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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Tokyo University of Agriculture and Technology.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Ashiya University
Saitama Medical University
Information provided by:
Tokyo University of Agriculture and Technology
ClinicalTrials.gov Identifier:
NCT01166152
First received: July 19, 2010
Last updated: July 20, 2011
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention
Developmental Disabilities
 Behavioral: social skills training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Development of a New Diagnosis and Intervention Method for Developmental Disorders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tokyo University of Agriculture and Technology:

Primary Outcome Measures:
  • thermogram of head [ Time Frame: at least 8 weeks after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: at least 8 weeks after intervention ] [ Designated as safety issue: No ]
    The subject view direction will be monitored using the video camera (Sony) during clinical interview.


Estimated Enrollment: 20
Study Start Date: August 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: social skills training
    meeting once a week or biweekly to play together using toys, games, and physical exercises.
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.

  Eligibility

Ages Eligible for Study:   up to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Developmental disorders

Exclusion Criteria:

  • Mental retardation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166152

Locations
Japan
Ashiya University Graduate School of Clinical Education Recruiting
Ashiya, Hyogo, Japan, 659-8511
Contact: Kunio Yui, MD     81-797-23-0661     yui16@bell.ocn.ne.jp    
Contact: Shun Nakamura, PhD     81-423-88-7770     nakashn@cc.tuat.ac.jp    
Sponsors and Collaborators
Tokyo University of Agriculture and Technology
Ashiya University
Saitama Medical University
Investigators
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
  More Information

No publications provided

Responsible Party: Shun Nakamura/Professor, Tokyo University of Agriculture and Technology
ClinicalTrials.gov Identifier: NCT01166152     History of Changes
Other Study ID Numbers: TokyoUAT_21_11
Study First Received: July 19, 2010
Last Updated: July 20, 2011
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology
Japan: Ministry of Health, Labor and Welfare

Keywords provided by Tokyo University of Agriculture and Technology:
autistic spectrum disorders
developmental disorders

Additional relevant MeSH terms:
Developmental Disabilities
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013