UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035489 |
|---|---|
| Receipt number | 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 | 2020/12/23 17:33:26 |
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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
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
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
yamagata@a6.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040433
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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