UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050589 |
|---|---|
| Receipt number | R000053537 |
| Scientific Title | Study of MRI imaging with upper body raised for diagnosis of cerebrospinal fluid hypovolemia |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2025/02/20 14:56:29 |
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Basic information
Public title
Study of MRI imaging with upper body raised for diagnosis of cerebrospinal fluid hypovolemia
Acronym
MURC study
Scientific Title
Study of MRI imaging with upper body raised for diagnosis of cerebrospinal fluid hypovolemia
Scientific Title:Acronym
MURC study
Region
| Japan |
Condition
Condition
cerebrospinal fluid hypovolemia
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the collapse of the dural sac by changing the shape of the dural sac due to changes in body position, and verify its effectiveness as a diagnostic method for cerebrospinal fluid hypovolemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We compare MRI images of the dural sac taken in the normal supine position with those taken with the upper body slightly elevated.
Key secondary outcomes
We compare MRI images of patients with cerebrospinal fluid hypovolemia and healthy subjects. We also verify the presence or absence of changes in MRI images in healthy subjects.
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
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
After MRI imaging in the normal supine position, change to the position where the upper body is raised and perform imaging under the same conditions.
20 patients
Interventions/Control_2
We will take pictures of healthy people under the same conditions as in Intervention 1.
10 healthy people
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
Patients [20 people]
1. Patients with orthostatic headache and suspected cerebrospinal fluid hypovolemia
2. 18 years old or older
Control [10 people]
1.Healthy person over 18 years old
Key exclusion criteria
1. Patient who cannot undergo MRI imaging
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Nakai |
Organization
Kochi Medical School Hospital
Division name
Neurosurgery
Zip code
783-8505
Address
Kohasu 185-1, Okocho, Nankoku, Kochi, Japan
TEL
+819071494469
enakai@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Nakai |
Organization
Kochi Medical School Hospital
Division name
Neurosurgery
Zip code
783-8505
Address
Kohasu 185-1, Okocho, Nankoku, Kochi, Japan
TEL
+81888802397
Homepage URL
enakai@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Eiichi Nakai
Funding Source
Organization
Kochi 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
Ethical Review Board of Kochi Medical School
Address
Kohasu 185-1, Okocho, Nankoku, Kochi, Japan
Tel
+81888802180
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
| 2023 | Year | 04 | 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
30
Results
The recruitment of 10 controls and 20 patients is complete.
In the control group, 7 showed no positional imaging changes, while 3 were inconclusive.
Among 20 patients, 13 were diagnosed with CSF hypovolemia, 2 were ruled out, and 5 were inconclusive.
One case was excluded due to motion artifacts. Of the remaining 12, 10 were positive on Semi-Fowler Position MRI. No positive findings were seen in the 2 ruled-out cases.
Results date posted
| 2025 | Year | 02 | Month | 20 | Day |
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
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 01 | 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
| 2023 | Year | 03 | Month | 15 | 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=R000053537
