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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042334
Receipt No. 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

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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
Email 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
Email ptahodo0723@gmail.com

Sponsor
Institute kio university
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048327

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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