UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041293
Receipt number 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 2024/03/04 10:25:08

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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 or person

Institute

Hokkaido University

Institute

Department

Personal name



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

Open public recruiting

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

2025 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

2024 Year 03 Month 04 Day



Link to view the page

Value
https://center6.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