跳至主要内容
临床试验/NCT04425798
NCT04425798Unknown不适用

Connectivity Alterations of Brain Network in LGG Patients After Levetiracetam Application at Short Term

Beijing Neurosurgical Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年5月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
The connectivity alterations of brain networks in patients with and without levetiracetam application

研究概览

简要总结

This study aimed to analyze the connectivity alterations in brain networks of LGG patients with epilepsy who take levetiracetam at short-term preoperatively.

详细描述

Glioma-related epilepsy (GRE) is a very common symptom in patients with diffuse gliomas. Approximately 60% of patients with low-grade gliomas (LGGs) and 40-64% of patients with high-grade gliomas presented with GRE at the onset. Although beneficial for the control of GRE, the overall therapeutic effect was unsatisfied and over 20% of patients still suffered from seizures.

GRE was found to be associated with brain network and functional connectivity. And it has been reported that temporal lobe seizures could induce functional connectivity and decreased network efficiency of brain networks. However, the alterations in functional networks induced by GRE were still unclear. And LGG patients with GRE usually take levetiracetam (LEV) preoperatively, which could effectively reduce abnormal spike activity and further cause connectivity alterations. This makes it more complex to reveal the connectivity alterations of brain networks in LGG patients with GRE.

This study aimed to collect the resting-state functional MRIs of 30 LGG patients who presented with GRE at the onset. Through further applied graph theory analysis, investigators tend to reveal the connectivity alterations of brain networks caused by levetiracetam. The findings of this study will provide a theoretical basis for further study of connectivity alterations of brain networks in patients with GRE.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years;
  • Histopathological diagnosis with LGG according to the 2016 World Health Organization (WHO) criteria;
  • Participants received more than 6 years of school education;
  • Presence of GRE, take levetiracetam less than 1 month; or do not take any medicine and receive any treatment;
  • No history of biopsy, radiotherapy, or chemotherapy.

排除标准

  • Contraindications for MRI;
  • Head motion greater than 3 mm in translation or 3° in rotation;

结局指标

主要结局

The connectivity alterations of brain networks in patients with and without levetiracetam application

时间窗: through study completion, an average of 2 years

Graph theory analysis is used to delineate topological networks with resting-state functional MRIs and investigated the characteristics of functional networks. Global and nodal topological properties of brain networks are calculated in the two groups of patients. The difference of topological properties of brain networks between patients with and without levetiracetam application are analyzed using t-test or chi-square test according to the type of data.

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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