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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016487
Receipt No. 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 2016/02/09

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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
Middle name
Last name Akio Ikeda
Organization Kyoto University School of Medicine
Division name Department of Epilepsy, Movement Disorders and Physiology
Zip code
Address 54, Shogoin, Sakyo-ku, Kyoto, 606-8507, JAPAN
TEL 075-751-3662
Email akio@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyuki Fumuro
Organization International University of Health and Welfare
Division name School of Health Sciences at Fukuoka
Zip code
Address 137-1 Enokizu, Okawa City, Fukuoka
TEL 0944-89-2034
Homepage URL
Email tfumuro@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Epilepsy, Movement Disorders and Physiology, Kyoto University School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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
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 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 Enrolling by invitation
Date of protocol fixation
2015 Year 02 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 09 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 02 Month 09 Day
Last modified on
2016 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019147

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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