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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041673
Receipt No. R000047566
Scientific Title Observational study to elucidate the mechanism of upper motor neuron involvement in motor neuron disease using threshold tracking transcranial magnetic stimulation and diffuse tenosr imaging, quantitative susceptibility mapping, and T1w/T2w ratio mapping
Date of disclosure of the study information 2020/09/15
Last modified on 2020/09/03

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Basic information
Public title Observational study to elucidate the mechanism of upper motor neuron involvement in motor neuron disease using threshold tracking transcranial magnetic stimulation and diffuse tenosr imaging, quantitative susceptibility mapping, and T1w/T2w ratio mapping
Acronym Observational study to elucidate the mechanism of upper motor neuron involvement in motor neuron disease using threshold tracking transcranial magnetic stimulation and diffuse tenosr imaging, quantitative susceptibility mapping, and T1w/T2w ratio mapping
Scientific Title Observational study to elucidate the mechanism of upper motor neuron involvement in motor neuron disease using threshold tracking transcranial magnetic stimulation and diffuse tenosr imaging, quantitative susceptibility mapping, and T1w/T2w ratio mapping
Scientific Title:Acronym Observational study to elucidate the mechanism of upper motor neuron involvement in motor neuron disease using threshold tracking transcranial magnetic stimulation and diffuse tenosr imaging, quantitative susceptibility mapping, and T1w/T2w ratio mapping
Region
Japan

Condition
Condition Motor neuron disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the correlation between SICI value of threshold tracking transcranial magnetic stimulation and parameter of upper motor involvement on brain MRI.
Basic objectives2 Others
Basic objectives -Others To assess the correlation between SICI value of threshold tracking transcranial magnetic stimulation and parameter of upper motor involvement on brain MRI.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between the SICI value and paramenter of upper motor neuron involvement on brain MRI
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Threshold tracking transcranial magnetic stimulation, Brain MRI, Neuropsychological test
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

Not applicable
Gender Male and Female
Key inclusion criteria 30 patients with motor neuron disease who visit the Chiba University Hospital.
30 healthy controls.
Key exclusion criteria People who are contraindicated for transcranial magnetic stimulation or brain MRI.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Sathoshi
Middle name
Last name Kuwabara
Organization Graduate School of Medicine, Chiba University
Division name Neurology
Zip code 260-8677
Address 1-8-1 Inohana Chuo-ku, Chiba
TEL +81-43-226-2129
Email kuwabara-s@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Atsuhiko
Middle name
Last name Sugiyama
Organization Graduate School of Medicine, Chiba University
Division name Neurology
Zip code 260-8677
Address 1-8-1 Inohana Chuo-ku, Chiba
TEL +81-43-226-2129
Homepage URL
Email asugiyama@chiba-u.jp

Sponsor
Institute Department of Neurology, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization The Nakabayashi Trust for ALS Research
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 Research ethics committee of the graduate school of medicine, Chiba university
Address 1-8-1 Inohana Chuo-ku, Chiba
Tel +81-43-222-7171
Email inohana-rinri@chiba-u.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
2020 Year 09 Month 15 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 Preinitiation
Date of protocol fixation
2020 Year 09 Month 03 Day
Date of IRB
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2022 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 09 Month 03 Day
Last modified on
2020 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047566

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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