UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035966 |
|---|---|
| Receipt number | 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 | 2020/08/24 10:54:02 |
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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
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
n-tani@med.kyushu-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical Sciences
Kyushu University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2019 | Year | 02 | Month | 21 | Day |
Last modified on
| 2020 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040961
