Development of a New Diagnosis and Intervention Method fo... | NCT01166152

Studies
Development of a New Diagnosis and Intervention Method for Developmental Disorders

NCT01166152

Sponsor

Tokyo University of Agriculture and Technology

Status

Unknown status

Last Update Posted

Jul 21, 2011Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Developmental Disabilities

Interventions

social skills training

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Nov 2011Estimated

Completion Date

Mar 2013Estimated

First Submitted Date

Jul 19, 2010

First Submission Date that Met QC Criteria

Jul 19, 2010

First Posted Date

Jul 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2011

Last Update Posted Date

Jul 21, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Tokyo University of Agriculture and TechnologyOTHER

Collaborators

Name	Class
Ashiya University	OTHER
Saitama Medical University	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
social skills training	Behavioral	meeting once a week or biweekly to play together using toys, games, and physical exercises.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
view direction	The subject view direction will be monitored using the video camera (Sony) during clinical interview.	at least 8 weeks after intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Developmental disorders

Exclusion Criteria:

Mental retardation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ashiya University Graduate School of Clinical Education	Recruiting	Ashiya	Hyōgo	659-8511	Japan

Condition Browse Module

MeSH Terms

ID	Term
D002658	Developmental Disabilities
D000067877	Autism Spectrum Disorder

Ancestor Terms

ID	Term
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders
D002659	Child Development Disorders, Pervasive

Browse Leaves

Not provided

Browse Branches

Not provided