UMIN-CTR Clinical Trial

Basic information
Public title	Neurofeedback study for the self-regulation of neural activities in patients with Schizophrenia
Acronym	Neurofeedback study for the self-regulation of neural activities in patients with Schizophrenia
Scientific Title	Neurofeedback study for the self-regulation of neural activities in patients with Schizophrenia
Scientific Title:Acronym	Neurofeedback study for the self-regulation of neural activities in patients with Schizophrenia
Region	Japan

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

Objectives
Narrative objectives1	We aim to teach self-regulation of brain function to patients in Schizophrenia by using Neurofeedback (NFB), which displays real-time brain activity to the participants commonly by electroencephalography (EEG) and cognitive behavioral task. Participants are displayed sound stimuli (voice or pseud-voice) or visual stimuli (neutral or negative emotional pictures) and are measured electrical brain activity throughout the task.
Basic objectives2	Others
Basic objectives -Others	The protocol of this NFB task will be utilized for the diagnosis or treatment of psychiatric disorders.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between changes in auditory hallucination scores and auditory brain activity throughout the NFB training
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Schizophrenia Normal Control Run the same experiment for all
Interventions/Control_2	Schizophrenia Normal Control Run the same experiment for all
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	15 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	[Patients] 1. Men and women aged 15 to 65 2. Patients with Schizophrenic / Bipolar disorder / Major depressive disorder. 3. Diagnosis is by DSM-V 4. Diagnosis is performed by two or more psychiatrists, and if both diagnoses are different, they are excluded [Healthy Control] 1. Men and women aged 15 to 65
Key exclusion criteria	[Patients] 1. History of concussion or severe head injury 2. History of neurological disorder 2. History of electroconvulsive therapy 4. Alcohol dependence or drug dependence 5. Alcohol dependence or drug dependence in 5 years 6. Linguistic IQ is less than 75 7. Irreparable dysopia 8. When researcher determines that it is ineligible [Healthy Control] 1. History of concussion or severe head injury 2. History of neurological disorder 3. History of mental disorder in the first-degree family based on the information of the principal 4. History of use of a psychotropic medicine (mood stabilizer, antipsychotic medicine, etc.) 5. Linguistic IQ is less than 75 6. Irreparable dysopia 7. When researcher determines that it is ineligible
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Toshiaki Middle name Last name Onizuka
Organization	Kyushu university
Division name	Department of Neuropsychiatry Graduate School of Medical Sciences
Zip code	812-8582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka
TEL	092-642-5641
Email	nouseiri.ku@gmail.com

Public contact
Name of contact person	1st name Toshiaki Middle name Last name Onizuka
Organization	Kyushu university
Division name	Department of Neuropsychiatry Graduate School of Medical Sciences
Zip code	812-8582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka
TEL	092-642-5641
Homepage URL
Email	nouseiri.ku@gmail.com

Sponsor
Institute	Kyushu university
Institute
Department

Funding Source
Organization	Ministry of education
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	Institutional Review Board in Kyushu universty
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka
Tel	092-642-5082
Email	byskenkyu@jimu.kyushu-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	2021 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	2021 Year 01 Month 31 Day
Date of IRB	2020 Year 09 Month 28 Day
Anticipated trial start date	2021 Year 01 Month 31 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	2021 Year 01 Month 31 Day
Last modified on	2021 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049296