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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006313
Receipt No. R000007467
Scientific Title Optimization of methods to suppress afterdischarges in direct cortical electrical stimulation
Date of disclosure of the study information 2011/11/01
Last modified on 2012/09/08

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Basic information
Public title Optimization of methods to suppress afterdischarges in direct cortical electrical stimulation
Acronym Optimization of methods to suppress afterdischarges in direct cortical electrical stimulation
Scientific Title Optimization of methods to suppress afterdischarges in direct cortical electrical stimulation
Scientific Title:Acronym Optimization of methods to suppress afterdischarges in direct cortical electrical stimulation
Region
Japan

Condition
Condition Epilepsy
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Additional brief pulse cortical stimulations are reported to suppress afterdischarges induced by direct cortical stimulation during functional mapping of patients with subdural electrode implantation for possible epilepsy or lesion surgeries before they evolve into clinical seizures. We aim to optimize parameters such as interval between the stimulation which caused afterdischarges and a brief pulse cortical stimulation, and duration of a brief pulse cortical stimulation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Electroencephalographic data during and after direct cortical electrical stimulation is to be analyzed. Statistical methods such as Student's t-test or analysis of variance will be used to analyze parameters such as the rate of afterdischarge suppression, interval between the stimulation which induced afterdischarges and a brief pulse cortical stimulation, and the duration of brief pulse cortical stimulation. Spectrogram is to be used to analyze the relationship between frequency changes of electroencephalographic waveform and timing of a brief pulse cortical stimulation.
Key secondary outcomes

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 Brief pulse cortical stimulation will be added in order to suppress afterdischarges induced by direct cortical stimulation. Intensity and frequency of brief pulse cortical stimulation will be equivalent to the stimulation which induced the afterdischarges. Duration of brief pulse cortical stimulation will be shorter than the stimulation which induced the afterdischarges, and will be generally shorter than 1 second.
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
10 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Medically intractable epilepsy patients undergoing subdural and/or depth electrode implantation for possible epilepsy or lesion surgeries.
Key exclusion criteria When an informed consent is not obtained.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Ikeda
Organization Kyoto University School of Medicine
Division name Department of Neurology
Zip code
Address 54, Shogoin, Sakyo-ku, Kyoto, 606-8508, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoto University School of Medicine
Division name Department of Neurology
Zip code
Address 54, Shogoin, Sakyo-ku, Kyoto, 606-8508, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Kyoto University School of Medicine
Institute
Department

Funding Source
Organization Japan Society of the Promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Nihon Kohden Corporation
Name of secondary funder(s) National Center of Neurology and Psychiatry

Takeda Science Foundation

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
2011 Year 11 Month 01 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 Open public recruiting
Date of protocol fixation
2011 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 11 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 1)In this study, we also plan to optimize amplifier circuits of an electroencephalographic recorder in order to terminate electrode saturation due to a cortical stimulation, and to detect afterdischarges earlier so that neccessary brief pulse cortical stimulations can be given promptly, which will contribute to safer practice of functional cortical mapping.
2)Also, we plan to integrate a cortical stimulator (MS-120B, Nihon Kohden Corporation) and a switch box (MS-120B, Nihon Kohden Corporation), which uses computer software to switch electrodes to stimulate, in order to carry out cortical functional mapping more safely and efficiently (MS-210B and PE-210A have been approved under the Pharmaceutical Affairs Act in Japan.).

Management information
Registered date
2011 Year 09 Month 08 Day
Last modified on
2012 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007467

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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