UMIN-CTR Clinical Trial

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

Attention deficit hyperactivity disorder(ADHD) as target population.

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Alpha-band ERD/ERS

Key secondary outcomes

Study type

Interventional

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

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

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

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

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

Institute

Saitama Medical University Hospital,

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

10

Month

11

Day

URL releasing protocol

https://www.frontiersin.org/articles/10.3389/fnhum.2020.570279/full

Publication of results

Published

URL related to results and publications

https://www.frontiersin.org/articles/10.3389/fnhum.2020.570279/full

Number of participants that the trial has enrolled

16

Results

The ERpow between S2 and S3 at parieto-occipital areas decreased in the WM task, while the ERpow increased in the SR task. Two-way ANOVA in the experiment using Japanese adjectival verbs revealed that the main effect of PERIOD and the interaction of PERIOD*TASK were significant in the upper alpha-band (p<0.01). Three-way ANOVA in the experiment using English adjectives revealed the main effect of PERIOD, and the interaction of PERIOD*TASK, and PERIOD*FREQUENCY was significant in PO4 (p<0.01).

Results date posted

2022

Year

11

Month

09

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Experiment using Japanese adjectival verbs
Twelve healthy subjects were studied. All subjects were right-handed, and the mean plus or minus SD age was 27.4 plus or minus 5.3 years. All subjects were male. Subjects were required to have a university degree as a minimum education requirement. No subjects had any psychiatric disorders including ADHD in a clinical interview by psychiatrists. Any subject with abnormal EEG findings suggesting epilepsy and other organic brain disorders was excluded from the study by a psychiatrist with the certification of EEG expertise by the Japanese Society of Clinical Neurophysiology.
Experiment using English adjectives
Sixteen healthy subjects were studied. All subjects were right-handed, and the mean plus or minus SD age was 27.4 plus or minus 4.6 years. All subjects were male. Subjects were required to have a university degree as a minimum education requirement. No subjects had any psychiatric disorders including ADHD in a clinical interview by psychiatrists. Any subject with abnormal EEG findings suggesting epilepsy and other organic brain disorders was excluded from the study by a psychiatrist with the certification of EEG expertise by the Japanese Society of Clinical Neurophysiology.

Participant flow

For each subject, the experiment that consisted of eight blocks was performed after a clinical interview by psychiatrists. Four blocks were the WM task, while the remaining four were the SR task. Each block was 9 min, and the interval between blocks was 5 min.

Adverse events

no remarkable adverse events.

Outcome measures

Experiment using Japanese adjectival verbs
1. Performance Data (1) Reaction Time: The mean reaction time was 321 plus or minus 76ms in the 'GO' condition in the WM task and 356 plus or minus 104ms in the 'Match' condition in the SR task. The mean reaction time tends to be longer in the SR task compared to in the　WM task(F=2.7, p=0.1). (2a) Accuracy in the WM task: Accuracy in the WM task was 96.4% in the 'Go' condition and 99.8% in the 'No Go' condition. Participants correctly performed the　WM task with a rate of over 95%. (2b) The Discrepancy Rate in the SR Task: All subjects clicked on a word in the 'Match' condition in the SR task. The rate of the top three selected words was 44.4% in the 'Match' condition and 9.1% in the 'No Match' condition. The discrepancy of the two rates was statistically significant (F=184.2, p<0.001), which meant that the task was properly performed in the subjects. 2. ERP For the negative components, the peak amplitude was greatest after S2 in the WM and SR task. For the positive component, the peak latency after S2 was the longest in the WM and SR task.
Experiment using English adjectives
1. Performance Data (1) Reaction Time: The mean reaction time was 323 plus or minus 114 ms in the 'Go' condition in the WM task and 397 plus or minus 171ms in the 'Match' condition in the SR task. The mean reaction time was significantly longer in the SR task compared to in the WM task (F=5.0, p=0.03). (2a) Accuracy in the WM task: Accuracy in the WM task was 97.6% in the 'Go' condition and 99.6% in the 'No Go' condition. Participants correctly performed the WM task with a rate of over 95%. (2b)The Discrepancy Rate in the SR Task: All subjects clicked on a word in the 'Match' condition in the SR task. The rate of the top three selected words was 38.9% in the 'Match' condition and 13.9% in the 'No Match' condition. The discrepancy of the two rates was statistically significant (F=4.2, p<0.001), which meant that the task was properly performed in the subjects. 2. ERP For the negative components, the peak amplitude was greatest after S2 in the WM and SR task. For the positive component, the peak latency after S2 was the longest in the WM and SR task.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

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

2021

Year

03

Month

21

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

EEG data during working memory/serlf-reflection task using Japanese adjectival verbs was analyzed. The result was published on April,2019 on Japanese Journal of Clinical Neurophysiology.
On the other hands, EEG data during working memory/serlf-reflection task using English adjective verbs was published on Jan,2021 on Frontiers in Human Neuroscience.

Registered date

2016

Year

10

Month

11

Day

Last modified on

2022

Year

11

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028037