UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055626 |
|---|---|
| Receipt number | R000063568 |
| Scientific Title | Elucidation of the neural circuits in amyotrophic lateral sclerosis (ALS) using fMRI |
| Date of disclosure of the study information | 2024/09/26 |
| Last modified on | 2024/09/30 17:06:33 |
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Basic information
Public title
Elucidation of the neural circuits in amyotrophic lateral sclerosis (ALS) using fMRI
Acronym
Elucidation of the neural circuits in amyotrophic lateral sclerosis (ALS) using fMRI
Scientific Title
Elucidation of the neural circuits in amyotrophic lateral sclerosis (ALS) using fMRI
Scientific Title:Acronym
Elucidation of the neural circuits in amyotrophic lateral sclerosis (ALS) using fMRI
Region
| Japan |
Condition
Condition
Amyotrophic Lateral Sclerosis
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate the mechanism of motor neuron circuit impairment in ALS patients using layer fMRI technology.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fMRI images
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Evaluating brain activity during hand motion experiments using fMRI
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ALS patients are being treated at the Department of Neurology, Okayama University Hospital.
Key exclusion criteria
People who cannot get into the MRI scanner.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Jiajia |
| Middle name | |
| Last name | Yang |
Organization
Okayama University
Division name
Interdisciplinary Science and Engineering in Health Systems
Zip code
700-8530
Address
3-1-1 Tsushima-Naka, Kita-ku, Okayama
TEL
086-251-8053
yang@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Jiajia |
| Middle name | |
| Last name | Yang |
Organization
Okayama University
Division name
Interdisciplinary Science and Engineering in Health Systems
Zip code
700-8530
Address
3-1-1 Tsushima-Naka, Kita-ku, Okayama
TEL
086-251-8053
Homepage URL
yang@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Sceince
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
Okayama University
Address
3-1-1 Tsushima-Naka, Kita-ku, Okayama
Tel
086-251-8919
tsushima-rinri@adm.okayama-u.ac.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
| 2024 | Year | 09 | Month | 26 | 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
| 2024 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2029 | 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
| 2024 | Year | 09 | Month | 26 | Day |
Last modified on
| 2024 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063568
