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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038001
Receipt No. R000043321
Scientific Title Study on habituation and spontaneous recovery of the cerebral activity by using wearable NIRS
Date of disclosure of the study information 2019/12/01
Last modified on 2019/09/12

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Basic information
Public title Study on habituation and spontaneous recovery of the cerebral activity by using wearable NIRS
Acronym Study on habituation and spontaneous recovery of the cerebral activity by using wearable NIRS
Scientific Title Study on habituation and spontaneous recovery of the cerebral activity by using wearable NIRS
Scientific Title:Acronym Study on habituation and spontaneous recovery of the cerebral activity by using wearable NIRS
Region
Japan

Condition
Condition Person who has psychiatric problems and undergoes psychiatric rehabilitation
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To find the neurocognitive task which has strong spontaneous recovery after habituation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of the oxyhemoglobin in the week 0, week 1, and week 5
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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 The participants undergo three neurocognitive tasks for three times over six weeks, in which the cerebral activity is examined.
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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria Healthy student volunteers
Key exclusion criteria Person who has experienced the previous NIRS study in this facilitation
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Senichiro
Middle name
Last name Kikuchi
Organization Gunma University, Faculty of Medicine School of Health Sciences
Division name Department of Rehabilitation
Zip code 371-8514
Address 3-39-22, Showa-machi, Maebashi city, Gunma-pref.
TEL 027-220-8939
Email senichiro@gunma-u.ac.jp

Public contact
Name of contact person
1st name Senichiro
Middle name
Last name Kikuchi
Organization Gunma University, Faculty of Medicine School of Health Sciences
Division name Department of Rehabilitation
Zip code 371-8514
Address 3-39-22, Showa-machi, Maebashi city, Gunma-pref.
TEL 027-220-8939
Homepage URL
Email senichiro@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Gunma University
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 Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address 3-39-22, Showa-machi, Maebashi city, Gunma-pref.
Tel 027-220-8740
Email hitotaisho-ciru@ml.gunma-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
2019 Year 12 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
2019 Year 09 Month 09 Day
Date of IRB
2019 Year 09 Month 09 Day
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2022 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 09 Month 12 Day
Last modified on
2019 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043321

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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