UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045719 |
|---|---|
| Receipt number | R000052193 |
| Scientific Title | A study on the development of habituation-resistant brain function measurement method using dual process theory |
| Date of disclosure of the study information | 2021/10/15 |
| Last modified on | 2024/03/10 18:23:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on the development of habituation-resistant brain function measurement method using dual process theory
Acronym
A study on the development of habituation-resistant brain function measurement method using dual process theory
Scientific Title
A study on the development of habituation-resistant brain function measurement method using dual process theory
Scientific Title:Acronym
A study on the development of habituation-resistant brain function measurement method using dual process theory
Region
| Japan |
Condition
Condition
Healthy adult volunteer
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Decreased brain activity due to habituation, brought about by repeated measurement of cognitive tasks, is a major artifact in brain function tests.
Previous studies have shown that the Stroop task is resistant to habituation due to repeated measurements. However, the development of a test method that is resistant to habituation using cognitive tasks other than the Stroop task will help to ensure the diversity of tests.
The purpose of this study is to develop a method for testing brain functions that is resistant to habituation by using the dual process theory without using the Stroop task.
Translated with www.DeepL.com/Translator (free version)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Brain activity will be compared immediately after the test and one week after the test between brain function tests with and without dual process theory in the stimulus cognitive task.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
A method of testing brain function using cognitive tasks that do not include an emotional component as stimuli.
The test will be performed after 0 and 1 week.
Interventions/Control_2
A method of testing brain function using a cognitive task with a negative affective component as the stimulus.
The test will be performed after 0 and 1 week.
Interventions/Control_3
A method of testing brain function using cognitive tasks with a positive affective component as stimuli.
The test will be performed after 0 and 1 week.
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
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Undergraduate or graduate students in good health
Key exclusion criteria
People undergoing treatment for a diagnosis of anxiety disorder
People who are unable to give their consent to participate in the research
People who are experiencing significant psychological fatigue and have difficulty completing the task
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Senichiro |
| Middle name | Kikuchi |
| Last name | Kikuchi |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Rehabilitation Sciences
Zip code
3718514
Address
3-39-22 Showa-machi, Gunma, Japan
TEL
0272207111
senichiro@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Senichiro |
| Middle name | Kikuchi |
| Last name | Kikuchi |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Rehabilitation Sciences
Zip code
3718514
Address
3-39-22 Showa-machi, Gunma, Japan
TEL
0272207111
Homepage URL
senichiro@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Ministory of Education culture, sports, science and technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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, Gunma, Japan
Tel
0272207111
senichiro@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
群馬大学附属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
27
Results
A total of 27 healthy adults were tested. Negative stimuli tended to produce intrasessional habituation but with spontaneous recovery effects between intersessional tests, while neutral stimuli tended to produce more intersessional habituation. This indicates that the emotional stimuli accompanying the tests have some influence on the aspect of habituation.
Results date posted
| 2024 | Year | 03 | Month | 10 | 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
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 05 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 11 | Day |
Last modified on
| 2024 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052193
