UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034244 |
|---|---|
| Receipt number | R000039034 |
| Scientific Title | Accurate depth electrode placement by neuronavigation-guided frameless stereoelectroencephalography (SEEG) leads to better subsequent surgical outcomes |
| Date of disclosure of the study information | 2018/09/23 |
| Last modified on | 2018/09/23 10:38:37 |
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Basic information
Public title
Accurate depth electrode placement by neuronavigation-guided frameless stereoelectroencephalography (SEEG) leads to better subsequent surgical outcomes
Acronym
Accurate DE placement leads to better surgical outcomes
Scientific Title
Accurate depth electrode placement by neuronavigation-guided frameless stereoelectroencephalography (SEEG) leads to better subsequent surgical outcomes
Scientific Title:Acronym
Accurate DE placement leads to better surgical outcomes
Region
| Japan |
Condition
Condition
Epilepsy
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to statistically compare the accuracy of depth electrode placement and epilepsy surgery outcome between the groups of surface matching registration and iCT registration.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative epilepsy surgery outcome
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) underwent DE placement; 2) used neuronavigation system; and 3) were followed-up for more than 10 months.
Key exclusion criteria
1)We excluded patients who had only undergone SE placement without DEs. 2)We also excluded patients for whom electrodes were manually repositioned, since intraoperative real-time 3-dimensional (3D) rendered brain images and electrode visualization on fusion images are available in our hospital
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ayataka Fujimoto |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of epilepsy
Zip code
Address
2-12-12 Sumiyoshi Nakaku Hamamatsu
TEL
053-474-2222
afujimotoscienceacademy@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayataka Fujimoto |
Organization
Department of epilepsy
Division name
Comprehensive epilepsy center
Zip code
Address
2-12-12 Sumiyoshi Nakaku Hamamatsu
TEL
053-474-2222
Homepage URL
afujimotoscienceacademy@gamil.com
Sponsor or person
Institute
Seirei Hamamatsu general hospital
Institute
Department
Personal name
Funding Source
Organization
Seirei Hamamatsu general hospital
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
Address
Tel
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
| 2018 | Year | 09 | Month | 23 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Before submission to a journal
Management information
Registered date
| 2018 | Year | 09 | Month | 23 | Day |
Last modified on
| 2018 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039034
