UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052458 |
|---|---|
| Receipt number | R000059878 |
| Scientific Title | Clarification of pathophysiology of motor neuron disease using neuronal excitability testing and MR Spectroscopy |
| Date of disclosure of the study information | 2023/10/11 |
| Last modified on | 2023/10/10 18:30:02 |
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Basic information
Public title
Clarification of pathophysiology of motor neuron disease using neuronal excitability testing and MR Spectroscopy
Acronym
Clarification of pathophysiology of motor neuron disease using neuronal excitability testing and MR Spectroscopy
Scientific Title
Clarification of pathophysiology of motor neuron disease using neuronal excitability testing and MR Spectroscopy
Scientific Title:Acronym
Clarification of pathophysiology of motor neuron disease using neuronal excitability testing and MR Spectroscopy
Region
| Japan |
Condition
Condition
Motor neuron disease and those possible patients
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarification of pathophysiology of motor neuron disease
Basic objectives2
Others
Basic objectives -Others
Alteration of neuronal excitability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Result of neuronal excitability testing and MR Spectroscopy
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Neuronal excitability testing and MR Spectroscopy
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Over 18 year old
2) Amyotrophic lateral sclerosis and those possible patients
3) Obtainment of informed consent from patients
Key exclusion criteria
1) Patients with implement provided with a metallic portion or epilepsy, who are contraindication for transcranial magnetic stimulation
2) Patients who are contraindication for MRI
3) Patients who are judged, as inappropriate for testing, by principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kuwabara |
| Middle name | |
| Last name | Satoshi |
Organization
Chiba University
Division name
Department of Neurology
Zip code
260-8677
Address
1-8-1 Inohana Chuo-ku, Chiba
TEL
043-226-2129
kuwabara-s@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Shibuya |
| Middle name | |
| Last name | Kazumoto |
Organization
Chiba University
Division name
Department of Neurology
Zip code
260-8677
Address
1-8-1 Inohana Chuo-ku, Chiba
TEL
043-226-2129
Homepage URL
kazumoto@net.email.ne.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Chiba University Hospital
Address
1-8-1 Inohana Chuo-ku, Chiba
Tel
043-222-7171
hsp-kansaturinri@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
| 2023 | Year | 10 | Month | 11 | 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
| 2023 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 10 | Day |
Last modified on
| 2023 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059878
| 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 |
