UMIN-CTR Clinical Trial

Basic information
Public title	Study on the influence of car driving by seizure
Acronym	Seizure and car driving function
Scientific Title	Study on the influence of car driving by seizure
Scientific Title:Acronym	Seizure and car driving function
Region	Japan

Condition
Condition	Epilepsy
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clearly the influence of car driving by seizure. We record the motor function and physiology function while the patient who are undergoing video electroencephalography is performing the virtual driving task.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Presence or absence of decline in car driving function by seizure
Key secondary outcomes	Motor function - Handle / pedal operation status Physiological function - Facial expression - Eye movement - Head pulse / head body temperature

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	Behavior,custom
Interventions/Control_1	The patient carries out virtual driving tasks.
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	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	- Inpatients who undergo long-term electroencephalogram simultaneous recording test (D235-1) - Inpatients who undergo long-term continuous intracranial electroencephalographic examination (D235-2)
Key exclusion criteria	- people with disturbance / consciousness disturbance - people with severe intellectual disability - People who is difficult to express voluntary participation - Children under 15 years of age.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kensuke Middle name Last name Kawai
Organization	Jichi Medical University
Division name	Department of Neurosurgery
Zip code	3290498
Address	3311-1, Yakushiji, Shimotsuke, Tochigi
TEL	0285-58-7373
Email	kenkawai-tky@jichi.ac.jp

Public contact
Name of contact person	1st name Tomoaki Middle name Last name Ban
Organization	Jichi Medical University
Division name	Department of Neurosurgery
Zip code	3290498
Address	3311-1, Yakushiji, Shimotsuke, Tochigi
TEL	0285-58-7373
Homepage URL
Email	van.tomoaki@jichi.ac.jp

Sponsor
Institute	Jichi Medical University
Institute
Department

Funding Source
Organization	Jichi Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Jichi Medical University
Address	3311-1, Yakushiji, Shimotsuke, Tochigi
Tel	0285-58-7550
Email	rinri@jichi.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	2018 Year 07 Month 12 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	2018 Year 06 Month 12 Day
Date of IRB	2018 Year 10 Month 30 Day
Anticipated trial start date	2018 Year 11 Month 07 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 07 Month 12 Day
Last modified on	2021 Year 07 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038046