UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029200
Receipt number 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 09:07:51

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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 or person

Institute

SHIONOGI &CO., LTD

Institute

Department

Personal name



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

Value
https://center6.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