UMIN-ICDS 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

Email

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


Email

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


Email



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/icdr_e/ctr_view.cgi?recptno=R000039034


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name