UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058144 |
|---|---|
| Receipt number | R000066452 |
| Scientific Title | Elucidation of the compensatory neural mechanisms for higher-order visuospatial dysfunction after damage to the central nervous system |
| Date of disclosure of the study information | 2025/06/10 |
| Last modified on | 2025/06/10 17:30:54 |
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Basic information
Public title
Elucidation of the compensatory mechanisms for impairments in visuospatial analogical reasoning after damage to the central nervous system
Acronym
The compensatory mechanisms for impairments in visuospatial analogical reasoning
Scientific Title
Elucidation of the compensatory neural mechanisms for higher-order visuospatial dysfunction after damage to the central nervous system
Scientific Title:Acronym
The compensatory neural mechanisms for higher-order visuospatial dysfunction
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the compensatory mechanisms for higher-order visuospatial dysfunction in patients with stroke.
Basic objectives2
Others
Basic objectives -Others
This study aims to investigate the causal role of specific brain regions of which functional connectivity may represent higher-order visuospatial function in compensation for impairments in the function after stroke.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Higher-order visuospatial function test score
Key secondary outcomes
Response time during tasks in higher-order visuospatial function test
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
We will perform transcranial magnetic stimulation of specific brain regions at random latency during tasks in the higher-order visuospatial function 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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria: are (1) healthy controls or (2) patients hospitalized or outpatients with stroke in our department, (3) those who can follow our instructions, (4) those who are able to keep sitting upright with backrest, and (5) those who are able to tolerate scans of magnetic resonance imaging (MRI) and behavioral tasks in the higher-order visuospatial function test.
Key exclusion criteria
Healthy controls: those who have a medical history of brain disease, neuromuscular disease, heart disease or seizure; those who have an implanted medical device incompatible with MRI (pacemaker, defibrillator, cochlear implant, deep brain/vagal nerve stimulator, magnetic clip, and dental magnetic implant, etc.); and pregnant woman. Stroke: those who do not meet the inclusion criteria and those who meet the exclusion criteria described in the section of healthy controls.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake 470-1192, Japan
TEL
0562-93-2167
otaka119@mac.com
Public contact
Name of contact person
| 1st name | Takamichi |
| Middle name | |
| Last name | Tohyama |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake 470-1192, Japan
TEL
0562-93-2167
Homepage URL
takamichi.tohyama@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
The Ethics Review Committee of Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake, Toyoake 470-1192, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2025 | Year | 06 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 10 | 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
Management information
Registered date
| 2025 | Year | 06 | Month | 10 | Day |
Last modified on
| 2025 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066452
