StrokePOSTER-1NCT03848273
Post Stroke Epileptic Seizures Risk Forecast
An observational study of Stroke and Post Stroke Seizure, run by Lviv National Medical University at 1 site in Ukraine.
Trial summary
Improve the effectiveness of treatment and prognosis in patients with cerebrovascular accident by early detection of the risk of developing epileptic seizures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Post Stroke Seizure, Post Stroke Epilepsy
- How many people
- 120 participants
- Where
- 1 siteUkraine
- Study dates
- 20 Feb 2019to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient of Lviv Clinical Emergency Hospital
Who may be able to join
- informed consent to participate in the study signed by the patient / relative of the patient / the legal representative of the patient
- age over 18 years
- stroke, confirmed by neuroimaging
- light to moderate stroke (score on National Institutes of Health Stroke Scale).
Who cannot join
- recanalization therapy
- previous epileptic seizures and history of epilepsy
- psychiatric diseases in history
- previous stroke
- traumatic brain injury
- brain tumors.
Show all 9Show fewer
- inflammatory and infectious diseases
- decompensated physical illness.
- pregnancy.
Trial locations and contacts
1 site in 1 country.
Ukraine1 site, 1 recruiting
- Recruiting
Danylo Halytsky Lviv National Medical University
Lviv, 79010
Andriy Kuzminskyy, M.D., +380973192791, a.kuzminskyy@gmail.com
About this study
Official title: Clinical Diagnostic Criteria of Forecasting Epileptic Seizures in Stroke Patients
Improve the effectiveness of treatment and prognosis in patients with cerebrovascular accident by early detection of the risk of developing epileptic seizures.
- Conditions
- Stroke, Post Stroke Seizure, Post Stroke Epilepsy
- Keywords
- stroke, epilepsy, seizure, EEG
- Medical subject headings
- Stroke, Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic | questionnaire, physical-neurological examination, labor investigations, EEG | |
| Hemorrhagic | questionnaire, physical-neurological examination, labor investigations, EEG | |
| Control | questionnaire, physical-neurological examination, labor investigations, EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
First epileptic seizure
Patient's dairy will be used to assess this outcome measure.
Measured: 1 year
Secondary outcomes (1)
Longest seizure-free period
Patient's dairy will be used to assess this outcome measure.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start20 Feb 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lviv National Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andriy Kuzminskyy, Lviv National Medical University
- Investigators
- Anzhelika Payenok, MD, DrMedSc, Prof, Study chair, Danylo Halytsky Lviv National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848273
- Sponsor's protocol ID
- LNMU-FPGE-Neuro-POSTER-1
- Acronym
- POSTER-1
- Status last verified
- Feb 2019
- First submitted
- 23 Jan 2019
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Diagnostic Criteria of Forecasting Epileptic Seizures in Stroke Patients
- ClinicalTrials.gov ID
- NCT03848273
- Acronym / sponsor ID
- POSTER-1 / LNMU-FPGE-Neuro-POSTER-1
- Conditions
- Stroke, Post Stroke Seizure, Post Stroke Epilepsy
- Keywords
- stroke, epilepsy, seizure, EEG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Lviv National Medical UniversityUniversity, hospital or other
- Study start
- 20 Feb 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Improve the effectiveness of treatment and prognosis in patients with cerebrovascular accident by early detection of the risk of developing epileptic seizures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ischemic | – | –questionnaire, physical-neurological examination, labor investigations, EEG |
| Hemorrhagic | – | –questionnaire, physical-neurological examination, labor investigations, EEG |
| Control | – | –questionnaire, physical-neurological examination, labor investigations, EEG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient of Lviv Clinical Emergency Hospital
Key inclusion criteria (4 listed)
- informed consent to participate in the study signed by the patient / relative of the patient / the legal representative of the patient
- age over 18 years
- stroke, confirmed by neuroimaging
- light to moderate stroke (score on National Institutes of Health Stroke Scale).
Key exclusion criteria (9 listed)
- recanalization therapy
- previous epileptic seizures and history of epilepsy
- psychiatric diseases in history
- previous stroke
- traumatic brain injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
First epileptic seizure
Time frame: 1 year
Patient's dairy will be used to assess this outcome measure.
1 secondary outcome
Longest seizure-free period
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anzhelika Payenok, MD, DrMedSc, Prof study chair
Danylo Halytsky Lviv National Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Post Stroke Seizure, run by Lviv National Medical University at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andriy Kuzminskyy, M.D. (+380973192791, a.kuzminskyy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First epileptic seizure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.