Development of a New Diagnosis and Intervention Method for Developmental Disorders (DIDD)
Recruitment status was Recruiting
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.
|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|
- 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.
- 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.
|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)|
Behavioral: social skills training
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166152
|Ashiya University Graduate School of Clinical Education||Recruiting|
|Ashiya, Hyogo, Japan, 659-8511|
|Contact: Kunio Yui, MD 81-797-23-0661 firstname.lastname@example.org|
|Contact: Shun Nakamura, PhD 81-423-88-7770 email@example.com|
|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|