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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024831
Receipt No. R000028571
Scientific Title A research for clinical application of real-time functional magnetic resonance imaging neurofeedback for treatment of schizophrenia
Date of disclosure of the study information 2017/02/01
Last modified on 2016/11/14

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Basic information
Public title A research for clinical application of real-time functional magnetic resonance imaging neurofeedback for treatment of schizophrenia
Acronym A research for clinical application of real-time functional magnetic resonance imaging neurofeedback for treatment of schizophrenia
Scientific Title A research for clinical application of real-time functional magnetic resonance imaging neurofeedback for treatment of schizophrenia
Scientific Title:Acronym A research for clinical application of real-time functional magnetic resonance imaging neurofeedback for treatment of schizophrenia
Region
Japan

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

Objectives
Narrative objectives1 Our objective is to change functional brain connectivity selected with data-driven analysis, using real-time functional magnetic resonance imaging neurofeedback (NFB), and evaluate the efficacy and safety of NFB.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Positive and Negative Symptoms Scale (PANSS)
Key secondary outcomes The Global Assessment of Functioning (GAF)
The Brief Assessment of Cognition in Schizophrenia (BACS)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 One NFB session in fMRI scanner will be conducted once a day, and 5 days a week. After 5-10 sessions (in one or 2 weeks), symptoms and conditions of participants will be evaluated.
Interventions/Control_2
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
50 years-old >
Gender Male and Female
Key inclusion criteria 1. Participants need to be outpatients of department of psychiatry, Kyoto University.
2. Participants need to be diagnosed as schizophrenia and other psychotic disorders, or schizophrenia spectrum in DSM-IV-TR or DSM-V.
3. Participants need to have normal or corrected visual acuity.
4. Age at the time of enrolment need to be over 20 years old and under 50 years old.
5. Participants need to give informed consent by themselves on paper.
Key exclusion criteria 1. User of cardiac pacemaker
2. User of brain vascular clip
3. User of electric stimulator for neurons
4. User of implanted pump in body
5. One having remaining metallic piece in one's body
6. One having tattoo
7. One having treatment with electroconvulsive therapy
8. One having comorbid disorder below,
Seizure or other neurological disease
Substance related disorders
Severe heart disease
9. One having past history below,
Seizure or other neurological disease
Substance related disorders
Brain injury with loss of consciousness
10. Female having possibility of pregnancy. Female having breast-feeding. Male of Female not using birth control during research
11. One having been judged as inappropriate for research by researcher and doctors.

Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidehiko Takahashi
Organization Kyoto University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 54 Shogoin-Kawara-cho Sakyo-ku Kyoto
TEL 0757513386
Email hidehiko@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidehiko Takahashi
Organization Kyoto University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 54 Shogoin-Kawara-cho Sakyo-ku Kyoto
TEL 0757513386
Homepage URL
Email hidehiko@kuhp.kyoto-u.ac.jp

Sponsor
Institute Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology (MEXT)
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
Address
Tel
Email

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
2017 Year 02 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 Preinitiation
Date of protocol fixation
2017 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 14 Day
Last modified on
2016 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028571

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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