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临床试验/NCT04727931
NCT04727931招募中不适用

Prevalence of Cognitive Disorders in Newly Diagnosed Epilepsy

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年2月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
The percentage of impaired cognitive function at the time of diagnosis in patients and healthy subjects.

研究概览

简要总结

A prospective prevalence study recorded that up to 50% of adult patients with newly diagnosed epilepsy had at least one cognitive impairment before initiation of antiepileptic drug (AED). Multiple factors exist and interact in the same patient. Cognitive impairments may affect psychiatric (loss of self-esteem, anxiety, depression) and social status (e.g., vocational aptitude, educational). These factors in turn influence cognitive abilities in a triangular and bidirectional relationship. In addition, the type of epilepsy, development in childhood or cerebral ageing, antiepileptic treatments (AED, surgery) and etiology also have an impact on cognitive performances. The burden of these factors differs from patient to another and must be determined individually. Longitudinal follow-up seems to be crucial because it will allow us to highlight the change in the cognitive profile of newly diagnosed patients over time.

The main objective is to compare the prevalence of cognitive impairment in patients with newly diagnosed epilepsy prior to the initiation of AED with healthy subjects matched on age, sex, manual laterality and socio-educational level. But also to compare the longitudinal evolution of the cognitive profile of patients with healthy controls (0 to 10 years) to determine, among the age of onset seizures, their etiology, the syndrome, the sex, the socio-educational level and the cognitive reserve, which one are related to the severity of cognitive disorders.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
16 Years 至 —(Child, 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

The percentage of impaired cognitive function at the time of diagnosis in patients and healthy subjects.

时间窗: Baseline (up to 2 weeks after a diagnosis of epilepsy for a duration of 1h30)

Neuropsychological assessment: * BVMT-R * RL/RI-16 * Digit span forward and backward (WASI-IV) * Stroop test * Verbal fluency * TMT * Code * Oral naming Questionnaires: * NDDI-E * GAD-7 * Beck inventory * STAI * CRI-q

次要结局

  • Proportion of impaired cognitive functions according to the cognitive domain assessed(Baseline, 6 months, 12 months, 3 years, 6 years and 10 years after the baseline (for a duration of 1h30 at each assessment))

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maillard Louis

Professor

Central Hospital, Nancy, France

研究点 (1)

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