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Development of a New Diagnosis and Intervention Method for Developmental Disorders

NCT01166152 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-07-21

No results posted yet for this study

Summary

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.

Conditions

  • Developmental Disabilities

Interventions

BEHAVIORAL

social skills training

meeting once a week or biweekly to play together using toys, games, and physical exercises.

Sponsors & Collaborators

  • Ashiya University

    collaborator OTHER

  • Saitama Medical University

    collaborator OTHER

  • Tokyo University of Agriculture and Technology

    lead OTHER

Principal Investigators

  • Kunio Yui, MD, PhD · Ashiya University

  • Hideo Yamauchi, MD, PhD · Saitama Medical University

  • Mamiko Koshiba, PhD · Tokyo University of Agriculture and Techinology

  • Shun Nakamura, PhD · Tokyo University of Agriculture and Techinology

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-11-30
Completion
2013-03-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01166152 on ClinicalTrials.gov