UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045113 |
|---|---|
| Receipt number | R000051537 |
| Scientific Title | Neuroimaging of ME/CFS |
| Date of disclosure of the study information | 2021/08/10 |
| Last modified on | 2021/11/26 17:07:35 |
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Basic information
Public title
Neuroimaging of ME/CFS
Acronym
PET_ME
Scientific Title
Neuroimaging of ME/CFS
Scientific Title:Acronym
PET_ME
Region
| Japan |
Condition
Condition
ME/CFS and long COVID
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate neuroinflammation of long COVID and ME/CFS using PET imaging
Basic objectives2
Others
Basic objectives -Others
Feasibility of PET imaging
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distribution and quantification of neuroinflammation evaluated by PET imaging
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ME/CFS patients meeting Canadian criteria
Long COVID patients with long-lasting brain fog significantly affecting daily/social life
Key exclusion criteria
Malignancy
Pregnancy
Active infection
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | Sato |
| Last name | Yamamura |
Organization
National Center of Neurology and Psychiatry
Division name
Institute of neuroscience
Zip code
1878501
Address
Ogawa-higashi, Kodaira, Tokyo, JAPAN
TEL
042-341-2711
yamamura@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Wakiro |
| Middle name | Sato |
| Last name | Sato |
Organization
National Institute of Neuroscience, National Center of Neurology and Psychiatry
Division name
Department of immunology
Zip code
187-8502
Address
Ogawahigashi, Kodaira, Tokyo
TEL
0423412711
Homepage URL
satow@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NCNP ethics comittee
Address
4-1-1, Ogawahigashi, Kodaira, Tokyo, JAPAN
Tel
0423412711
ml_rinrijimu@ncnp.go.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
PET imaging with various cognitive assessment
Management information
Registered date
| 2021 | Year | 08 | Month | 10 | Day |
Last modified on
| 2021 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051537
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
