UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037112