UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055868 |
|---|---|
| Receipt number | R000063853 |
| Scientific Title | Effects of virtual reality game using Leap Motion Controller on working memory and brain activity - A crossover trials- |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2026/06/04 19:30:18 |
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Basic information
Public title
Effects of virtual reality game using Leap Motion Controller on working memory and brain activity - A crossover trials-
Acronym
Effects of virtual reality game using Leap Motion Controller on working memory and brain activity
Scientific Title
Effects of virtual reality game using Leap Motion Controller on working memory and brain activity - A crossover trials-
Scientific Title:Acronym
Effects of virtual reality game using Leap Motion Controller on working memory and brain activity
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 verify by crossover trials how virtual reality games with the Leap Motion Controller induce changes in working memory performance and brain activity in the frontal lobes during working memory tasks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Event Related Potentials, N-back task
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
virtual reality game using the Leap Motion Controller
Interventions/Control_2
Non-virtual reality game
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
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Right-handed, native language is Japanese
Key exclusion criteria
Diagnosis of cranial nerve disease, psychiatric disease, developmental disorder, visual field defect, color blindness, and upper limb dysfunction.
Predicting intelligence quotient of 80 or less as calculated by the Japanese Adult Reading Test.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Annaka |
Organization
Niigata university of Health and welfare
Division name
Department of Occupational Therapy
Zip code
950-3198
Address
1398, Shimami-cho, Kita-ku, Niigata
TEL
025-257-4455
hiroki-annaka@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Annaka |
Organization
Niigata University of Health and Welfare
Division name
Department of Occupational Therapy
Zip code
950-3198
Address
1398, Shimami-cho, Kita-ku, Niigata
TEL
025-257-4455
Homepage URL
hiroki-annaka@nuhw.ac.jp
Sponsor or person
Institute
Niigata university of Health and Welfare, Department of Occupational Therapy, Hiroki Annaka
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University Health and Welfare
Address
1398 Shimami-chou, Kita-ku, Niigata
Tel
025-257-4455
rinri@nuhw.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
| 2024 | Year | 12 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 10 | Month | 17 | Day |
Last modified on
| 2026 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063853
