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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000019226
Receipt No. R000022211
Scientific Title Development and investigation of mechanism of neuromodulation by brain electrostimulation
Date of disclosure of the study information 2015/11/02
Last modified on 2015/11/23

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Basic information
Public title Development and investigation of mechanism of neuromodulation by brain electrostimulation
Acronym Development and investigation of mechanism of neuromodulation by brain electrostimulation
Scientific Title Development and investigation of mechanism of neuromodulation by brain electrostimulation
Scientific Title:Acronym Development and investigation of mechanism of neuromodulation by brain electrostimulation
Region
Japan

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

Objectives
Narrative objectives1 The objectives of the current study are the development of the methods of neuromodulation using brain electrostimulation, and the investigation of mechanism of neuromodulation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes In the study of enhancement or inhibition of normal brain function by brain electrostimulation, primary outcome is behavioral change in tasks designed for the evaluation of brain function. The timing of assessment is between the intervention and epileptogenic focus resection surgery (1 to 2 weeks after the intervention).
Key secondary outcomes In the study of inhibition of epileptogenecity by brain electrostimulation, primary outcome is the change of the frequency of epileptic discharge in electrocorticogram.The timing of assessment is between the intervention and epileptogenic focus resection surgery (1 to 2 weeks after the intervention).

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 The subjects of the current study are the patients who have chronic subdural or depth electrode implantation for epileptogenic focus or brain tumor resection surgery. We will investigate the enhancement or inhibition effects in normal brain function, such as motor, sensory, or memory, or inhibition effect in epileptogenecity caused by brain electrostimulation via the implanted electrodes. Interventions are performed during the electrode implantation period, basically about 2 weeks. Stimulus parameters are modulated within the limits of total electrical charge density per unit area used in our institute for clinical functional mapping. The duration of the interventional study is 1 to 3 hours per 1 day.
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 When patients understand the current study and the informed consent by the patient or the person in parental authority is achieved.
Key exclusion criteria When patients don't understand the current study well and the informed consent by the patient or the person in parental authority is not achieved.
When the physician in charge of the patient think that the research study is medically disagreeable.
Target sample size 5

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 Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL 075-751-3318
Email akio@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirofumi Takeyama
Organization Kyoto University Graduate School of Medicine
Division name Department of Neurology
Zip code
Address Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL 075-751-3772
Homepage URL
Email takeyama@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine, Department of Neurology
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
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
2015 Year 11 Month 02 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
2015 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 11 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
2015 Year 10 Month 03 Day
Last modified on
2015 Year 11 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022211

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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