UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000032541
Receipt number R000037112
Scientific Title Effect of combined working memory and attention training in healthy adults
Date of disclosure of the study information 2018/05/15
Last modified on 2022/08/23 13:34:56

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Basic information

Public title

Effect of combined working memory and attention training in healthy adults

Acronym

Effect of combined working memory and attention training in healthy adults

Scientific Title

Effect of combined working memory and attention training in healthy adults

Scientific Title:Acronym

Effect of combined working memory and attention training in healthy adults

Region

Japan


Condition

Condition

healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the changes in neuropsychological test performance, and the morphological and functional changes of the brain, following neurocognitive training in healthy adults.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Percentage of correct answers in the PASAT score before and after the neurocognitive training and the magnitude of change in the scores

Key secondary outcomes

1.Pre- and post-neurocognitive training neuropsychological test results (trail making test part A and B, digit span test, tapping span test, standard verbal paired-associate learning test scores)and the magnitude of change
2.Pre- and post-training morphological and functional imaging results and the magnitude of change
3.Correlation between the morphological and functional imaging results and the neuropsychological performance (the magnitude of change in each score before and after training)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Experiment1(Training effect)
Neurocognitive training
1 hour/session, 5 sessions/week for 4 weeks, a total of 20 hours

Interventions/Control_2

Experiment1
Training skipped

Interventions/Control_3

Experiment2(Assessment of brain structure
and function)
*After Experiment1
Neurocognitive training
1 hour/session, 5 sessions/week for 4 weeks, a total of 20 hours

Interventions/Control_4

Experiment2
*After Experiment1
Training skipped

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

55 years-old >=

Gender

Male and Female

Key inclusion criteria

Those patients who gave informed consent based on own will

Key exclusion criteria

1.Psychological or neurological disorders which affect the neuropsychological test performance
2.Vision or hearing impairment or motor disability which affects the neuropsychological test performance
3.Contraindications for MRI (cardiac pacemaker, inner ear implant, claustrophobia, etc.)

Target sample size

69


Research contact person

Name of lead principal investigator

1st name Daisuke
Middle name
Last name Sawamura

Organization

Faculty of Health Sciences, Hokkaido University

Division name

Department of Functioning and Disability

Zip code

060-0812

Address

Kita12, Nishi5, Kita-ku, Sapporo

TEL

011-706-3387

Email

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


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Sawamura

Organization

Faculty of Health Sciences, Hokkaido University

Division name

Department of Functioning and Disability

Zip code

060-0812

Address

Kita12, Nishi5, Kita-ku, Sapporo

TEL

011-706-3387

Homepage URL


Email

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


Sponsor or person

Institute

Faculty of Health Sciences, Hokkaido University
Department of Functioning and Disability

Institute

Department

Personal name



Funding Source

Organization

Faculty of Health Sciences, Hokkaido University
Department of Functioning and Disability

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

Institutional Review Board of health sciences ,Hokkaido University

Address

kita-12, nishi-5, Kita-ku

Tel

0117063316

Email

shomu*hs.hokudai.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

2018 Year 05 Month 15 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

31

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

No longer recruiting

Date of protocol fixation

2018 Year 05 Month 15 Day

Date of IRB

2018 Year 05 Month 22 Day

Anticipated trial start date

2018 Year 05 Month 24 Day

Last follow-up date

2020 Year 03 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

2018 Year 05 Month 10 Day

Last modified on

2022 Year 08 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037112


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name