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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035489
Receipt No. R000040433
Scientific Title Effectiveness of near-infrared spectroscopy neurofeedback for psychiatric disorders
Date of disclosure of the study information 2019/01/10
Last modified on 2019/01/08

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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
Last name of lead principal investigator
1st name
Middle name
Last name Bun Yamagata
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi Shinjuku-Ku, Tokyo
TEL 03-3353-1211
Email yamagata@a6.keio.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Bun Yamagata
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi Shinjuku-Ku, Tokyo
TEL 03-3353-1211
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
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
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 Preinitiation
Date of protocol fixation
2019 Year 01 Month 08 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 10 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
2019 Year 01 Month 08 Day
Last modified on
2019 Year 01 Month 08 Day


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

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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