UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038001 |
|---|---|
| Receipt number | 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 | 2022/03/15 09:46:04 |
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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
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
senichiro@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
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
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
24
Results
The letter Stroop task showed neither habituation nor spontaneous recovery, indicating that it continues to be a strong habituation task.
In the animal Stroop task, habituation was observed, but spontaneous recovery was also observed.
Therefore, it is suggested that the animal Stroop task is also a task that is resistant to habituation by repeated measurements, provided that the test interval of about 4 weeks is provided, which is necessary for spontaneous recovery.
Results date posted
| 2021 | Year | 10 | Month | 11 | Day |
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
Completed
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
Recruitment was closed because sufficient numbers were gathered for analysis.
Management information
Registered date
| 2019 | Year | 09 | Month | 12 | Day |
Last modified on
| 2022 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043321
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
