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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033373
Receipt No. R000038046
Official scientific title of the study Study on the influence of car driving by seizure
Date of disclosure of the study information 2018/07/12
Last modified on 2018/07/12

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Basic information
Official scientific title of the study Study on the influence of car driving by seizure
Title of the study (Brief title) 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 Kensuke Kawai
Organization Jichi Medical University
Division name Department of Neurosurgery
Address 3311-1, Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7373
Email kenkawai-tky@jichi.ac.jp

Public contact
Name of contact person Kensuke Kawai
Organization Jichi Medical University
Division name Department of Neurosurgery
Address 3311-1, Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7373
Homepage URL
Email kenkawai-tky@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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 12 Day
Anticipated trial start date
2018 Year 07 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

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


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

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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