UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060629 |
|---|---|
| Receipt number | R000069343 |
| Scientific Title | The relationship between stimulus danger and attentional effects |
| Date of disclosure of the study information | 2026/02/09 |
| Last modified on | 2026/02/09 16:44:10 |
* 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
The relationship between stimulus danger and attentional effects
Acronym
The relationship between stimulus danger and attentional effects
Scientific Title
The relationship between stimulus danger and attentional effects
Scientific Title:Acronym
The relationship between stimulus danger and attentional effects
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Even after injury healing, athletes may experience persistent pain and be forced to withdraw from training for extended periods. We hypothesize that one of the causes of this is an overactive attentional function resulting from injury.
It has been reported that paying attention to noxious stimuli increases subjective pain and neural activity. However, there is evidence that attention to weak stimuli does not increase neural activity in the somatosensory cortex. This is thought to be because attention in the somatosensory cortex suppresses safe information and enhances only dangerous information. Therefore, we hypothesize that chronic pain in athletes that persists after injury healing may be caused by a breakdown in attentional function, resulting in excessive attention to mild stimuli that would not normally be perceived as painful. Therefore, this study aimed to examine the relationship between normal attentional function and neural activity in healthy individuals, providing baseline data for future research into athletes with chronic pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In this study, healthy athletes were presented with noxious thermal stimuli and non-noxious electrical stimuli, and neural activity was measured using electroencephalography (EEG).
In addition, the relationship to subjective pain was assessed using a visual analog scale (VAS).
This will provide baseline data on the relationship between normal attentional function and neural activity in healthy individuals. The findings are expected to provide a foundation for future interpretation of the relationship between attentional function and neural activity in athletes with chronic pain.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Thermal stimulation
Cold stimulation
Electrical stimulation
Electroencephalogram
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
| 18 | years-old | <= |
Age-upper limit
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy male and female athletes without pain lasting more than 3 months
Right-handed
No history of mental illness or neurological disorders
Key exclusion criteria
Individuals experiencing pain lasting three months or longer
Left-handed individuals
Individuals with a history of mental or neurological disorders
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Moka |
| Middle name | |
| Last name | Hoshiba |
Organization
Niigata University of Health and Welfare Graduate School
Division name
Health Science Major, Health and Sports Science Field
Zip code
950-3198
Address
1398 Shimami-cho, Kita Ward, Niigata City, Niigata Prefecture
TEL
025-257-4455
wtm25012@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Kouya |
| Middle name | |
| Last name | Yamashiro |
Organization
Niigata University of Health and Welfare
Division name
Health and Sports Department
Zip code
950-3198
Address
1398 Shimami-cho, Kita Ward, Niigata City, Niigata Prefecture
TEL
025-257-4757
Homepage URL
yamashiro@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
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
1398 Shimami-cho, Kita Ward, Niigata City, Niigata Prefecture
Tel
025-257-4455
wtm25012@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
| 2026 | Year | 02 | Month | 09 | 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
| 2026 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 10 | 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
| 2026 | Year | 02 | Month | 09 | Day |
Last modified on
| 2026 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069343
