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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023682
Receipt No. R000025754
Scientific Title Elucidation of human brain network and functional plasticity in patients with epilepsy: a cortico-cortical evoked potential study using an intracranial electrode
Date of disclosure of the study information 2016/08/19
Last modified on 2017/08/20

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Basic information
Public title Elucidation of human brain network and functional plasticity in patients with epilepsy: a cortico-cortical evoked potential study using an intracranial electrode
Acronym Elucidation of human brain network and functional plasticity in patients with epilepsy
Scientific Title Elucidation of human brain network and functional plasticity in patients with epilepsy: a cortico-cortical evoked potential study using an intracranial electrode
Scientific Title:Acronym Elucidation of human brain network and functional plasticity in patients with epilepsy
Region
Japan North America Europe

Condition
Condition Epilepsy, Brain tumor, Cerebral vascular malformation
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to elucidate the human brain network and functional plasticity in patients with epilepsy by means of cortico-cortical evoked potentials (CCEPs) using intracranial electrodes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cortico-cortical evoked potentials (CCEPs), subcortico-cortical evoked potentials (SCEPs), and stimulus-induced wide-band brain activities recorded from intracranial electrodes elicited by single pulse electrical stimuli to the cerebral cortex and white matter.
Key secondary outcomes Activities recorded from microelectrodes in case of simultaneous intracranial macroelectrodes and microelectrode recording.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Single-pulse or paired-pulse electrical stimuli will be applied bipolarly to a pair of adjacent intracranial electrodes at the stimulus intensity within safe limits. We aim to elucidate the static and dynamic features of pathological and physiological brain networks.
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
6 years-old <=
Age-upper limit
89 years-old >=
Gender Male and Female
Key inclusion criteria We will recruit the patients with medically intractable partial epilepsy and those with neurosurgical diseases.
Key exclusion criteria A patient whose consent can not be obtained.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Ikeda
Organization Kyoto University Graduate School of Medicine
Division name Department of Epilepsy, Movement Disorders and Physiology
Zip code
Address 54, Shogoin-kawaharacho, Sakyo-ku, Kyoto, 606-8507, JAPAN
TEL 075-751-3662
Email akin@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuya Kobayashi
Organization Kyoto University Graduate School of Medicine
Division name Department of Neurology
Zip code
Address 54, Shogoin-kawaharacho, Sakyo-ku, Kyoto, 606-8507, JAPAN
TEL 075-751-3772
Homepage URL
Email 31258a@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Neurology, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization KAKENHI(Grants-in-Aid for Scientific Research), The Ministry of Education,Culture,Sports,Science and Technology (MEXT)
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2016 Year 08 Month 19 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
2016 Year 08 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 09 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

Management information
Registered date
2016 Year 08 Month 19 Day
Last modified on
2017 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025754

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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