UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043583 |
|---|---|
| Receipt number | R000049720 |
| Scientific Title | Analysis of microscopic structure and functional connectivity for headache with increasing intracranial pressure |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2023/09/14 15:03:07 |
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Basic information
Public title
Analysis of microscopic structure and functional connectivity for headache with increasing intracranial pressure
Acronym
Analysis of headache with increasing intracranial pressure
Scientific Title
Analysis of microscopic structure and functional connectivity for headache with increasing intracranial pressure
Scientific Title:Acronym
Analysis of headache with increasing intracranial pressure
Region
| Japan |
Condition
Condition
increasing intracranial pressure
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of microstructure and functional connectivity for headache with non-invasively caused increasing intracranial pressure
Basic objectives2
Others
Basic objectives -Others
increasing intracranial pressure, headache, papilledema, internal jugular venous thrombosis which onset in microgravity in space
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Headache pattern and intracranial pressure after starting HDBR 10min
2.Fractional Anisotropy (FA) and Functional Connectivity (FC) before and after starting HDBR
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
First, resting state functional magnetic resonance imaging, DTI, NODDI, T1 sagittal, FLAIR axial, and ASL are performed in the horizontal supine position. The imaging time is just over 30 minutes. The patient is then placed in a supine position with a 10 degree head down position on a specially designed MRI table for 10 minutes of follow-up. During this time, a physician will be present to monitor symptoms and vital signs, and HDBR and MRI will be discontinued if symptoms such as severe headache, dizziness, or mood swings occur. 10 minutes later, or if a headache occurs during head-down, the nature of the headache and the Numerical Rating Scale will be evaluated. After 10 minutes or during head down, if headache occurs, rsfMRI, DTI and ASL will be performed again to compare the symptom and image changes before and after HDBR, and to examine the microstructure and brain function.
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 adult who don't have chronic headache and intracranial disease
Key exclusion criteria
1. Currently undergoing treatment for an underlying disease
2. Presence of organic intracranial lesions such as cerebrovascular disease or tumor
3. History of chronic headache
4. Pregnant
5.Currently participating or planning to participate in other clinical trials
6. claustrophobia
7. Inappropriate for MRI imaging such as pacemaker or implant
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Shibata |
Organization
University of Tsukuba
Mito Kyodo General Hospital
Division name
Neurosurgery
Zip code
3100015
Address
3-2-7, Miyamachi, Mito city, Ibaraki prefecture, Japan
TEL
029-231-2371
yshibata@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Shibata |
Organization
Mito Kyodo General Hospital
Division name
Neurosurgery
Zip code
310-0015
Address
3-2-7, Miyamachi, Mito city, Ibaraki prefecture, Japan
TEL
029-231-2371
Homepage URL
yshibata@md.tsukuba.ac.jp
Sponsor or person
Institute
Mito Kyodo General Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Mito Kyodo General Hospital
Address
3-2-7, Miyamachi, Mito city, Ibaraki prefecture, Japan
Tel
029-231-2371
yshibata@md.tsukuba.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
| 2021 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/37587626/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37587626/
Number of participants that the trial has enrolled
20
Results
Optic nerve sheath diameter: significantly increased after Head down
DTI analysis: No significant difference in FA before and after Head down AD, MD significantly increased after Head down
FC: Significant decrease in FC in cerebellum-middle frontal gyrus, inferior frontal gyrus, deltoid and orbitofrontal gyrus after Head down
Significantly higher FC before Head down (before headache onset) in the headache group
Significantly lower FC in most of the headache group after head down (after headache onset)
Results date posted
| 2023 | Year | 09 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Subjects recruited from April to October 2021 at the Neurosurgery Department, Mito Kyodo Hospital
20 healthy adults without chronic headache and intracranial disease
Mean age 46.6
Gender Woman 10 Man 10
Participant flow
After explaining the study and obtaining written consent, an appointment for MRI examination will be made. First, rsfMRI(resting-state functional magnetic resonance imaging)+DTI, NODDI, T1 sagittal, FLAIR axial, and ASL are performed in the horizontal supine position. The imaging time is a little over 30 minutes. The patient is then placed in a 10-degree head-down position in the supine position for 10 minutes using a specially designed tilt table on the MRI table, in accordance with previous studies. After 10 minutes, or if headache occurs during head down, the patient will be asked to rate the severity of the headache and assessed by Numerical Rating Scale(NRS), and rsfMRI+DTI and ASL should be performed again without any modification.
Adverse events
none
Outcome measures
Numerical Rating Scale (NRS)
Optic nerve sheath diameter
FA, AD, RD, MD, FC
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2021 | Year | 03 | Month | 11 | Day |
Last modified on
| 2023 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049720
