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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041293
Receipt No. R000047114
Scientific Title A study of the effects of auditory and visual training on cognitive impairment in schizophrenia
Date of disclosure of the study information 2020/08/03
Last modified on 2020/08/03

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Basic information
Public title A study of the effects of auditory and visual training on cognitive impairment in schizophrenia
Acronym A study of the effects of perceptual training in schizophrenia
Scientific Title A study of the effects of auditory and visual training on cognitive impairment in schizophrenia
Scientific Title:Acronym A study of the effects of perceptual training in schizophrenia
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the effects of auditory and visual perceptual training in schizophrenia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery after 8 weeks
Key secondary outcomes Schizophrenia Cognition Rating Scale (SCoRS)
Specific Level of Functioning Assessment(SLOF)
Positive and Negative Syndrome Scale (PANSS)
Amplitude of auditory mismatch negativity
Gamma activity during auditory steady state response (ASSR) paradigm

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Auditory or visual perceptual training using BrainHQ. Individual session takes 1 hour in a day. Subjects take totally 40 hour session duaring 8 weeks.
Interventions/Control_2 Visual perceptual training using BrainHQ. Individual session takes 1 hour in a day. Subjects take totally 40 hour session duaring 8 weeks.
Interventions/Control_3 treatment as usual
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1.Participants with a diagnosis of schizophrenia according to DSM-5 criteria
2.Clinically stable participants. Clinically stable is defined as having had no delusions or hallucinations and no significant deterioration in motivation during the six months prior to participation in the study. Any medication is acceptable for participation in this study.
3.Participants with sufficient Japanese language ability
4.Participants who have been fully briefed on the study, fully understood, and have given their voluntary written consent to participate in the study.
Key exclusion criteria 1.Participants with a history of neurological disease with organic abnormalities in the central nervous system
2.Participants with serious cardiovascular, respiratory, gastrointestinal, renal, endocrine, or other diseases
3.Participants with co-morbidities related to visual and hearing impairments
4.Participants who are deemed by the principal investigator to be unsuitable as research subjects
Target sample size 76

Research contact person
Name of lead principal investigator
1st name Toyomaki
Middle name Toyomaki
Last name Atsuhito
Organization Graduate school of Medicine. Hokkaido University
Division name Department pf Psychiatry
Zip code 060-8638
Address Kita-ku, Kita15, Nishi7, Sapporo, Japan
TEL 0117065160
Email toyomaki@gmail.com

Public contact
Name of contact person
1st name Toyomaki
Middle name
Last name Atsuhito
Organization Graduate school of Medicine. Hokkaido University
Division name Department pf Psychiatry
Zip code 060-8638
Address Kita-ku, Kita15, Nishi7, Sapporo, Japan
TEL 0117065160
Homepage URL
Email toyomaki@gmail.com

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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 Hokkaido University Certified Review Board
Address Kita-ku, Kita14, Nishi5, Sapporo, Japan
Tel 011-701-7636
Email crjimu@huhp.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
2020 Year 08 Month 03 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
2020 Year 07 Month 20 Day
Date of IRB
2020 Year 07 Month 20 Day
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2022 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
2020 Year 08 Month 03 Day
Last modified on
2020 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047114

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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