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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029423
Receipt No. R000033613
Scientific Title Observation of driving behavior during epileptic seizure, using driving simulator.
Date of disclosure of the study information 2017/10/08
Last modified on 2019/08/09

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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 100

Research contact person
Name of lead principal investigator
1st name Koji
Middle name
Last name Iida
Organization Hiroshima University Hospital
Division name Neurosurgery/Epilepsy centor
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 centor
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 centor
Institute
Department

Funding Source
Organization Hiroshima University Hospital
Neurosurgery/Epilepsy centor
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
2019 Year 08 Month 09 Day


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

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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