UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000043771
Receipt number	R000049966
Scientific Title	Epileptic network analysis using simultaneous intracranial EEG-fMRI
Date of disclosure of the study information	2021/03/29
Last modified on	2021/04/22 22:05:58

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Basic information

Public title

Epileptic network analysis using simultaneous intracranial EEG-fMRI

Acronym

Epileptic network analysis using simultaneous intracranial EEG-fMRI

Scientific Title

Epileptic network analysis using simultaneous intracranial EEG-fMRI

Scientific Title:Acronym

Epileptic network analysis using simultaneous intracranial EEG-fMRI

Region

Japan

Condition

Epilepsy

Classification by specialty

Neurology Pediatrics Psychiatry

Neurosurgery Adult Child

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

This study aims to elucidate the abnormal brain network in epilepsy.

Basic objectives2

Others

Basic objectives -Others

to elucidate the abnormal brain network in epilepsy

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

The clinical implication of the abnormal brain network delineated using intracranial EEG-fMRI

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

Subjects included in this study must fulfill the following criteria:
(1) Patients who have undergone placement of intracranial electrodes, as per their medical necessity, for pre-operative evaluation of epilepsy or brain tumor,(2) regardless of their gender.
(3) Patients who gave consent to participate. Written consent will be obtained from the patients themselves for those who are 20 years and above, capable of making informed and rational judgement. Written consent will be obtained from the their representative (for example parents or guardian) for those who are below 20 years or lack the capability to make informed and rational judgement.

Key exclusion criteria

Subjects who fulfill any of the following criteria will be excluded from this study.
1) Individuals with severe intellectual disability in whom proper communication is not possible and thus unable to stay still during the acquisition of MRI.
2) Individuals who are unable to cooperate and unable to stay still during the acquisition of MRI (for example some patients below 17 years).
3) Individuals who are contraindicated for MRI (those implanted with pacemaker or artificial cardiac valve, and those who are claustrophobic).
4) Individuals considered incompetent to participate in this study, by the attending physician.

Target sample size

Research contact person

Name of lead principal investigator

1st name Haruhiko

Middle name Khoo

Last name Kishima

Organization

Osaka University Graduate School of Medicine

Division name

Department of Neurosurgery

Zip code

565-0021

Address

2-2, Yamadaoka, Suita, Japan.

TEL

0668793652

Email

hkishima@nsurg.med.osaka-u.ac.jp

Public contact

Name of contact person

1st name Hui Ming

Middle name

Last name Khoo

Organization

Osaka University Graduate School of Medicine

Division name

Department of Neurosurgery

Zip code

565-0021

Address

2-2, Yamadaoka, Suita, Japan.

TEL

0668793652

Homepage URL

Email

khoo@nsurg.med.osaka-u.ac.jp

Sponsor or person

Institute

Osaka University

Institute

Department

Personal name

Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology (Tokyo)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Osaka University Clinical Research Review Committee

Address

2-15, Yamadaoka, Suita

Tel

06-6210-8289

Email

rinri@hp-crc.med.osaka-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2021 Year 03 Month 29 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

Enrolling by invitation

Date of protocol fixation

2021 Year 03 Month 22 Day

Date of IRB

2021 Year 04 Month 12 Day

Anticipated trial start date

2021 Year 04 Month 12 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Non-randomized non-blinded prospective case series study

Management information

Registered date

2021 Year 03 Month 28 Day

Last modified on

2021 Year 04 Month 22 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049966

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name