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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019940
Receipt No. R000023027
Scientific Title Seizure Outcomes and Predictors of Recurrent Post-stroke Seizure:A prospective observational cohort study
Date of disclosure of the study information 2015/11/29
Last modified on 2019/08/29

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Basic information
Public title Seizure Outcomes and Predictors of Recurrent Post-stroke Seizure:A prospective observational cohort study
Acronym PROgnosis of Post Stroke Epilepsy (PROPOSE) study
Scientific Title Seizure Outcomes and Predictors of Recurrent Post-stroke Seizure:A prospective observational cohort study
Scientific Title:Acronym PROgnosis of Post Stroke Epilepsy (PROPOSE) study
Region
Japan

Condition
Condition Post stroke seizure
Classification by specialty
Neurology Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify reliable predictors of recurrent seizure in patients with late seizures and to evaluate the outcome of different AED regimens for secondary prevention.
Basic objectives2 Others
Basic objectives -Others We compared baseline clinical characteristics and post-stroke treatment regimens between recurrent and non-recurrent PSS patients to identify factors predictive of recurrence.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes recurrence of post stroke seizure
Key secondary outcomes compliance of antiepileptic drugs

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients diagnosed with seizure and selected patients with a history of preceding stroke. seizures occurring at least two weeks after stroke were defined as late seizures.
Key exclusion criteria 1. acute symptomatic seizure
2. non poststroke seizure
3. patient who reject to be recruited
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Tomotaka
Middle name
Last name Tanaka
Organization National Cerebral and Cardiovascular Center
Division name Department of Stroke and Cerebrovascular Diseases
Zip code 564-8565
Address 6-1 Kishibe-Shimmachi, Suita, Osaka, Japan
TEL 06-6170-1070
Email tanakat@hsp.ncvc.go.jp

Public contact
Name of contact person
1st name Tomotaka
Middle name
Last name Tanaka
Organization Department of Stroke and Cerebrovascular Diseases
Division name Department of Stroke and Cerebrovascular Diseases
Zip code 564-8565
Address 6-1 Kishibe-Shimmachi, Suita, Osaka, Japan
TEL 06-6170-1070
Homepage URL
Email tanakat@hsp.ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National Cerebral and Cardiovascular Center
Address 6-1 Kishibe-Shimmachi, Suita, Osaka, Japan
Tel 06-6170-1070
Email tanakat@hsp.ncvc.go.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 ・京都大学,運動異常生理学講座
・神戸市立医療センター中央市民病院,神経内科
・東京都健康長寿医療センター,神経内科
・中村記念病院,神経内科
・聖マリア病院 脳血管内科
・トヨタ記念病院 神経内科
・熊本済生会病院 神経内科
・独立行政法人国立病院機構 岡山医療センター 神経内科

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 29 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 No longer recruiting
Date of protocol fixation
2014 Year 11 Month 06 Day
Date of IRB
2018 Year 03 Month 30 Day
Anticipated trial start date
2014 Year 11 Month 10 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design:prospective observational cohort study
Study population:
Patients with post stroke seizures admitted to our department between November 2014 and December 2018.
Outcomes:
Information regarding recurrent seizure was collected through inspection of inpatient and outpatient records or telephone inquiry with the patients themselves or relatives: the seizure recurrence, efficacy and modifications of AEDs and neurological status are recorded.
The following demographic and clinical characteristics are collected from medical records: age, sex, previous stroke type, previous late seizures, traumatic brain injury, neurosurgical intervention, dementia, family history of epilepsy, smoking, drinking alcohol, and stroke risk factors. We also check blood test, MR image, SPECT, EEG.

Management information
Registered date
2015 Year 11 Month 26 Day
Last modified on
2019 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023027

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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