UMIN-CTR Clinical Trial

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