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 2022/09/07 17:43:57

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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

Email

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

Preinitiation

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

2022 Year 09 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055691


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name