UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061622 |
|---|---|
| Receipt number | R000070502 |
| Scientific Title | Relationship between motor cortical excitatory and inhibitory dynamics during muscle contraction and relaxation and the corticospinal tract in patients with stroke: An EEG ERD/ERS and MRI structural analysis study |
| Date of disclosure of the study information | 2026/05/20 |
| Last modified on | 2026/05/19 00:25:17 |
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Basic information
Public title
Relationship between brain activity and neural pathways during muscle contraction and relaxation in patients with stroke
Acronym
Stroke Study
Scientific Title
Relationship between motor cortical excitatory and inhibitory dynamics during muscle contraction and relaxation and the corticospinal tract in patients with stroke: An EEG ERD/ERS and MRI structural analysis study
Scientific Title:Acronym
EEG Study in Patients with Stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between the corticospinal tract and the central neural mechanisms underlying muscle contraction relaxation impairments associated with corticospinal tract damage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Event-related desynchronization (ERD) and event-related synchronization (ERS) of EEG will be measured within 1-6 months after stroke onset.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with first-ever stroke and unilateral lesions admitted to the convalescent rehabilitation ward of Inokuchi Hospital.
Key exclusion criteria
Patients with a history of orthopedic disorders affecting upper limb movement or neurological disorders other than cerebrovascular disease, those with cerebellar ataxia, those with severe cognitive impairment, those with a history of psychiatric disorders, those with scalp conditions interfering with EEG measurement, those who declined participation in the study, those who were transferred to another hospital or died due to acute exacerbation, and those who developed a new stroke during the study period.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | matsuura |
| Middle name | |
| Last name | akihiro |
Organization
Hiroshima International University
Division name
Department of Rehabilitation, Graduate School of Medical Sciences
Zip code
739--2631
Address
555-36 Kurose Gakuendai, Higashihiroshima City, Hiroshima Prefecture
TEL
0823-70-4914
matsuura@hirokoku-u.ac.jp
Public contact
Name of contact person
| 1st name | matsuura |
| Middle name | |
| Last name | akihiro |
Organization
Hiroshima International University
Division name
Department of Rehabilitation, Graduate School of Medical Sciences
Zip code
739--2631
Address
555-36 Kurose Gakuendai, Higashihiroshima City, Hiroshima Prefecture
TEL
0823-70-4914
Homepage URL
matsuura@hirokoku-u.ac.jp
Sponsor or person
Institute
Hiroshima International University
Institute
Department
Personal name
Funding Source
Organization
none
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
Hiroshima International University
Address
555-36 Kurose Gakuendai, Higashihiroshima City, Hiroshima Prefecture
Tel
0823-69-6083
HIU.Kenkyu@josho.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
| 2026 | Year | 05 | 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
| 2026 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measurement items: electroencephalography (EEG), electromyography (EMG), and magnetic resonance imaging (MRI)
Management information
Registered date
| 2026 | Year | 05 | Month | 19 | Day |
Last modified on
| 2026 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070502
