UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053182 |
|---|---|
| Receipt number | R000060642 |
| Scientific Title | Effects of experimental pain and clinical on spatial attention |
| Date of disclosure of the study information | 2023/12/21 |
| Last modified on | 2023/12/20 17:08:25 |
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Basic information
Public title
Effects of experimental pain and clinical on spatial attention
Acronym
Effects of experimental pain and clinical on spatial attention
Scientific Title
Effects of experimental pain and clinical on spatial attention
Scientific Title:Acronym
Effects of experimental pain and clinical on spatial attention
Region
| Japan |
Condition
Condition
healthy person
patients with clinical pain in acute phase
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of experimental hyperalgesia on spatial attention function.
To conduct a comparative study of the experimental results of patients with acute pain and healthy controls.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG is used for physiologic assessment to detect EEG activity related to pain-induced attentional function.
In healthy participants, temporal order judgement will be performed on the group that causes secondary hyperalgesia to the right hand and the group that causes hyperalgesia to the left hand, and spatial attention functions will be performed.
Key secondary outcomes
EEG is used for physiologic assessment to detect EEG activity related to pain-induced attentional function.
In patients with clinical pain in acute phase, temporal order judgement will be performed, and spatial attention functions will be performed.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
EEG is used for physiologic assessment to detect EEG activity related to pain-induced attentional function.
In healthy participants, temporal order judgement will be performed on the group that causes secondary hyperalgesia to the right hand and the group that causes hyperalgesia to the left hand, and spatial attention functions will be performed.
Interventions/Control_2
EEG is used for physiologic assessment to detect EEG activity related to pain-induced attentional function.
In patients with clinical pain in acute phase, temporal order judgement will be performed, and spatial attention functions will be performed.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy person
patients with clinical pain in acute phase
Key exclusion criteria
Persons with complications of sensory disorders originating from peripheral nerves, such as diabetes mellitus, or from spinal nerve roots, such as spinal canal stenosis.
Patients with aphasia who cannot understand the research or the explanation of the assignment.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Morikawa |
Organization
Kio University
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2, Umaminaka, Hiroyo-cho, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
yuki.morikawa.89@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Morikawa |
Organization
Kio University
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2, Umaminaka, Hiroyo-cho, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
Homepage URL
yuki.morikawa.89@gmail.com
Sponsor or person
Institute
kio university
Institute
Department
Personal name
Funding Source
Organization
kio university
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
kio university
Address
4-2-2, Umaminaka, Hiroyo-cho, Kitakatsuragi-gun, Nara
Tel
0745-54-1601
yuki.morikawa.89@gmail.com
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
| 2023 | Year | 12 | Month | 21 | 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
| 2023 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 20 | Day |
Last modified on
| 2023 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060642
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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