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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024350
Receipt No. R000028037
Scientific Title Event-related alpha-band EEG synchronization/desynchronization during working memory/self reflection task in healthy human subject.
Date of disclosure of the study information 2016/10/11
Last modified on 2019/03/30

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Basic information
Public title Event-related alpha-band EEG synchronization/desynchronization during working memory/self reflection task in healthy human subject.
Acronym alpha-band ERS/ERD during WM/SR task.
Scientific Title Event-related alpha-band EEG synchronization/desynchronization during working memory/self reflection task in healthy human subject.
Scientific Title:Acronym alpha-band ERS/ERD during WM/SR task.
Region
Japan

Condition
Condition Attention deficit hyperactivity disorder(ADHD) as target population.
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify whether alpha-band ERS/ERD serve as physiological marker for ADHD, alpha-band ERS/ERD during working memory(WM)/self-reflection(SR) task are investigated.
In this study, whether alpha-band ERS/ERD in SR condition significantly differ from those in WM condition is examined in healthy subjects. In future, whether such discrepancy is not remarkable in ADHD patients will be examined.
Basic objectives2 Others
Basic objectives -Others Bio-usefulness of alpha-band ERS/ERD in diagnostic process for ADHD.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Alpha-band ERD/ERS
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Behavior,custom
Interventions/Control_1 Perform working memory task using Japanese adjectival verb.
1.Perform self-reflection task using Japanes2.e adjectival verb.
3.Perform working memory task using English adjective words.
4.Perform self-reflection task using English adjective words.
Interventions/Control_2
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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male
Key inclusion criteria Right-handed Right-handed healthy adult men.healthy adult men.
Key exclusion criteria Woman
Man who is under influence of psychotropics/minor, left-handed.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Matsuoka
Organization Saitama Medical University
Division name Saitama Medical University Hospital, Department of Psychiatry
Zip code 350-0495
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, JAPAN
TEL 049-276-1111(ext.2163)
Email tmatsu@saitama-med.ac.jp

Public contact
Name of contact person
1st name Takahiro
Middle name
Last name Matsuoka
Organization Saitama Medical University
Division name Saitama Medical University Hospital, Department of Psychiatry
Zip code 350-0495
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, JAPAN
TEL 049-276-1111(ext.2163)
Homepage URL
Email tmatsu@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University Hospital,
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saitama medical university ethical review board.
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, JAPAN
Tel 049-276-1211-3188
Email rinri@saitama-med.ac.jp

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
2016 Year 10 Month 11 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
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 Open public recruiting
Date of protocol fixation
2016 Year 09 Month 05 Day
Date of IRB
2016 Year 12 Month 16 Day
Anticipated trial start date
2017 Year 01 Month 06 Day
Last follow-up date
2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 11 Day
Last modified on
2019 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028037

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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