UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056367 |
|---|---|
| Receipt number | R000063998 |
| Scientific Title | Study of MRI imaging with upper body raised for diagnosis of cerebrospinal fluid hypovolemia 2nd |
| Date of disclosure of the study information | 2024/12/05 |
| Last modified on | 2025/02/20 09:49:20 |
* 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
Study of MRI imaging with upper body raised for diagnosis of cerebrospinal fluid hypovolemia 2nd
Acronym
MURC study 2nd
Scientific Title
Study of MRI imaging with upper body raised for diagnosis of cerebrospinal fluid hypovolemia 2nd
Scientific Title:Acronym
MURC study 2nd
Region
| Japan |
Condition
Condition
Cerebrospinal fluid hypovolemia
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have conducted multiple clinical studies related to cerebrospinal fluid (CSF) hypovolemia. In one of these studies, we performed MRI imaging in both the standard supine position and a mildly elevated upper body position on patients aged 18 years or older who were suspected of having CSF hypovolemia. As controls, we also recruited healthy individuals and performed MRI imaging under the same conditions. In patients with CSF hypovolemia, changes in the shape of the lumbar dural sac were observed, while no such changes were detected in healthy individuals. These findings may be attributed to the movement of cerebrospinal fluid within a depleted and collapsed dural sac due to insufficient CSF.
Since this study was exploratory, we did not examine the correlation between these findings and cerebrospinal fluid pressure, which is a critical indicator of CSF hypovolemia. However, the results suggest that positional changes may induce shape alterations in the dural sac in patients with CSF hypovolemia. Therefore, this study aims to investigate the correlation between these shape changes and cerebrospinal fluid pressure in patients with CSF hypovolemia.
Compared to standard MRI imaging, positional change MRI provides more information by allowing comparisons between two images, which may significantly contribute to the diagnosis of CSF hypovolemia. Establishing this method would hold substantial significance in the clinical diagnosis of the condition.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative evaluation of MRI image changes induced by postural adjustments and their correlation with cerebrospinal fluid pressure.
Key secondary outcomes
1. Measurement of the anteroposterior diameter of the dural sac in the lumbosacral region using whole-spine MRI
2. Measurement of signal intensity changes in the lumbosacral region due to postural adjustments
3. Measurement of the angle of the dural sac apex at the terminal end of the lumbosacral dural sac
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Consent will be obtained from patients suspected of cerebrospinal fluid (CSF) hypovolemia who are likely to undergo lumbar puncture as part of their routine examination. Lumbar puncture for CSF pressure measurement will not be performed for research purposes.
After obtaining consent, the initial MRI imaging will be conducted in the supine position. Subsequently, another MRI scan will be performed under the same conditions with the upper body slightly elevated. The MRI process involves approximately 15 minutes of imaging in the standard supine position, followed by another 15 minutes of imaging with the upper body slightly elevated.
MRI images obtained in these two positions will be compared to examine changes in the shape of the brain, spinal cord, and the sacs containing CSF. Additionally, the correlation between these changes and the CSF pressure measured during the subsequent lumbar puncture will be investigated.
All imaging will be completed in a single session, and no additional imaging will be scheduled for a different day. Furthermore, no contrast agents or other drugs will be used. Basic information such as sex, age at the time of consent, and medical history (particularly any history of trauma) will also be collected.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with orthostatic headaches suspected of having cerebrospinal fluid (CSF) hypovolemia
2. Age 18 years or older
3. Patients undergoing cerebrospinal fluid pressure measurement via lumbar puncture
Key exclusion criteria
1. Patients for whom MRI imaging is not feasible.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Nakai |
Organization
Kochi Medical School, Kochi University
Division name
Neurosurgery
Zip code
783-8505
Address
185-1 Kohasu, Oko-cho, Nankoku, Kochi, Japan
TEL
088-880-2397
enakai@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Nakai |
Organization
Kochi Medical School, Kochi University
Division name
Neurosurgery
Zip code
783-8505
Address
185-1 Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL
0888802397
Homepage URL
enakai@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Ethical Review Board of Kochi Medical School
Address
Kohasu 185-1, Okocho, Nankoku, Kochi, Japan Kouchi
Tel
0888802180
is21@kochi-u.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
| 2024 | Year | 12 | Month | 05 | 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
| 2024 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2024 | Year | 12 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063998
