UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016487 |
|---|---|
| Receipt number | R000019147 |
| Scientific Title | An investigation of the effect of trigeminal nerve stimulation on brain activity through the modulation of slow cortical potentials |
| Date of disclosure of the study information | 2015/02/09 |
| Last modified on | 2021/08/16 16:47:04 |
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Basic information
Public title
An investigation of the effect of trigeminal nerve stimulation on brain activity through the modulation of slow cortical potentials
Acronym
An investigation of the effect of trigeminal nerve stimulation on brain activity through the modulation of slow cortical potentials
Scientific Title
An investigation of the effect of trigeminal nerve stimulation on brain activity through the modulation of slow cortical potentials
Scientific Title:Acronym
An investigation of the effect of trigeminal nerve stimulation on brain activity through the modulation of slow cortical potentials
Region
| Japan |
Condition
Condition
epilepsy, brain tumor
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To see if the trigeminal nerve stimulation (TNS) shows the anti-epileptic effect within a short time, and understand the anti-epileptic mechanism of the TNS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of epileptiform discharges at the seizure onset zone
Key secondary outcomes
Coherence values of slow cortical potentials between scalp electrodes and subdural electrodes at seizure onset zone
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Trigeminal nerve stimulation and recording of the slow cortical potentials under subdural electrodes implantation
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
| 16 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Medically intractable parietal lobe epilepsy patients undergoing chronic subdural and/or depth electrode implantation for possible epilepsy or lesion surgeries
Key exclusion criteria
Patients who disagree with this research
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Ikeda |
Organization
Kyoto University School of Medicine
Division name
Department of Epilepsy, Movement Disorders and Physiology
Zip code
6068507
Address
54, Shogoin, Sakyo-ku, Kyoto, 606-8507, JAPAN
TEL
075-751-3662
akio@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Fumuro |
Organization
International University of Health and Welfare
Division name
School of Health Sciences at Fukuoka
Zip code
8318501
Address
137-1 Enokizu, Okawa City, Fukuoka
TEL
0944-89-2034
Homepage URL
tfumuro@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Epilepsy, Movement Disorders and Physiology, Kyoto University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Epilepsy Research Foundation
Kyoto University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare, School of Health Science in Fukuoka, Department of Medical Technology and Science
Address
137-1 Enokizu, Okawa City, Fukuoka
Tel
0944-89-2000
fumuro@iuhw.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 | 02 | Month | 09 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 16 | 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 | 02 | Month | 09 | Day |
Last modified on
| 2021 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019147
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
