UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045556 |
|---|---|
| Receipt number | R000052011 |
| Scientific Title | Sensory modality change alters response inhibitory control |
| Date of disclosure of the study information | 2021/09/24 |
| Last modified on | 2024/05/31 08:28:30 |
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Basic information
Public title
Sensory modality change alters response inhibitory control
Acronym
Sensory modality change alters response inhibitory control
Scientific Title
Sensory modality change alters response inhibitory control
Scientific Title:Acronym
Sensory modality change and response inhibitory control
Region
| Japan |
Condition
Condition
healthy persons
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to provide direct evidence that modality change alters response inhibition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
response inhibition function and associated neural activity
Key secondary outcomes
name, age, sex, height, weight, medical history, menstrual cycle (female only)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
visual stimuli (LED)
Interventions/Control_2
somatosensory stimuli (electrical stimulation, 2.5 times sensory threshold)
Interventions/Control_3
auditory stimuli(1000 or 1500Hz/80db)
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
| 18 | years-old | < |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy people who are interested in this research and who voluntarily apply to participate in response to an open call.
Key exclusion criteria
Neurological and psychiatric illness and history of such illnesses
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Sato |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports
Zip code
950-3198
Address
Shimami-cho 1398, Kita-ku, Niigata city
TEL
025-257-4624
daisuke@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Sato |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports
Zip code
950-3198
Address
Shimami-cho 1398, Kita-ku, Niigata city
TEL
025-257-4624
Homepage URL
daisuke@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Society for The Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
Shimami-cho 1398, Kita-ku, Niigata city
Tel
025-257-4624
daisuke@nuhw.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
| 2021 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
DOI: 10.3390/brainsci12111530
Publication of results
Published
Result
URL related to results and publications
DOI: 10.3390/brainsci12111530
Number of participants that the trial has enrolled
21
Results
The response inhibition function (action postponing and action restraint) and its neural activity by visual, auditory and somatosensory modalities were examined. The results showed that visual response restraint function was highest.
Results date posted
| 2024 | Year | 05 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy male and female
Participant flow
Recuitment
Adverse events
None
Outcome measures
inhibitory function and event related potentials
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 09 | Month | 24 | Day |
Last modified on
| 2024 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052011
