UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062262 |
|---|---|
| Receipt number | R000071248 |
| Scientific Title | Neurophysiological Markers of Post-Stroke Fatigue in Convalescent Stroke Patients: A Resting-State EEG and CPT-AX NIRS Study |
| Date of disclosure of the study information | 2026/07/17 |
| Last modified on | 2026/07/17 01:56:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Neurophysiological Markers of Post-Stroke Fatigue in Convalescent Stroke Patients: A Resting-State EEG and CPT-AX NIRS Study
Acronym
Neurophysiological Markers of Post-Stroke Fatigue in Convalescent Stroke Patients: A Resting-State EEG and CPT-AX NIRS Study
Scientific Title
Neurophysiological Markers of Post-Stroke Fatigue in Convalescent Stroke Patients: A Resting-State EEG and CPT-AX NIRS Study
Scientific Title:Acronym
Neurophysiological Markers of Post-Stroke Fatigue in Convalescent Stroke Patients: A Resting-State EEG and CPT-AX NIRS Study
Region
| Japan |
Condition
Condition
healthy person
patients with post stroke fatigue
patients without post stroke fatigue
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the neurophysiological mechanisms of post-stroke fatigue (PSF) and identify objective biomarkers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resting-state EEG will be used to assess baseline brain activity and functional connectivity associated with post-stroke fatigue (PSF).
NIRS during the CPT will be used to evaluate prefrontal cortical activity during sustained attention and the process of fatigue development.
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
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
For participants with post-stroke fatigue, resting-state EEG will be recorded as a physiological assessment. NIRS measurements will also be performed during the CPT-AX task. Subjective fatigue will be assessed using a visual analog scale (VAS) before and after the task, and fatigue severity will be evaluated using the MFI-20 before the task.
Interventions/Control_2
For participants without post-stroke fatigue, resting-state EEG will be recorded as a physiological assessment. NIRS measurements will also be performed during the CPT-AX task. Subjective fatigue will be assessed using a visual analog scale (VAS) before and after the task, and fatigue severity will be evaluated using the MFI-20 before the task.
Interventions/Control_3
For healthy controls, NIRS measurements will be performed during the CPT-AX task. Subjective fatigue will be assessed using a visual analog scale (VAS) before and after the task, and fatigue severity will be evaluated using the MFI-20 before the task.
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
Healthy controls
Stroke patients with post-stroke fatigue
Stroke patients without post-stroke fatigue
Key exclusion criteria
Persons who cannot understand the research or the explanation of the assignment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Risa |
| Middle name | |
| Last name | Yoshikawa |
Organization
Kio University
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2, Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
mrokyskw.st@gmail.com
Public contact
Name of contact person
| 1st name | Risa |
| Middle name | |
| Last name | Yoshikawa |
Organization
Kio University
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2, Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
Homepage URL
mrokyskw.st@gmail.com
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
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
Kio University
Address
4-2-2, Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
Tel
0745-54-1601
mrokyskw.st@gmail.com
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 | 07 | Month | 17 | 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 | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2029 | Year | 03 | 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
| 2026 | Year | 07 | Month | 17 | Day |
Last modified on
| 2026 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071248
