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Development of a New Diagnosis and Intervention Method for Developmental Disorders

Development of a New Diagnosis and Intervention Method for Developmental Disorders

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01166152
Acronym
DIDD
Enrollment
20
Registered
2010-07-20
Start date
2010-08-31
Completion date
2013-03-31
Last updated
2011-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Developmental Disabilities

Keywords

autistic spectrum disorders, developmental disorders

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.

Interventions

BEHAVIORALsocial skills training

meeting once a week or biweekly to play together using toys, games, and physical exercises.

Sponsors

Ashiya University
CollaboratorOTHER
Saitama Medical University
CollaboratorOTHER
Tokyo University of Agriculture and Technology
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
No minimum to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Developmental disorders

Exclusion criteria

* Mental retardation

Design outcomes

Primary

MeasureTime frameDescription
thermogram of headat least 8 weeks after interventionThe 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

MeasureTime frameDescription
view directionat least 8 weeks after interventionThe subject view direction will be monitored using the video camera (Sony) during clinical interview.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026