Development of a New Diagnosis and Intervention Method for Developmental Disorders
DIDD
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2010
CompletedFirst Posted
Study publicly available on registry
July 20, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedJuly 21, 2011
July 1, 2010
1.3 years
July 19, 2010
July 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
thermogram of head
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
Secondary Outcomes (1)
view direction
at least 8 weeks after intervention
Interventions
meeting once a week or biweekly to play together using toys, games, and physical exercises.
Eligibility Criteria
You may qualify if:
- Developmental disorders
You may not qualify if:
- Mental retardation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tokyo University of Agriculture and Technologylead
- Ashiya Universitycollaborator
- Saitama Medical Universitycollaborator
Study Sites (1)
Ashiya University Graduate School of Clinical Education
Ashiya, Hyōgo, 659-8511, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kunio Yui, MD, PhD
Ashiya University
- PRINCIPAL INVESTIGATOR
Hideo Yamauchi, MD, PhD
Saitama Medical University
- PRINCIPAL INVESTIGATOR
Mamiko Koshiba, PhD
Tokyo University of Agriculture and Techinology
- PRINCIPAL INVESTIGATOR
Shun Nakamura, PhD
Tokyo University of Agriculture and Techinology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 19, 2010
First Posted
July 20, 2010
Study Start
August 1, 2010
Primary Completion
November 1, 2011
Study Completion
March 1, 2013
Last Updated
July 21, 2011
Record last verified: 2010-07