UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049670 |
|---|---|
| Receipt number | R000056571 |
| Scientific Title | Effects of n-back tasks with the same content but different stimulus modalities on brain activity and fatigue |
| Date of disclosure of the study information | 2022/12/05 |
| Last modified on | 2023/10/18 12:32:16 |
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Basic information
Public title
Effects of n-back tasks with the same content but different stimulus modalities on brain activity and fatigue
Acronym
Effects of n-back tasks with the same content but different stimulus modalities on brain activity and fatigue
Scientific Title
Effects of n-back tasks with the same content but different stimulus modalities on brain activity and fatigue
Scientific Title:Acronym
Effects of n-back tasks with the same content but different stimulus modalities on brain activity and fatigue
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effects of performing n-back tasks with the same content and different loading stimulus modalities on brain activity and fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain activity (prefrontal cortex )
near-infrared spectroscopy
Key secondary outcomes
fatigue
Task Reaction Time
Percentage of tasks answered correctly
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Spatial n-back task
Each assignment consisted of 20 blocks. The block included 23 trials (five targets) in the 3-back.
Interventions/Control_2
Auditory n-back task
Each assignment consisted of 20 blocks. The block included 23 trials (five targets) in the 3-back.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria for the healthy adults in this study were as follows:
(a) Ages of over 18, irrespective of gender
(b) Not taking any psychotropic drugs for at least one year
(c) average vision and no hearing problems.
Key exclusion criteria
Exclusion criteria include those who cannot read written text even with vision correction due to visual impairment, those who cannot respond to auditory stimuli due to hearing impairment, and those who require medication due to fatigue syndrome or psychiatric factors.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Noguchi |
Organization
Suzuka University of Medical Science
Division name
Department of Rehabilitation, Faculty of Health Science
Zip code
510-0293
Address
Kishioka 1001-1, Suzuka City, Mie
TEL
059-383-8991
reha.noguchi.ot@gmail.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Noguchi |
Organization
Suzuka University of Medical Science
Division name
Department of Rehabilitation, Faculty of Health Science
Zip code
510-0293
Address
Kishioka 1001-1, Suzuka City, Mie
TEL
059-383-8991
Homepage URL
reha.noguchi.ot@gmail.com
Sponsor or person
Institute
Suzuka University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Suzuka University of Medical Science
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
Suzuka University of Medical Science
Address
Minamitamagaki 3500-3, Suzuka City, Mie
Tel
059-340-0550
mayumi@suzuka-u.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
| 2022 | Year | 12 | Month | 05 | 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
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2022 | Year | 12 | Month | 02 | Day |
Last modified on
| 2023 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056571
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
