Post Stroke Epileptic Seizures Risk Forecast (POSTER-1)

February 19, 2019 updated by: Andriy Kuzminskyy, Lviv National Medical University

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
      • Lviv, Ukraine, 79010
        • Recruiting
        • Danylo Halytsky Lviv National Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient of Lviv Clinical Emergency Hospital

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • recanalization therapy
  • previous epileptic seizures and history of epilepsy
  • psychiatric diseases in history
  • previous stroke
  • traumatic brain injury
  • brain tumors.
  • inflammatory and infectious diseases
  • decompensated physical illness.
  • pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First epileptic seizure
Time Frame: 1 year
Patient's dairy will be used to assess this outcome measure.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Longest seizure-free period
Time Frame: 1 year
Patient's dairy will be used to assess this outcome measure.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 1 year
Coroner report will be used to assess this outcome measure.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lviv National Medical University

Investigators

  • Study Chair: Anzhelika Payenok, MD, DrMedSc, Prof, Danylo Halytsky Lviv National Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 20, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

August 31, 2022

Study Registration Dates

First Submitted

January 23, 2019

First Submitted That Met QC Criteria

February 19, 2019

First Posted (Actual)

February 20, 2019

Study Record Updates

Last Update Posted (Actual)

February 20, 2019

Last Update Submitted That Met QC Criteria

February 19, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LNMU-FPGE-Neuro-POSTER-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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