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

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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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name