UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044980 |
|---|---|
| Receipt number | R000051393 |
| Scientific Title | Assessment of cerebral blood flow using arterial spin labeling methods for patients with refractory epilepsy |
| Date of disclosure of the study information | 2021/07/30 |
| Last modified on | 2024/07/30 15:02:08 |
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Basic information
Public title
Assessment of cerebral blood flow using arterial spin labeling methods for patients with refractory epilepsy
Acronym
ASL study for refractory epilepsy
Scientific Title
Assessment of cerebral blood flow using arterial spin labeling methods for patients with refractory epilepsy
Scientific Title:Acronym
ASL study for refractory epilepsy
Region
| Japan |
Condition
Condition
epilespy
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assuming of seizure onset zone (SOZ) by conventional non-invasive study often were difficult in some patients with refractory epilepsy. Recently, it was reported that postictal hypoperfusion detected by arterial spin labeling (ASL) MRI within 60 min of a habitual seizure may provide useful data to localize the SOZ. In this study, we assess whether the method using ASL is practical to assume the SOZ.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The concordance of more than 30% postictal CBF reductions compared with baseline and presumed seizure onset zone by others studies.
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) a patient with refractory epilepsy
2) a patient safely scanned by MRI after seizure
3) a patient admitted for long term EEG monitoring.
4) a patient provide informed consent
Key exclusion criteria
1) a patient not corporative for MRI scan because of severe mental or cognitive disorders
2) a patient cannot keep at rest
3) a patient with metal non-adaptive MRI, ex. implantation of pacemaker, artificial valve.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yamazoe |
Organization
Seirei Hamamatsu General Hospital
Division name
Neurosurgery
Zip code
430-8558
Address
2-12-12, Sumiyoshi, naka-ku, Hamamatsu, Sizuoka
TEL
053-474-2222
t-zoe@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yamazoe |
Organization
Seirei Hamamatsu General Hospital
Division name
Neurosurgery
Zip code
430-8558
Address
2-12-12, Sumiyoshi, naka-ku, Hamamatsu, Sizuoka
TEL
053-474-2222
Homepage URL
t-zoe@sis.seirei.or.jp
Sponsor or person
Institute
Seirei Hamamatsu General Hospital
Institute
Department
Personal name
Funding Source
Organization
Self
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seirei Hamamatsu General Hospital
Address
2-12-12, Sumiyoshi, naka-ku, Hamamatsu, Sizuoka
Tel
0534742222
m-kimata@sis.seirei.or.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 | 07 | 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
0
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
Terminated
Date of protocol fixation
| 2021 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) subjects' background; age, gender, epilepsy condition
2) data of conventional non-invasive study for refractory epilepsy: EEG, MEG, MRI SPECT, PET, Wada-test, invasive monitoring.
3) 3 tesla MRI scan; anatomical, interictal ASL and postictal ASL
Management information
Registered date
| 2021 | Year | 07 | Month | 28 | Day |
Last modified on
| 2024 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051393
