UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043194 |
|---|---|
| Receipt number | R000049296 |
| Scientific Title | Neurofeedback study for the self-regulation of neural activities in patients with Schizophrenia |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2021/01/31 17:18:44 |
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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
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
nouseiri.ku@gmail.com
Sponsor or person
Institute
Kyushu university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049296
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