UMIN-CTR Clinical Trial

Basic information
Public title	Observation of driving behavior during epileptic seizure, using driving simulator.
Acronym	Observation of driving behavior during epileptic seizure.
Scientific Title	Observation of driving behavior during epileptic seizure, using driving simulator.
Scientific Title:Acronym	Observation of driving behavior during epileptic seizure.
Region	Japan

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

Objectives
Narrative objectives1	Purpose of this study is to observe the driving behavior during epileptic seizure, using Video Electroencephalogram(VEEG) and driving simulator(DS). By comparing driving behavior before and after the seizure, we can know the changes due to epileptic seizure.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Electroencephalogram while using DS. Movie while using DS. Driving operation (operation of pedal, staring) Vehicle motion (speed / inter-vehicle distance, lateral position (wandering)) Change in posture (head, upper body) Facial expression (movie recording)
Key secondary outcomes

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	Diagnosis
Type of intervention	Behavior,custom
Interventions/Control_1	Observe and record the driving behavior of epilepsy patients before and after the seizure using DS.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients expected to be able to drive a car. 2.Patients who diagnosed as epilepsy or suspected as epilepsy. 3.Patients who need VEEG for diagnose. 4.Can be hospitalized for VEEG. 5.Written informed consent.
Key exclusion criteria	1.Difficulty to participate using DS because of physical or mental disorder. 2.Difficulty to participate because of status epileptics. 3.Difficulty to participate because of other reasons which was judged by a doctor.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Koji Middle name Last name Iida
Organization	Hiroshima University Hospital
Division name	Neurosurgery/Epilepsy center
Zip code	734-8551
Address	1-2-3 Kasumi, Minamiku, Hiroshima-shi, Hiroshima-ken 734-8551, JAPAN
TEL	082-257-5227
Email	iidak@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Koji Middle name Last name Iida
Organization	Hiroshima University Hospital
Division name	Neurosurgery/Epilepsy center
Zip code	7348551
Address	1-2-3 Kasumi, Minamiku, Hiroshima-shi, Hiroshima-ken 734-8551, JAPAN
TEL	082-257-5227
Homepage URL
Email	iidak@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Hospital Neurosurgery/Epilepsy center
Institute
Department

Funding Source
Organization	Hiroshima University Hospital Neurosurgery/Epilepsy center
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	Hiroshima University Clinical Research Ethics Review Committee
Address	1-2-3 Kasumi, Minamiku, Hiroshima-shi, Hiroshima-ken 734-8551, JAPAN
Tel	082-257-5907
Email	kasumi-kenkyu@office.hiroshima-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	2017 Year 10 Month 08 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	Open public recruiting
Date of protocol fixation	2017 Year 08 Month 31 Day
Date of IRB	2017 Year 08 Month 31 Day
Anticipated trial start date	2017 Year 10 Month 08 Day
Last follow-up date	2026 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 10 Month 04 Day
Last modified on	2020 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033613