise future management.

The total duration of the study is 48 months. The expected outcomes include better characterisation of lesions and improved predictive tools, contributing to more appropriate clinical decisions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 to 60
  • Admitted for moderate to severe non-penetrating head injury (with a Glasgow Coma Scale score ≤ 12)
  • On mechanical ventilation and under continuous sedation
  • Enrolled in a social security program
  • Whose family has been informed and has signed a voluntary, informed, written consent form

排除标准

  • History of head trauma, stroke, or neurodegenerative diseases
  • A decision to limit active treatment has already been made
  • Quadriplegia
  • Contraindications to MRI
  • Protected individuals (adults under legal protection [judicial protection, guardianship, conservatorship], individuals deprived of liberty, pregnant women [self-reported], breastfeeding women, and minors).

研究组 & 干预措施

Additional imaging studies for prognostic purposes

Experimental

干预措施: Measures of brain microstructure (Other)

结局指标

主要结局

Measures of brain microstructure

时间窗: baseline

Correlation between the GOSE score at 1 year and measures of brain microstructure at baseline

GOSE score

时间窗: 1 year

Correlation between the GOSE score at 1 year and measures of brain microstructure at baseline

GOSE score (Glasgow Outcome Scale Extended) [between 1 and 8 (higher score mean a better outcome)]

时间窗: 1 year

Correlation between the GOSE score at 1 year and measures of brain microstructure at baseline

次要结局

未报告次要终点

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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