Development of a New Diagnosis and Intervention Method for Developmental Disorders (DIDD)
Primary Purpose
Developmental Disabilities
Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
social skills training
Sponsored by
About this trial
This is an interventional diagnostic trial for Developmental Disabilities focused on measuring autistic spectrum disorders, developmental disorders
Eligibility Criteria
Inclusion Criteria:
- Developmental disorders
Exclusion Criteria:
- Mental retardation
Sites / Locations
- Ashiya University Graduate School of Clinical EducationRecruiting
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
view direction
The subject view direction will be monitored using the video camera (Sony) during clinical interview.
Full Information
NCT ID
NCT01166152
First Posted
July 19, 2010
Last Updated
July 20, 2011
Sponsor
Tokyo University of Agriculture and Technology
Collaborators
Ashiya University, Saitama Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01166152
Brief Title
Development of a New Diagnosis and Intervention Method for Developmental Disorders
Acronym
DIDD
Official Title
Development of a New Diagnosis and Intervention Method for Developmental Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
March 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tokyo University of Agriculture and Technology
Collaborators
Ashiya University, Saitama Medical University
4. Oversight
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Disabilities
Keywords
autistic spectrum disorders, developmental disorders
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
social skills training
Intervention Description
meeting once a week or biweekly to play together using toys, games, and physical exercises.
Primary Outcome Measure Information:
Title
thermogram of head
Description
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.
Time Frame
at least 8 weeks after intervention
Secondary Outcome Measure Information:
Title
view direction
Description
The subject view direction will be monitored using the video camera (Sony) during clinical interview.
Time Frame
at least 8 weeks after intervention
10. Eligibility
Sex
All
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Developmental disorders
Exclusion Criteria:
Mental retardation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kunio Yui, MD, PhD
Organizational Affiliation
Ashiya University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hideo Yamauchi, MD, PhD
Organizational Affiliation
Saitama Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mamiko Koshiba, PhD
Organizational Affiliation
Tokyo University of Agriculture and Techinology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shun Nakamura, PhD
Organizational Affiliation
Tokyo University of Agriculture and Techinology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ashiya University Graduate School of Clinical Education
City
Ashiya
State/Province
Hyogo
ZIP/Postal Code
659-8511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kunio Yui, MD
Phone
81-797-23-0661
Email
yui16@bell.ocn.ne.jp
First Name & Middle Initial & Last Name & Degree
Shun Nakamura, PhD
Phone
81-423-88-7770
Email
nakashn@cc.tuat.ac.jp
12. IPD Sharing Statement
Learn more about this trial
Development of a New Diagnosis and Intervention Method for Developmental Disorders
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