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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029200
Receipt No. R000033208
Scientific Title Evaluation of diagnostic subsystem for neurodevelopmental disorders (ASD, ADHD) using wearable NIRS.
Date of disclosure of the study information 2017/09/23
Last modified on 2018/09/23

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Basic information
Public title Evaluation of diagnostic subsystem for neurodevelopmental disorders (ASD, ADHD) using wearable NIRS.
Acronym Diagnose of ASD, ADHD using NIRS.
Scientific Title Evaluation of diagnostic subsystem for neurodevelopmental disorders (ASD, ADHD) using wearable NIRS.
Scientific Title:Acronym Diagnose of ASD, ADHD using NIRS.
Region
Japan

Condition
Condition Autism spectrum disorder, Attention-deficit/hyperactivity disorders
Classification by specialty
Neurology Psychosomatic Internal Medicine Pediatrics
Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to establish a reliable sub-diagnostic system of neurodevelopmental disorders, such as ASD and ADHD.
Those disorders are known as majority
of social-behavioral disorders, through child to adulthood, which cause various grade of difficulties in social-life.
We previously found that ASD
patients delayed in response to the task-switch which requires prefrontal cortex activation and deactivation, and established a subdiagnostic and analytic method using wearable NIRS.
Purpose of this present study is to evaluate this subdiagnostic measurement using expanded number of patients and Typically developed, to confirm our new method as an reliable biomarker of ASD, ADHD, and related neurodevelopmental disorders.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes We measure oxy-Hb, deoxy-Hb, and total-Hb, using wearable NIRS, and the data will be processed to evaluate the activation-deactivation pattern of the prefrontal cortex. Also we will ask the participants to fill out the questionnaire to confirm the psychological status of their disorders. Collected data will be analyzed within 6 months from the measurement.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Developmental disorders:
Measurement of prefrontal cortex oxy-Hb concentration during executive functional activating / non-activating switching task performance in ASD
/ADHD patients.The measurement is planned to be done basically one time per one person.
Interventions/Control_2 Typically developed:
Measurement of prefrontal cortex oxy-Hb concentration during executive functional activating / non-activating switching task performance in typically developed individuals.The measurement is planned to be done basically one time per one person.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
6 years-old <=
Age-upper limit
55 years-old >=
Gender Male and Female
Key inclusion criteria Developmental disorders:
Those who voluntary participate in the study, with no history of treatment with psychotropic drugs.
Those who are diagnosed as ASD or ADHD. Those who scored 12 points or up by ADHD-RS-IV.
Typically developed:
Those who are not diagnosed as developmental disorders.
Key exclusion criteria Developmental disorders:
Those who takes ADHD remedy.
Typically developed:
Those who are suspected as developmental disorders.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoko Narita
Organization Bunkyo University
Division name Institute of Education
Zip code
Address 3337 Minamiogishima, Koshigaya, Saitama
TEL 048-974-8960
Email nnarita@koshigaya.bunkyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahito Higashiura
Organization SHIONOGI &CO., LTD
Division name Biomarker R6D Department
Zip code
Address 3-1-1, Futaba-cho, Toyonaka, Osaka
TEL 06-6331-5966
Homepage URL
Email masahito.higashiura@shionogi.co.jp

Sponsor
Institute SHIONOGI &CO., LTD
Institute
Department

Funding Source
Organization SHIONOGI &CO., LTD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Nihon University, College of Industrial Technology, Department of Mechanical Engineering.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We performed the planned experiment using NIRS on 13 TDs and 16 ASD/ADHD participants. Although it was difficult to segregate ASD/ADHD from TD as total paraticipant's group, we obtained approximately 70% diagnostic accuracy using three combined parameters when participants were divided in two groups according to their age. 
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 23 Day
Last follow-up date
2018 Year 06 Month 30 Day
Date of closure to data entry
2018 Year 06 Month 30 Day
Date trial data considered complete
2018 Year 06 Month 30 Day
Date analysis concluded
2018 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 20 Day
Last modified on
2018 Year 09 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033208

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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