UMIN-CTR Clinical Trial

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

Post stroke seizure

Classification by specialty

Neurology

Emergency medicine

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

recurrence of post stroke seizure

Key secondary outcomes

compliance of antiepileptic drugs

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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 one 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

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

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

Institute

National Cerebral and Cardiovascular Center

Institute

Department

Personal name

Organization

National Cerebral and Cardiovascular Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2015

Year

11

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Study design:prospective observational cohort study
Study population:
Patients with post stroke seizures admitted to our department between November 2014 and September 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.

Registered date

2015

Year

11

Month

26

Day

Last modified on

2020

Year

01

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023027