UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043058 |
|---|---|
| Receipt number | R000049008 |
| Scientific Title | Factors of seizure outcome after epilepsy surgery |
| Date of disclosure of the study information | 2021/01/30 |
| Last modified on | 2022/01/21 10:27:37 |
* 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
Factors of seizure outcome after epilepsy surgery
Acronym
Factors of seizure outcome after epilepsy surgery
Scientific Title
Factors of seizure outcome after epilepsy surgery
Scientific Title:Acronym
Factors of seizure outcome after epilepsy surgery
Region
| Japan |
Condition
Condition
intractable epilepsy
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effects of various factors involved in epilepsy surgery on seizure outcome
Basic objectives2
Others
Basic objectives -Others
n/a
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between seizure outcome and various medical information
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
| 2 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. patients wihtintractable epilepsy
2. patients implanted electrodes
3. patients with undergone EEG monitoring
4. patients with undergone brain functional mapping
Key exclusion criteria
1. If complications occur during the postoperative course
2. Patients judged by the principal investigator to be inappropriate as research subjects
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuich |
| Middle name | |
| Last name | Kubota |
Organization
Tokyo Women's Medical University,Adachi Medical Center
Division name
Neurosurgery
Zip code
1238558
Address
Kohoku 4-33-1, Adachi, Tokyo
TEL
03-3857-0111
yuchan2913@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Kubota |
Organization
Tokyo Women's Medical University,Adachi Medical Center
Division name
Neurosurgery
Zip code
1168567
Address
Kohoku 4-33-1, Adachi, Tokyo
TEL
03-3857-0111
Homepage URL
yuchan2913@yahoo.co.jp
Sponsor or person
Institute
Tokyo Women's Medical University,Adachi Medical Center
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
Tokyo Women's Medical University,Adachi Medical Center
Address
Kohoku 4-33-1, Adachi, Tokyo
Tel
03-3857-0111
yuchan2913@yahoo.co.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 | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2020 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
n/a
Management information
Registered date
| 2021 | Year | 01 | Month | 20 | Day |
Last modified on
| 2022 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049008
