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临床试验/NCT03097809
NCT03097809已完成不适用

SEEG Investigation of Mood Dysregulation in People With Epilepsy

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2017年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
Resting state cortico-limbic brain connectivity

研究概览

简要总结

Using the novel analysis of stereo-electroencephalography (SEEG) recordings, this proposal will investigate the activity and connectivity of mood regulation circuits in subjects with suspected epileptic focus who have undergone SEEG electrode implantation for monitoring of seizure activity.

详细描述

It is well known that epilepsy is associated with mood dysregulation including symptoms of labile mood, impulse control problems, anxiety, depression and increase in incidence of suicide. However, until present the neurobiological basis of mood dysregulation in epilepsy has not been clear and has been mostly attributed to a psychological reaction to the illness. This has severely limited our understanding of the impairments in mood regulation that people with epilepsy often experience and has also limited the development of effective treatment for ameliorating psychosocial dysfunction in people with epilepsy. The identification of these circuits will not only increase our understanding of mood-regulation in epilepsy but also possibly provide biomarkers with which the effectiveness of new treatments can be investigated. Developing better diagnostic measures and treatments for mood dysregulation will be highly beneficial to the quality of life of subjects suffering from epilepsy.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Subjects will be a part of the epilepsy-monitoring unit for long-term SEEG recordings and analysis

排除标准

  • Subjects that experience surgical complications during the implant procedure will be excluded from the study

结局指标

主要结局

Resting state cortico-limbic brain connectivity

时间窗: 2 years

Resting state recordings will be collected from the cortical areas - prefrontal cortex, orbitofrontal cortex and anterior and posterior cingulate cortex as well as limbic areas - amygdala and hippocampus

Emotional Face Task and Emotional Go-No Go Task

时间窗: 2 years

To use face pictures depicting negative, positive and neutral emotions this task measures brain area activation abnormalities while responding and inhibiting responses to positive and negative emotions.

Maintaining and suppressing emotions

时间窗: 2 years

To use the International Affective Picture System, subjects will be asked to either maintain or suppress their emotions.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amit Anand, MD

MD

The Cleveland Clinic

研究点 (1)

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