Characterization and Pathophysiology of Frustration in Pediatric Irritability
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- prediction of irritability ratings by global efficiency
研究概览
简要总结
Background:
Irritability is an elevated proneness to anger. Children with irritability have difficulty tolerating frustration. They get angry and have temper outbursts more easily than their others their age. Irritability is a symptom of DMDD and ADHD. (DMDD is disruptive mood dysregulation disorder. ADHD is attention deficit/hyperactivity disorder.) Yet the reasons why some children get irritated easily are not well understood.
Objective:
To use brain imaging methods to study responses to frustration in youth.
Eligibility:
Youth aged 8 to 17 years with severe irritability (including those diagnosed with DMDD) and/or ADHD. Healthy volunteers are also needed. All participants are already enrolled in studies 02-M-0021 or 01-M-0192.
Design:
Participants will visit the clinic 3 times. The second and third visits will be 3 to 4 weeks apart.
The first visit will be an enrollment visit. They will receive training on the tasks they will do during the study. Participants and their parents will take surveys. They will answer questions about their moods and feelings.
Participants will train for an MRI scan. They will lie in a mock scanner tube and hear the noises an MRI makes.
On the second and third visits, participants will have real MRI scans. They will play a computer game or watch a movie during each scan. The scans will last about 1 hour.
The week after each scan, participants will wear a device on their wrist to measure their heart rate and activity level. Participants and their parent will use a smartphone to answer questions about how they are feeling and acting. Participants who do not have smartphones will be given one to use during the study.
详细描述
Study Description:
Participants in this study will be drawn from those enrolled in Protocol 02-M-0021 or 01-M-0192. This protocol uses detailed clinical phenotyping and a frustration induction task, coupled with pre- and post-frustration resting state scans, to study brain mechanisms mediating severe irritability in youth. The primary objective is to identify brain networks contributing to reconfiguration during and after frustration, and to test the ability of brain network metrics obtained using a frustration induction task to predict irritability. The secondary objective is to test whether these predictions are strengthened by the addition of structural connectivity measures and deeper clinical phenotyping.
Objectives:
Primary Objective:
To use multi-modal functional magnetic resonance imaging (fMRI), including a frustration induction task, coupled with resting state functional connectivity (rsFC) pre- and post-frustration, to elucidate neural mechanisms mediating frustration and how aberrant responses to frustration contribute to severe irritability in youth. Specifically, we will identify brain networks contributing to reconfiguration during and after frustration and test the ability of brain network metrics to predict irritability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
prediction of irritability ratings by global efficiency
时间窗: one week after each of two scanning sessions, when ecological momentary assessment ratings are completed. The two scanning sessions will be 2-5 weeks apart.
global efficiency of brain modules in resting state after frustration will be used to predict irritability ratings obtained throughout the one week after each of two scanning sessions
Variance of information (VIn) measures
时间窗: data are obtained throughout each of the two scanning sessions. The two scanning sessions will be 2-5 weeks apart.
VIn metric will be used to identify the brain modules making the largest contribution to network reconfiguration throughout frustration
次要结局
- Diffusion tensor imaging (DTI) metrics(during first scanning session)
- ecological momentary assessment (EMA) measures(for one week after each of the two scanning sessions)