UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041673 |
|---|---|
| Receipt number | 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 | 2024/03/07 16:24:49 |
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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
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
asugiyama@chiba-u.jp
Sponsor or person
Institute
Department of Neurology, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
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
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 09 | Month | 03 | Day |
Last modified on
| 2024 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047566
| 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 |
