UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040870 |
|---|---|
| Receipt number | R000046659 |
| Scientific Title | Research on objective evaluation method of neurological symptoms in Minamata disease using MEG and MRI |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2021/12/24 10:43:31 |
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Basic information
Public title
Research on objective evaluation method of neurological symptoms in Minamata disease
Acronym
Clinical study of Minamata disease
Scientific Title
Research on objective evaluation method of neurological symptoms in Minamata disease using MEG and MRI
Scientific Title:Acronym
Clinical study of Minamata disease
Region
| Japan |
Condition
Condition
Minamata Disease
Classification by specialty
| Neurology | Radiology | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of objective evaluation method of Minamata disease neurological symptoms
Basic objectives2
Others
Basic objectives -Others
To elucidate the influence of methylmercury on brain function using MEG and MRI
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Somatosensory evoked magnetic fields
Brain volume
Running of the nerve fiber in the brain white matter
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Somatosensory evoked magnetic fields
Brain volume
Running of the nerve fiber in the brain white matter
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults and certified Minamata desease patients
Key exclusion criteria
Person who corresponds to MRI examination contraindication
Target sample size
310
Research contact person
Name of lead principal investigator
| 1st name | Nakamura |
| Middle name | |
| Last name | Masaaki |
Organization
National Institute for Minamata Disease
Division name
Department of Clinical Medicine
Zip code
867-0008
Address
4058-18,Hama,Minamata,Kumamoto,867-0008
TEL
0966-63-3111
MASAAKI_NAKAMURA@env.go.jp
Public contact
Name of contact person
| 1st name | Nakamura |
| Middle name | |
| Last name | Masaaki |
Organization
National Institute for Minamata Disease
Division name
Department of Clinical Medicine
Zip code
867-0008
Address
4058-18,Hama,Minamata,Kumamoto,867-0008
TEL
0966-63-3111
Homepage URL
MASAAKI_NAKAMURA@env.go.jp
Sponsor or person
Institute
National Institute for Minamata Disease
Institute
Department
Personal name
Funding Source
Organization
Ministry of the Environment
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
Institutional Review Board in National Institute for Minamata Disease
Address
4058-18, Hama, Minamata, Kumamoto, 867-0008
Tel
0966-63-3111
MASAAKI_NAKAMURA@env.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
国保水俣市立総合医療センターに設置したメグセンター（熊本県）（MEG Center in Minamata City General Hospital & Medical Center）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 23 | Day |
Last modified on
| 2021 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046659
| Research Plan | |
|---|---|
| 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 |
