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临床试验/NCT03615703
NCT03615703已完成不适用

Functional Neuroimaging Study to Validate the Point Subtraction Aggression Paradigm (PSAP) Task in Typically Developing Children (TDC) Aged 8-12 Years

Supernus Pharmaceuticals, Inc.1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年8月10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
17
试验地点
1
主要终点
Brain Imaging in typically developing healthy children during the PSAP aggression Task

研究概览

简要总结

The purpose of this non-interventional study is to optimize the point subtraction aggression paradigms (PSAP) task in typically developing children (TDC).

详细描述

The PSAP is a behavioral aggression test used to evaluate behavioral response related to impulsive aggression. The task will be combined with functional MRI to establish a reliable BOLD signal during testing in developing healthy subjects (8-12 years old) and, to determine the feasibility to perform the task.

Additionally, the levels of neurotransmitters Glutamate and GABA will be measured using magnetic resonance spectroscopy (MRS).

研究设计

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

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy male or female subjects, aged 8-12 years (inclusive) at the time of screening.

排除标准

  • Current history of developmental, psychiatric, or neurologic disorder, including seizures (except for uncomplicated brief febrile seizures), tumor, severe head injury/traumatic brain injury, stroke, lesion, or disease.
  • Known or suspected intelligence quotient (IQ) <70, diagnosis of mental retardation or cerebral palsy or speech/language disorder and history of implanted brain stimulator, vagal nerve stimulator, ventriculoperitoneal shunt, cardiac pacemaker, orthodontic braces, or implanted medication port.
  • Visual and hearing (≥25 dB) impairment.
  • Pre-existing medical or psychological conditions that preclude being in the MRI scanner (e.g., claustrophobia, morbid obesity, or marked anxiety about the procedure).

结局指标

主要结局

Brain Imaging in typically developing healthy children during the PSAP aggression Task

时间窗: The study consist of one visit (total time-2 hrs.).

The study has only one visit (approximately 2 hours). During the task each participant competes against a fictitious opponent (a computer in reality) to earn points. The participant will play a computer game in which they can steal points (simulating an aggressive behavior) or have points stolen by the opponent. 10 healthy subjects will be recruited for the study. To make the participant feel comfortable in the MRI, eligible subjects will spend time first to habituate to the scanner and then practice the task. The complete MRI will last one and half hour (at most). Functional imaging data (neural activation) will be collected during the behavioral aggression task, while playing the game. In addition, imaging data will be collected at resting state to understand the connectivity between regions of interest before and after the aggression task.

次要结局

  • GABA and Glutamate Levels(The study consist of one visit (total time-2 hrs.).)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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