UMIN-CTR Clinical Trial

Basic information
Public title	Prospective comparative study of resting-state brain functional networks between chronic pain patients and healthy patients
Acronym	A resting state fMRI study of chronic pain
Scientific Title	Prospective comparative study of resting-state brain functional networks between chronic pain patients and healthy patients
Scientific Title:Acronym	A resting state fMRI study of chronic pain
Region	Japan

Condition
Condition	Chronic pain
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It has been reported that the altered functional connectivity between brain regions may be associated in the development, prolongation, and augmentation of chronic pain. The objective of this prospective study is to detect the changes in functional connectivity of the brain regions associated with Default Mode Network (DMN) in chronic pain patients by using resting state fMRI. Further, we will examine the associations among the changes in functional connectivity, the intensity of chronic pain, and psychological indicators.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The changes in resting-state brain functional networks of chronic pain patients
Key secondary outcomes	1) Correlation between the changes in functional connectivity of brain networks and the intensity of pain 2) Correlation between the changes in functional connectivity of brain networks and psychological indicators (i.e. anxiety, depression, pain catastrophising, consistency, insomnia, impulsivity). 3) Correlation between the DMN and other brain networks in chronic pain patients

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
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Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Chronic pain patients group: 20-75 years old, right handed, and patients whose pain has been persisting for more than 3 month. Healthy control group: Healthy volunteer who were age-matched
Key exclusion criteria	Brain structural abnormality Contraindication to MRI Patients who cannot keep supine position during MRI Patients who are medicated for epilepsy and depression
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shizuko Kosugi
Organization	Keio University School of Medicine
Division name	Depertment of Anesthesiology
Zip code
Address	35 Shinanomachi Shinjukuku Tokyo Japan
TEL	03-5363-3107
Email	shizuko.kosugi@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Naho Ihara
Organization	Keio University School of Medicine
Division name	Depertment of Anesthesiology
Zip code
Address	35 Shinanomachi Shinjukuku Tokyo Japan
TEL	03-5363-3107
Homepage URL
Email	naho.ihara@keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio University of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
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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	2016 Year 11 Month 01 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
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Results Delayed
Results Delay Reason
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
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IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 17 Day
Date of IRB	2016 Year 10 Month 17 Day
Anticipated trial start date	2016 Year 10 Month 17 Day
Last follow-up date	2019 Year 08 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The objective of this prospective study is to detect the changes in functional connectivity of the brain regions associated with Default Mode Network (DMN) in chronic pain patients by using resting state fMRI.

Management information
Registered date	2016 Year 10 Month 19 Day
Last modified on	2019 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028171