Development of a New Diagnosis and Intervention Method for Developmental Disorders

Developmental Disabilities Clinical Trial

— DIDD  

Official title:

Development of a New Diagnosis and Intervention Method for Developmental Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01166152
• Other study ID #: TokyoUAT_21_11
• Status: Recruiting
• Phase: N/A
• First received: July 19, 2010
• Last updated: July 20, 2011
• Start date: August 2010
• Est. completion date: March 2013

Study information

• Verified date: July 2010
• Source: Tokyo University of Agriculture and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Education, Culture, Sports, Science and TechnologyJapan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2013
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 50 Years

Eligibility

Inclusion Criteria:

• Developmental disorders

Exclusion Criteria:

• Mental retardation

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Developmental Disabilities

Intervention

Behavioral:
• social skills training
meeting once a week or biweekly to play together using toys, games, and physical exercises.

Locations

Country	Name	City	State
Japan	Ashiya University Graduate School of Clinical Education	Ashiya	Hyogo

Sponsors (3)

Lead Sponsor	Collaborator
Tokyo University of Agriculture and Technology	Ashiya University, Saitama Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at least 8 weeks after intervention	No
Secondary	view direction	The subject view direction will be monitored using the video camera (Sony) during clinical interview.	at least 8 weeks after intervention	No