UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047318 |
|---|---|
| Receipt number | R000052351 |
| Scientific Title | Event-related EEG alpha-band power changes during working memory and self-reflection tasks in healthy individuals and attention deficit hyperactivity disorder. |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2025/11/25 09:32:40 |
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Basic information
Public title
Event-related EEG alpha-band power changes during working memory and self-reflection tasks in healthy individuals and attention deficit hyperactivity disorder.
Acronym
EEG alpha-band power changes during WM/SR tasks in ADHD.
Scientific Title
Event-related EEG alpha-band power changes during working memory and self-reflection tasks in healthy individuals and attention deficit hyperactivity disorder.
Scientific Title:Acronym
EEG alpha-band power changes during WM/SR tasks in ADHD.
Region
| Japan |
Condition
Condition
Attention-Deficit/Hyperactivity Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether alpha-band event-related power changes(ERpow) serve as a physiological marker for ADHD, alpha-band ERpow during working memory(WM)/self-reflection(SR) tasks are investigated. This study confirms whether alpha-band ERpow in SR condition significantly differs from those in WM condition in healthy subjects. Then, whether such discrepancy is not remarkable in ADHD patients is examined.
Basic objectives2
Others
Basic objectives -Others
Bio-usefulness of alpha-band event-related power changes(ERpow) in the diagnostic process for ADHD.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Alpha-band event-related power changes(ERpow)
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 English adjective words.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy subjects and ADHD patients who are over 18 years old, right-handed, and have an education of over 12 years.
Key exclusion criteria
Those who are under the influence of psychotropic drugs, those who have other psychiatric disorders, those who are FSIQ of 70 or less, those who have a history of heavy alcohol consumption, those who have an account of head injury or impaired consciousness, those who have thyroid dysfunction, those who have a vitamin deficiency, those who have an organic brain disease, those who have a severe physical illness, those who are judged unsuitable as a subject.
Target sample size
36
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)
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
tmatsu@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama medical university hospital Institutional review board
Address
338 Morohongo, Moroyama-machi, Iruma-gun, Saitama, JAPAN
Tel
049-276-1354
hirb@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
| 2022 | Year | 03 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 29 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052351
