UMIN-CTR Clinical Trial

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
Email	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
Email	MASAAKI_NAKAMURA@env.go.jp

Sponsor
Institute	National Institute for Minamata Disease
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046659