UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024831
Receipt number 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 2022/11/21 15:06:53

* 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

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

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

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

N-back cognitive training for approximately one hour per day, five days per week.

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 Jun
Middle name
Last name Miyata

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Psychiatry

Zip code

606-8507

Address

54 Shogoin-Kawara-cho Sakyo-ku Kyoto

TEL

0757513386

Email

miyata10@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Jun
Middle name
Last name Miyata

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Psychiatry

Zip code

606-8507

Address

54 Shogoin-Kawara-cho Sakyo-ku Kyoto

TEL

0757513386

Homepage URL


Email

miyata10@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University

Institute

Department

Personal name



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

Advanced Telecommunications Research Institute International (ATR)

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

53, Kawahara-tyo, Syogo-in, Sakyo-ku, Kyoto 606-8507, Japan

Tel

075-753-4680

Email

ethcomkuhp@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



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

Suspended

Date of protocol fixation

2017 Year 02 Month 01 Day

Date of IRB

2017 Year 02 Month 14 Day

Anticipated trial start date

2017 Year 03 Month 01 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

2016 Year 11 Month 14 Day

Last modified on

2022 Year 11 Month 21 Day



Link to view the page

Value
https://center6.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