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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032541
Receipt No. 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 2019/05/24

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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 Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Neurocognitive training
1 hour/session, 5 sessions/week for 4 weeks, a total of 20 hours
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
65 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 13

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

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
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
2018 Year 05 Month 15 Day
Date of IRB
2018 Year 06 Month 01 Day
Anticipated trial start date
2018 Year 08 Month 01 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
2019 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_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


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