UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058517 |
|---|---|
| Receipt number | R000066182 |
| Scientific Title | Quantification of cerebrospinal fluid movement in the brain using breathing in normal volunteers: A study using time-SLIP MRI |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/09/02 17:54:01 |
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Basic information
Public title
Quantification of respiratory fluctuations in spinal cerebrospinal fluid in normal volunteers
Acronym
Quantification of respiratory fluctuations in cerebrospinal fluid
Scientific Title
Quantification of cerebrospinal fluid movement in the brain using breathing in normal volunteers: A study using time-SLIP MRI
Scientific Title:Acronym
Quantification of respiratory fluctuations in spinal CSF using time-SLIP
Region
| Japan |
Condition
Condition
normal volunteer
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There is a close relationship between breathing and the movement of cerebrospinal fluid within the spinal canal. It is known that tumors or nerves inside the spinal canal can shift due to breathing, which is believed to contribute to cerebrospinal fluid movement. While previous reports have documented this fluid movement, they primarily rely on specialized MRI imaging and analysis techniques used for research purposes. These methods are time-consuming and not widely applicable in clinical settings. In this study, we aim to measure cerebrospinal fluid movement and evaluate its extent using the Time-SLIP MRI technique, a standard imaging method available in conventional MRI scanners.
Basic objectives2
Others
Basic objectives -Others
Observation of normal CSF movement
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether movement of CSF within the spinal canal can be confirmed during deep breathing
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
Have tattoos, permanent makeup, or metal implants
Unable to rule out the possibility of pregnancy (women only)
Any other conditions that may pose a risk to MRI imaging
Have a history of spinal or spinal cord disorders
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ito |
Organization
Fukushima Medical University, School of Medicine
Division name
Department of Radiology and Nuclear Medicine
Zip code
960-1295
Address
1Hikariga-oka, Fukushima City, Fukushima, Japan
TEL
0245471111
rad@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Yamakuni |
Organization
Fukushima Medical University, School of Medicine
Division name
Department of Radiology and Nuclear Medicine
Zip code
960-1295
Address
1Hikariga-oka, Fukushima City, Fukushima, Japan
TEL
0245471111
Homepage URL
yamakuni@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University Ethics Committee
Address
1Hikariga-oka, Fukushima City, Fukushima, Japan
Tel
0245471111
rs@fmu.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 | 08 | Month | 01 | 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 | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Using Time-SLIP MRI, measure the movement of cerebrospinal fluid (CSF) within the spinal canal. At each vertebral level, perform two breathing patterns: deep breathing and quiet breathing.
Analyze the differences in CSF movement based on breathing patterns and evaluate variations in CSF dynamics at each vertebral level.
Management information
Registered date
| 2025 | Year | 07 | Month | 18 | Day |
Last modified on
| 2025 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066182
