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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040403
Receipt No. R000046101
Scientific Title Investigation of disease-specific neuroimaging profiles of chronic pain using microglia PET and multimodal MRI
Date of disclosure of the study information 2020/05/14
Last modified on 2020/05/14

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Basic information
Public title Brain science of chronic pain using PET and MRI
Acronym Neuroimaging of chronic pain
Scientific Title Investigation of disease-specific neuroimaging profiles of chronic pain using microglia PET and multimodal MRI
Scientific Title:Acronym Microglia PET/MRI study in chronic pain
Region
Japan

Condition
Condition fibromyalgia, chronic low back pain, postherpetic neuralgia, other chronic pain disorders
Classification by specialty
Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine cerebral pathophysiological changes in chronic pain using PET imaigng of microglia activation and multimodal MRI of brain anatomy and function.
Basic objectives2 Others
Basic objectives -Others Correlation analysis among multimodal imaging and psychophysical parameters.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intensity and distribution of microglia activation, as well as functional/anatomical activation/connectivity, in the brain of chronic pain patients in comparison with healthy controls.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Patients with chronic pain at a pain score >= 3/10 lasting >= 3 months (fibromyalgia, n = 15; chronic low back pain, 15; postherpetic neuralgia, 15; other chronic pain disorders, 15; healthy controls, 20)
Key exclusion criteria Any person with in-body metals or electrical devices; tattoo; pregnancy; claustrophobia; or neurocognitive or consciousness disorder preventing informed consent
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Jiro
Middle name
Last name Kurata
Organization Jikei University
Division name Department of Anesthesiology
Zip code 105-8461
Address 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Email jkurata@plum.plala.or.jp

Public contact
Name of contact person
1st name Jiro
Middle name
Last name Kurata
Organization The Jikei University School of Medicine
Division name Department of Anesthesiology
Zip code 105-8461
Address 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Homepage URL
Email jkurata@plum.plala.or.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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 The Ethics committee of The Jikei University School of Medicine for Biomedical Research
Address 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo
Tel 03-3433-1111
Email rinri@jikei.ac.jp

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 東京慈恵会医科大学(東京都)、浜松医科大学(静岡県)

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 14 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 05 Month 11 Day
Date of IRB
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The current study is a cross-sectional observational study performing correlational analyses among PET, MRI and psychophysical/behavioral parameters.

Management information
Registered date
2020 Year 05 Month 14 Day
Last modified on
2020 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046101

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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