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临床试验/NCT06960811
NCT06960811已完成不适用

Study of Association Between Ictal Affective Symptoms, Ictal Consciousness Level and the Presence of Comorbid Epileptic Psychoses

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2025年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
117
试验地点
1
主要终点
Ictal emotions

研究概览

简要总结

Background :

Psychiatric comorbidities are common in epilepsy, affecting 50 to 70% of patients, especially when the epilepsy is focal and drug-resistant. Among these comorbidities, psychotic disorders (involving hallucinations and delusions) affect 8% of patients - that is, eight times more frequently than in the general population. Currently, the links between epilepsy and psychotic disorders are poorly understood and often overlooked by physicians, which impacts the mental health care of patients with epilepsy and leads to underdiagnosis.

The aim of this research is to determine whether there are differences in epileptic symptoms between patients with a psychotic comorbidity and those without.

Study design :

The main objective of this research is to better understand whether certain emotional epileptic symptoms are associated with a higher risk of developing psychotic symptoms.

The secondary objectives of this study are to investigate whether the level of consciousness during seizures is associated with a higher risk of developing psychotic symptoms.

To meet these objectives, the study will include patients who (1) have epilepsy, (2) were hospitalized in the video-EEG unit of the Neurology Department at Central Hospital for seizure recording, and (3) underwent a psychiatric evaluation in the context of epilepsy between January 1, 2016, and April 1, 2025.

The study will take place at the University Hospital Center (CHRU) of Nancy, in the Neurology Department, within the video-EEG unit led by Professor Louis Maillard. The research will involve comparing epileptic symptoms between the group of patients without psychosis and the group of patients with psychosis.

Data collection will cover the five days of video-EEG hospitalization, along with information from the psychiatric evaluation, for a total duration of approximately one week per year.

Information for participants:

As part of the routine medical care, data is collected in medical records to ensure appropriate follow-up. For the purposes of this research, data from the medical record will be collected.

No identifying information (such as name, initials, full date of birth, address, or social security number) will be collected.

No additional visits or examinations will be required. Patients will not be contacted or asked to provide any new information.

研究设计

研究类型
Observational
观察模型
Case Control
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
否

入选标准

  • •Patients with a confirmed diagnosis of epilepsy
  • •Patients hospitalized for at least 5 days for a video-EEG recording
  • •Patients with a psychiatric evaluation, conducted between 01/01/2016 and 04/01/
  • •Adult patients able to express their opposition to the use of their data.

排除标准

  • •Absence of seizure recorded during the video-EEG

结局指标

主要结局

Ictal emotions

时间窗: From april 2025 to may 2025

Clinician-assessment of ictal affective symptomatology (facial, verbal, and motor expression), based on a the visualization of an usual seizure recorded in video-EEG.

次要结局

  • Ictal consciousness(From april 2025 to may 2025)
  • Ictal dysautonomy(From april 2025 to may 2025)
  • Type of aura(From april 2025 to may 2025)

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

TARRADA Alexis

M.D.

Central Hospital, Nancy, France

研究点 (1)

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