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临床试验/NCT03679403
NCT03679403已完成不适用

A Longitudinal Follow-up Study of Neuroimage and Neuropsychological Endophenotype Study on ADHD

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 293 人开始时间: 2017年8月1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
293
试验地点
1
主要终点
Functional connectivity: Single-echo (SE)

研究概览

简要总结

Attention deficit/hyperactivity disorder (ADHD) is a common (3-10%), early-onset, clinically and genetically heterogeneous neuropsychiatric disorder with lifelong neuropsychological deficits. Despite many imaging studies on ADHD across countries, only few longitudinal studies investigated the developmental changes of structural and functional brain connectivity and some imaging studies using unaffected sibling design in western countries. There is no published data regarding developmental changes in brain functions assessed by neuropsychology/physiology/image in Asia and Taiwan as well. The ultimate goals of this 3-year project are to identify which neuropsychological, functional and structural connectivity, and neurophysiological variables can be effective endophenotypes (biomarkers) for ADHD based on this follow-up unaffected sibling study design. Due to the limitation of diffusion tensor image (DTI), original analysis of diffusion spectrum image (DSI), and single-echo resting-state functional MRI (SE rsfMRI), the investigators will adopt Mean Apparent Propagator (MAP)-MRI, tract-based autonomic analysis (TBAA) and multi-echo (ME) rsfMRI in this project. With the accomplishment of the following study goals, this study will be the first longitudinal follow-up neuroimaging/physiological endophenotypes study on ADHD using advanced imaging techniques and comprehensive clinical and neurocognitive data.

详细描述

Primary Aim:

  1. To examine the developmental changes and stability of neuropsychological functions (NFs, assessed by CPT and CANTAB) and structural (morphometric, cortical thickness, gyrification, fiber tract integrity) and functional connectivity (assessed by SE rsfMRI, counting-Stroop fMRI) from childhood to late adolescence and young adulthood;

Secondary Aims: 2. To validate a wide range of neuropsychological functions (assessed by CPT, CANTAB, CNB), structural and functional connectivity in the frontostriatal (FS), frontoparietal (FP) and other circuitries, and neurophysiological functions (assessed by event-related potential [ERP]: MMN, Gamma ARRS) as effective imaging endophenotypes by demonstrating the intermediate position of unaffected siblings between ADHD probands, and age-, sex-, and handedness-matched neurotypicals at Time 1 and Follow-up; 3. To identify the Time 1 predictors (behavioral symptoms, NFs, and imaging data) for Follow-up neuroimaging data (Morphometric, DSI, rfMRI, task-fMRI, MMN, Gamma ARRS); and 4. To correlate all kinds of neurocognitive data and clinical symptoms profiles stratifying by the presence of ADHD, proband-unaffected sibling dyads, and two time points.

Hypothesis The investigators anticipated despite increasing thinning of cortical thickness, microstructural integrity of several targets fiber tracts, and brain activity of target brain regions and improving neuropsychiatric performance from childhood to late adolescence/young adulthood in neurotypicals and probably in ADHD with lower developmental changes slope in ADHD. These changes of unaffected siblings are in the intermediate position between the ADHD probands and neurotypicals. For the endophenotype part, the investigators anticipate that ADHD probands may have a higher level of altered microstructural integrity and decreased brain activity of the FS, FP, other hypothesized fiber tracts/brain networks, deficits in MMN and Gamma, and impaired a wide-ranging NFs than neurotypicals. These differences in the unaffected siblings would be in the intermediate position between ADHD probands and neurotypicals.

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
15 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects who received the same MRI and neuropsychological assessments during 2010.8-2015.7(NCT00916851, NCT01682915).

排除标准

  • Subjects will be excluded from the study if they have (1) neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital metabolic disorder, brain tumor, history of severe head trauma, or history of craniotomy; and (2) visual or hearing impairments, or motor disability which may influence MRI assessment.

结局指标

主要结局

Functional connectivity: Single-echo (SE)

时间窗: 1 day

SE will be used to evaluate functional connectivity.

Neuropsychological functions: Continuous Performance Test(CPT)

时间窗: 1 day

The 4 dimensions of CCPT: focused attention, hyperactivity/impulsivity, sustained attention, and vigilance.

Structural neuroimaging: Diffusing spectrum imaging (DSI)

时间窗: 1 day

Using a pulsed-gradient spin-echo diffusion EPI(echo planar imaging) sequence with a twice-refocused balanced echo to acquire diffusion-weighted images

Multi-echo (ME) Resting-state fMRI (rsfMRI)

时间窗: 1 day

rsfMRI will be used to evaluate functional connectivity.

Neuropsychological functions: Cambridge Neuropsychological Test Automated Batteries(CANTAB)

时间窗: 1 day

The 4 main cognitive components of CANTAB: Visual Memory, Attention, Working and Planning Memory (Executive Functions), and Decision Making.

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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