UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023682 |
|---|---|
| Receipt number | 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 | 2024/03/09 20:40:27 |
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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 | Akio |
| Middle name | |
| Last name | Ikeda |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Epilepsy, Movement Disorders and Physiology
Zip code
606-8507
Address
54, Shogoin-kawaharacho, Sakyo-ku, Kyoto, 606-8507, JAPAN
TEL
075-751-3662
akin@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Katsuya |
| Middle name | |
| Last name | Kobayashi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Neurology
Zip code
606-8507
Address
54, Shogoin-kawaharacho, Sakyo-ku, Kyoto, 606-8507, JAPAN
TEL
075-751-3772
Homepage URL
31258a@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
Kyoto University
Ehime University
Ritsumeikan University
RIKEN
Hokkaido University
Kyoto Sangyo University
Kyushu Institute of Technology
Fukuoka Institute of Technology
INS Institut de Neurosciences des Systemes, UMR INSERM 1106, Aix Marseille Universite
Department of Neurology, Johns Hopkins University School of Medicine
Natbrainlab, Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, King's College London
Epilepsy Center, Cleveland Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
| 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
There have been no 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
| 2016 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We have not yet reached the target number of patients and are still recruiting. Because the number of patients was less than initially expected due to the COVID-19 pandemic, the research period was extended for 4 years with the approval of the ethics committee of our institute (expected end date of the study: December 12, 2026).
Management information
Registered date
| 2016 | Year | 08 | Month | 19 | Day |
Last modified on
| 2024 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025754
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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