UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024475 |
|---|---|
| Receipt number | R000028171 |
| Scientific Title | Prospective comparative study of resting-state brain functional networks between chronic pain patients and healthy patients |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2019/08/30 19:00:37 |
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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
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
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
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
naho.ihara@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 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
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028171
