Developmental Disabilities Clinical Trial
Official title:
Development of a New Diagnosis and Intervention Method for Developmental Disorders
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
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