UMIN-CTR Clinical Trial

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