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Development of a New Diagnosis and Intervention Method for Developmental Disorders (DIDD)

2011年7月20日更新者：Tokyo University of Agriculture and Technology

The purpose of this study is to develop a new diagnostic method for developmental disorders based on behavior recording during the interview of the subjects by medical staff as well anonymous persons. The behavior recording by video camera will be accompanied by non-invasive physiological recordings, including electroencephalogram (EEG), electrocardiogram (ECG), electromyogram (EMG), and body temperature using infrared (IR) thermograph. Thus, the physiologically relevant and the disorder correlated behavior parameters could be extracted and used as new diagnostic markers. If necessary, the medical staff may take blood sample from the subject before and after the interview. For the longitudinal study, the similar interview and the recording of the same subject will be planned to evaluate the effect of the medical and educational intervention. The investigators also examine the synergistic effect of the intervention and the administration of the supplement (e.g., vitamin D, arachidonic acid, coenzyme Q10 (CoQ-10)). The clinician may use Risperidone.

研究概览

地位

未知

条件

发育障碍

干预/治疗

行为的：social skills training

详细说明

Case 1:The investigators started the intervention and supplementation of arachidonic acid for 3 patients diagnosed as autistic spectrum disorders (ASD) from September 4, 2010 at Sawa hospital (Osaka, Japan). Another ASD patients (n=5) at Sawa hospital were treated by administration of Risperidone as medicinal drink from January 14, 2011. The supplementation as well as Risperidone administration followed double-blind placebo controlled cross-over protocol to access the effect of the treatment. These trials will continue until November 2011. Final outcome will be evaluated by clinical diagnosis and behavior parameters measurement as described under Brief Summary.

Case 2: The investigators started the intervention and supplementation of reduced form of CoQ10 for learning disability children (n=20) at small private cramming school (JIZAI-ken, Tokyo) from February 5, 2011. This trial will continue until October 2011. The effect of the intervention and supplementation will be evaluated by behavior parameter measurement as described above.

研究类型

介入性

注册 (预期的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

日本
- Hyogo
  - Ashiya、Hyogo、日本、659-8511
    - 招聘中
    - Ashiya University Graduate School of Clinical Education
    - 接触：
      
      Kunio Yui, MD
      
      电话号码：81-797-23-0661
      
      邮箱：yui16@bell.ocn.ne.jp
    - 接触：
      
      Shun Nakamura, PhD
      
      电话号码：81-423-88-7770
      
      邮箱：nakashn@cc.tuat.ac.jp

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 50年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Developmental disorders

Exclusion Criteria:

Mental retardation

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：诊断
分配：非随机化
介入模型：单组作业
屏蔽：单身的

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
thermogram of head 大体时间：at least 8 weeks after intervention	The themogram of head will be measured using IR camera (TVS-500EX, NEC Avio) during clinical interview to see the change of autonomic nervous system activity.	at least 8 weeks after intervention

次要结果测量

结果测量	措施说明	大体时间
view direction 大体时间：at least 8 weeks after intervention	The subject view direction will be monitored using the video camera (Sony) during clinical interview.	at least 8 weeks after intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Tokyo University of Agriculture and Technology

合作者

Saitama Medical University

Ashiya University

调查人员

首席研究员：Kunio Yui, MD, PhD、Ashiya University
首席研究员：Hideo Yamauchi, MD, PhD、Saitama Medical University
首席研究员：Mamiko Koshiba, PhD、Tokyo University of Agriculture and Techinology
首席研究员：Shun Nakamura, PhD、Tokyo University of Agriculture and Techinology

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年8月1日

初级完成 (预期的)

2011年11月1日

研究完成 (预期的)

2013年3月1日

研究注册日期

首次提交

2010年7月19日

首先提交符合 QC 标准的