Clinical trial NCT01166152: Development of a New Diagnosis and Intervention Method for Developmental Disorders
Official title: Development of a New Diagnosis and Intervention Method for Developmental Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Developmental Disabilities
Keywords: autistic spectrum disorders
developmental disorders
Lead sponsor: Tokyo University of Agriculture and Technology
Sponsor class: OTHER
Collaborators: name: Ashiya University
name: Saitama Medical University
First posted: 2010-07-20
Enrollment: 20
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* Developmental disorders

Exclusion Criteria:

* Mental retardation

Primary outcomes:
measure: thermogram of head
timeFrame: at least 8 weeks after intervention
Secondary outcomes:
measure: view direction
timeFrame: at least 8 weeks after intervention
Other outcomes:
Locations:
city: Ashiya
country: Japan
facility: Ashiya University Graduate School of Clinical Education
state: Hyogo
Study officials:
affiliation: Ashiya University
name: Kunio Yui, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saitama Medical University
name: Hideo Yamauchi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tokyo University of Agriculture and Techinology
name: Mamiko Koshiba, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tokyo University of Agriculture and Techinology
name: Shun Nakamura, PhD
role: PRINCIPAL_INVESTIGATOR
References: