UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059927 |
|---|---|
| Receipt number | R000068539 |
| Scientific Title | Changes in Cerebral Blood Flow During Swallowing and Dual-Task Conditions Using Near-Infrared Spectroscopy: A Study in Healthy Subjects |
| Date of disclosure of the study information | 2025/11/30 |
| Last modified on | 2025/11/30 10:57:18 |
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Basic information
Public title
Changes in Cerebral Blood Flow During Swallowing and Dual-Task Conditions Using Near-Infrared Spectroscopy: A Study in Healthy Subjects
Acronym
Changes in Cerebral Blood Flow During Swallowing and Dual-Task Conditions Using Near-Infrared Spectroscopy
Scientific Title
Changes in Cerebral Blood Flow During Swallowing and Dual-Task Conditions Using Near-Infrared Spectroscopy: A Study in Healthy Subjects
Scientific Title:Acronym
Changes in Cerebral Blood Flow During Swallowing and Dual-Task Conditions Using Near-Infrared Spectroscopy
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study employs functional near-infrared spectroscopy (fNIRS) to identify the higher-level cortical regions driving the masticatory center during swallowing.
Furthermore, it analyzes cortical responses during dual-task training involving simultaneous motor and cognitive tasks.
The objective is to demonstrate the efficacy of dual-task training in enhancing swallowing function using clinical indicators and cerebral blood flow dynamics assessment, thereby establishing an effective approach for dysphagia in dementia patients. As a preliminary experiment, we will use functional near-infrared spectroscopy (fNIRS) in healthy subjects to identify brain regions involved in performing dual tasks.
Translated with DeepL.com (free version)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in cerebral blood flow between resting and task states
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults aged 20 to 65 years
Individuals without serious chronic diseases (diabetes, hypertension, heart disease, kidney disease, etc.)
Individuals in good oral and general health (as determined by the principal investigator or self-report)
Individuals who understand the purpose and procedures of the study and have provided written consent
Key exclusion criteria
Individuals with a history of neurological disorders, psychiatric disorders, or severe systemic diseases
Individuals who have undergone major surgery within the past 6 months
Individuals for whom significant changes in health status are anticipated during the study period
Other individuals deemed unsuitable by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Nagai |
Organization
Tokyo Women's Medical University Hospital
Division name
Rehabilitation Medicine
Zip code
162-0054
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
ntnyf092@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Nagai |
Organization
Tokyo Women's Medical University Hospital
Division name
Tokyo Women's Medical University Hospital
Zip code
162-0054
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
ntnyf092@yahoo.co.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
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
Tokyo Women's Medical University Hospital
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo
Tel
03-3353-8111
ntnyf092@yahoo.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
25K14435
Org. issuing International ID_1
Ministry of Education, Culture, Sports, Science and Technology
Study ID_2
Org. issuing International ID_2
IND to MHLW
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2025 | Year | 11 | Month | 30 | Day |
Last modified on
| 2025 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068539
