UMIN-ICDS Clinical Trial

Public title

The Effects of Dual Task Interference Effects and Neural Basis in Drawing Tasks and the Paced Auditory Serial Addition Test.

Acronym

The Effects of Dual Task Interference Effects and Neural Basis in Drawing Tasks and the Paced Auditory Serial Addition Test.

Scientific Title

The Effects of Dual Task Interference Effects and Neural Basis in Drawing Tasks and the Paced Auditory Serial Addition Test.

Scientific Title:Acronym

The Effects of Dual Task Interference Effects and Neural Basis .

Region

Japan

Condition

Healthy Adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate interference effects, brain activity and neural networks during a dual task of simultaneous motor and cognitive tasks

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Motor task: average velocity of spirals drawn against a model spiral, deviation distance (accuracy)
Cognitive task: Percent correct on PASAT
Brain activity: brain activity measured by fNIRS

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

18

years-old

<=

Age-upper limit

30

years-old

>

Gender

Male and Female

Key inclusion criteria

Right-handed healthy adult

Key exclusion criteria

No history or current history of psychiatric or neurological disorders
Persons who have given their consent in writing.

Target sample size

34

Name of lead principal investigator

1st name	Daisuke
Middle name
Last name	Sawamura

Organization

Faculty of Health Sciences, Hokkaido University

Division name

Rehabilitation Science

Zip code

060-0812

Address

Kita12-jo nishi5-chome Kita-ku Sapporo, Hokkaido, Japan

TEL

011-706-3387

Email

D.sawamura@pop.med.hokudai.ac.jp

Name of contact person

1st name	Daisuke
Middle name
Last name	Sawamura

Organization

Faculty of Health Sciences, Hokkaido University

Division name

Rehabilitation Science

Zip code

060-0812

Address

Kita12-jo nishi5-chome Kita-ku Sapporo, Hokkaido, Japan

TEL

011-706-3387

Homepage URL

Email

D.sawamura@pop.med.hokudai.ac.jp

Institute

Hokkaido University

Institute

Department

Personal name

Organization

Hokkaido University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical review board of Faculty of Health Sciences, Hokkaido University

Address

Kita12-jo nishi5-chome Kita-ku Sapporo, Hokkaido, Japan

Tel

011-706-3316

Email

Shomu@hs.hokudai.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

北海道医療大学

Date of disclosure of the study information

2022

Year

10

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2022

Year

10

Month

13

Day

Date of IRB

Anticipated trial start date

2022

Year

10

Month

18

Day

Last follow-up date

2023

Year

01

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Subjects will be recruited using bulletin boards on the campuses of Hokkaido University and Hokkaido University of Health Sciences, and by posting and distributing flyers.
Methods: The cognitive tasks used were the PASAT 1-second condition (PASAT-1s) and the PASAT 2-second condition (PASAT-2s). The PASAT is an auditory working memory task in which participants are asked to add a single digit to a sequence of spoken digits presented every unit of time, and the correct response rate per execution is calculated. The motor task is a spiral drawing task using a tablet with the non-dominant hand, which is traced with a stylus so as not to deviate from the model spiral presented on the screen. During the exercise, the next spiral is presented in succession immediately after the target spiral is finished, and the average speed and deviation distance from the model spiral are measured during each execution. The results of the drawing task are converted to a combined measure of average speed and accuracy and compared. The ST condition consists of 1) drawing task, 2) PASAT-1s, and 3) PASAT-2s, and the DT condition consists of 4) drawing task + PASAT-1s and 5) drawing task + PASAT-2s. Each execution will last for 1 minute, and each condition will be performed 3 times each (total 22 minutes including breaks for all 15 blocks of tasks). The order of execution will be counterbalanced in consideration of the learning effect.
Translated with www.DeepL.com/Translator (free version)

Registered date

2022

Year

10

Month

13

Day

Last modified on

2022

Year

10

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056051