UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042334 |
|---|---|
| Receipt number | R000048327 |
| Scientific Title | Detection of electroencephalographic (EEG) activity expressing burning pain by the thermal grill illusion |
| Date of disclosure of the study information | 2020/11/04 |
| Last modified on | 2020/11/03 23:34:26 |
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Basic information
Public title
Detection of electroencephalographic (EEG) activity expressing burning pain by the thermal grill illusion
Acronym
Detection of electroencephalographic (EEG) activity expressing burning pain by the thermal grill illusion
Scientific Title
Detection of electroencephalographic (EEG) activity expressing burning pain by the thermal grill illusion
Scientific Title:Acronym
Detection of electroencephalographic (EEG) activity expressing burning pain by the thermal grill illusion
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We believe that examining EEG activity during burning pain induced by the thermal grill illusion, which has been reported to resemble central pain, will help elucidate the pathogenesis of central pain.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG is used as a physiological assessment to detect EEG activity associated with burning pain induced by the thermal grill illusion
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
EEG is used as a physiological assessment to detect the EEG activity associated with the burning pain induced by the thermal grill illusion.
Condition A. Subjects place their hands on a kit of four alternating warm (40) and four alternating cold (20) sticks and are asked to press a button to indicate when they feel a burning pain. Condition B. Place your hand on a kit of eight warm sticks only (40) and ask the subject to press a button to indicate when he or she feels warmth. In conditions A and B above, the EEG activity is extracted for 5 seconds after the button is pressed. The number of stimuli will be 20 trials for each condition, and pain and discomfort in each condition will be assessed using the Numerical Rating Scale (NRS 0 to 10). In addition, they will use the McGill Pain Questionnaire ver 2 to assess the nature of the pain.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Able-bodied individuals who have given their consent to the research plan
Key exclusion criteria
Those who cannot agree on a research plan
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Uragami |
| Middle name | |
| Last name | Shinji |
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
ptahodo0723@gmail.com
Public contact
Name of contact person
| 1st name | Uragami |
| Middle name | |
| Last name | Shinji |
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
0745541601
Homepage URL
ptahodo0723@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
ptahodo0723@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
| 2020 | Year | 11 | Month | 04 | 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
| 2020 | Year | 11 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 03 | Day |
Last modified on
| 2020 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048327
| 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 |
