UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048876 |
|---|---|
| Receipt number | R000055691 |
| Scientific Title | Effectiveness and Safety of a Virtual Reality-based Prospective Memory Training System |
| Date of disclosure of the study information | 2022/09/12 |
| Last modified on | 2024/05/13 16:58:07 |
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Basic information
Public title
Effectiveness and Safety of a Virtual Reality-based Prospective Memory Training System
Acronym
Effectiveness and Safety of a Virtual Reality-based Prospective Memory Training System
Scientific Title
Effectiveness and Safety of a Virtual Reality-based Prospective Memory Training System
Scientific Title:Acronym
Effectiveness and Safety of a Virtual Reality-based Prospective Memory Training System
Region
| Japan |
Condition
Condition
Healthy persons (including the elderly)
Schizophrenia
Higher brain dysfunction
Classification by specialty
| Psychiatry | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of VR-based prospective memory training on prospective memory in the elderly, schizophrenics, and persons with higher brain dysfunction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Memory for Intentions Test; MIST
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Individualized VR prospective memory training will be provided once a week for 8 weeks. Measure psychological functioning at three time points (pre, post, and follow-up).
Interventions/Control_2
Individualized VR prospective memory training will be provided once a week for 8 weeks. Measure psychological functioning at three time points (pre, post, and follow-up).
Interventions/Control_3
Individualized VR prospective memory training will be provided once a week for 8 weeks. Measure psychological functioning at three time points (pre, post, and follow-up).
Interventions/Control_4
Individualized VR prospective memory training will be provided once a week for 8 weeks. Measure psychological functioning at three time points (pre, post, and follow-up).
Interventions/Control_5
Psychological functioning measures will be taken according to the intervention group.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Consent to participate in the study with consent form
(2)Non-intervention group is between 18 and 90 years old; Nonelderly intervention group is at least 18 years old but less than 59 years old; Elderly intervention group is 60 to 90 years old; Other clinical patients intervention group is between 18 and 90 years old
(3)Brain injury group: diagnosed with higher brain dysfunction
Schizophrenia group: with clinically confirmed diagnosis of schizophrenia spectrum disorder
Key exclusion criteria
(1)Experienced adverse reactions due to VR
(2)Pregnant or lactating
(3)Persons who were judged to be inappropriate for inclusion in the study by the study investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kayoko |
| Middle name | |
| Last name | Miura |
Organization
Nagasaki Junshin Catholic University
Division name
Department of Comprehensive Community Care Service, Faculty of Humanities
Zip code
852-8558
Address
235 Mitsuyamamachi, Nagasaki, Nagasaki, Japan
TEL
0958460084
miura@n-junshin.ac.jp
Public contact
Name of contact person
| 1st name | Kayoko |
| Middle name | |
| Last name | Miura |
Organization
Nagasaki Junshin Catholic University
Division name
Department of Comprehensive Community Care Service, Faculty of Humanities
Zip code
852-8558
Address
235 Mitsuyamamachi, Nagasaki, Nagasaki, Japan
TEL
0958460084
Homepage URL
miura@n-junshin.ac.jp
Sponsor or person
Institute
Nagasaki Junshin Catholic University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science, and Technology-Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
長崎純心大学（長崎県）、京都大学医学部附属病院精神科神経科（京都府）、香川大学（香川県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 12 | 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
| 2022 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 09 | Month | 07 | Day |
Last modified on
| 2024 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055691
