UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054958 |
|---|---|
| Receipt number | R000062796 |
| Scientific Title | Rehabilitation intervention for motor paralysis after stroke and the significance of changes in brain function. |
| Date of disclosure of the study information | 2024/07/20 |
| Last modified on | 2024/07/13 21:41:40 |
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Basic information
Public title
Rehabilitation intervention for motor paralysis after stroke and the significance of changes in brain function.
Acronym
Rehabilitation intervention for motor paralysis after stroke and changes in brain function.
Scientific Title
Rehabilitation intervention for motor paralysis after stroke and the significance of changes in brain function.
Scientific Title:Acronym
Rehabilitation intervention for motor paralysis after stroke and changes in brain function.
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the mechanisms of changes in brain function and structure during NEURO and to examine whether NEURO has clinical utility for stroke-induced hemiplegia patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The analysis result from Magnetic Resonance Imaging data
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients must be hospitalized for 15 days. After hospitalization, individual rehabilitation focusing on the upper limbs is performed with daily magnetic stimulation therapy.
Interventions/Control_2
No NEURO treatment, only rehabilitation
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet the indication criteria for NEURO and who can undergo MRI before and after NEURO
Key exclusion criteria
Patients who are unable to fully understand the purpose of the study due to cognitive impairments, including comprehension
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Atushi |
| Middle name | |
| Last name | senoo |
Organization
Tokyo Metropolitan University
Division name
Department of Radiology, Graduate School of Human Health Sciences
Zip code
116-8551
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL
03-3819-1211
senoo@tmu.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Senoo |
Organization
Tokyo Metropolitan University
Division name
Department of Radiology, Graduate School of Human Health Sciences
Zip code
116-8551
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL
03-3819-1211
Homepage URL
enoo@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan University Arakawa campus Institutional Review Board
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
Tel
03-3819-1211
rinri-hs@tmu.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
いずみ記念病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 20 | 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 | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 02 | 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 | 07 | Month | 13 | Day |
Last modified on
| 2024 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062796
