UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019226 |
|---|---|
| Receipt number | 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 | 2023/04/22 19:32:38 |
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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 | 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
Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
075-751-3318
akio@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Takeyama |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Epilepsy, Movement Disorders and Physiology
Zip code
606-8507
Address
Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
075-751-3772
Homepage URL
takeyama@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine, Department of Neurology
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
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Epilepsy, Movement Disorders and Physiology, Kyoto University Graduate School of Medicine
Address
Shogoin, Sakyo-ku, Kyoto, JAPAN
Tel
075-751-3772
takeyama@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
| 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 11 | Day |
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
| 2023 | 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=R000022211
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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