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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035966
Receipt No. R000040961
Scientific Title A spatiotemporal processing of pain and its modulation by the cognitive information using movies: An MEG study
Date of disclosure of the study information 2019/02/27
Last modified on 2019/02/27

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Basic information
Public title A spatiotemporal processing of pain and its modulation by the cognitive information using movies: An MEG study
Acronym A spatiotemporal processing of pain and its modulation by the cognitive information using movies: An MEG study
Scientific Title A spatiotemporal processing of pain and its modulation by the cognitive information using movies: An MEG study
Scientific Title:Acronym A spatiotemporal processing of pain and its modulation by the cognitive information using movies: An MEG study
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Pain is a crucial problem for human life. Pain perception is caused by the integration between sensory and contextual, e.g. cognitive and affective, information in the brain. Here, we aim to reveal a spatiotemporal activation of pain processing in the brain and its modulation by the cognitive information, using magnetoencephalography (MEG) keeping with high spatial and temporal resolution.
Basic objectives2 Others
Basic objectives -Others Exploratory research
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The amplitude and the brain regions by using cortical currents estimated from MEG.
Key secondary outcomes visual analog scale.

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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 pain and tactile stimulation
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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria 1. A healthy person with right-handed
2. Consent to participate in the study
Key exclusion criteria 1. Past history of psychiatric or neurological disorder, chronic pain,
2. A person who has a contraindication to undergoing MRI
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shozo Tobimatsu
Organization Graduate School of Medical Sciences
Kyushu University
Division name Department of Clinical Neurophysiology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka-city, JAPAN
TEL 092-642-5543
Email tobi@neurophy.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nami Taniguchi
Organization Graduate School of Medical Sciences Kyushu University
Division name Department of Clinical Neurophysiology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka-city, JAPAN
TEL 092-642-5543
Homepage URL
Email n-tani@med.kyushu-u.ac.jp

Sponsor
Institute Graduate School of Medical Sciences
Kyushu University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 02 Month 27 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
2019 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 21 Day
Last modified on
2019 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040961

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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