UMIN-CTR Clinical Trial

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
Email	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
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	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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019147