UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of near-infrared spectroscopy neurofeedback for psychiatric disorders
Acronym	Effectiveness of NIRS-based neurofeedback
Scientific Title	Effectiveness of near-infrared spectroscopy neurofeedback for psychiatric disorders
Scientific Title:Acronym	Effectiveness of NIRS-based neurofeedback
Region	Japan

Condition
Condition	Major depression, Bipolar disorder, Anxiety disorder, Autism spectrum disorder, Attention-deficit/hyperactivity disorder, and Healthy control
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The therapeutic effect of antidepressants for depression is reported to be about 30% in remission rate. Other treatments include electroconvulsive therapy (ECT), recurrent transcranial magnetic stimulation (rTMS), deep brain stimulation (DBS) but they have disadvantages of high invasiveness. Neurofeedback (NFB) is an emergent approach that has been adopted in recent years as a potential intervention for a number of psychiatric disorders. In the NFB study using fMRI, it has been reported that clinical symptoms of mental disorders may be improved by repeating the training to change the neural activity of a specific brain region associated with disease. In recent years, NFB research using NIRS has also been observed (Kinoshita et al., 2016). As a mechanism of NIRS-based NFB, we aim to improve the neural network impairments that connect the frontal lobe, limbic system, and the basal ganglia directly by continuing training to selectively activate an region of the frontal lobe. In this study, we aim to establish the usefulness of NFB training by NIRS for psychiatric disorders.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1 Clinical evaluation scale HAM-D, HAM-A, MADRAS, etc. 2 Neuropsychological examination TMT, BADS, CAT, CANTAB, etc.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	We conduct a maximum of 20 NFB at a pace of 2-5 days per week.
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	16 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1 Patient group People who were diagnosed with major depression, bipolar disorder, anxiety disorder, ASD, ADHD in DSM-5 2 Healthy control group A healthy person without a history of mental illness
Key exclusion criteria	People who satisfies one of the following 1 Combined circulatory organ, liver, kidney, respiratory organs, blood, endocrine, central nervous system diseases, and person who was judged to be extremely unstable 2 Person who has history of head trauma or substance dependence 3 People with a history of epilepsy or generalized convulsions 4 For healthy control subjects, those who are diagnosed with developmental disorder
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Bun Middle name Last name Yamagata
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Zip code	160-8582
Address	35 Shinanomachi Shinjuku-Ku, Tokyo
TEL	03-5363-3971
Email	yamagata@a6.keio.jp

Public contact
Name of contact person	1st name Bun Middle name Last name Yamagata
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Zip code	160-8582
Address	35 Shinanomachi Shinjuku-Ku, Tokyo
TEL	03-5363-3971
Homepage URL
Email	yamagata@a6.keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Keio University
Address	35 Shinanomachi Shinjuku-Ku, Tokyo
Tel	03-5363-3503
Email	med-rinri-jimu@adst.keio.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	2019 Year 01 Month 10 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	2019 Year 01 Month 08 Day
Date of IRB	2019 Year 01 Month 20 Day
Anticipated trial start date	2019 Year 01 Month 22 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	2019 Year 01 Month 08 Day
Last modified on	2020 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040433