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
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
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
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
