NCT07190976

Brief Summary

Τhe aim of the study is to investigate the role of EEG both in predicting epileptogenesis in patients with acute stroke and in detecting and clarifying the clinical significance of subclinical epileptic seizures in a stroke unit. More specifically, the performance of routine EEG in patients with ischemic or hemorrhagic stroke who are hospitalized in the Stroke Unit within the first days after the event, regardless of the presence of clinical indications, and the identification of risk factors for the early development of epilepsy in the course of these patients' disease constitute the central research question. The identification of patients with subclinical electroencephalographic seizures and the impact of such events on functional outcome, as well as their association with the development of epilepsy, are set as secondary research objectives.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Mar 2024Sep 2026

Study Start

First participant enrolled

March 1, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 24, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

2.6 years

First QC Date

September 17, 2025

Last Update Submit

September 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of post-stroke epilepsy

    4 years

Study Arms (1)

Adult patients with acute ischemic or hemorrhagic stroke

Other: Routine EEG

Interventions

The study is observational. No intervention is anticipated. Patients will be submitted to EEG recording within the first seven days of stroke

Adult patients with acute ischemic or hemorrhagic stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with acute ischemic or hemorrhagic stroke in whom it is not possible to perform an electroencephalogram within the first 7 days after the event, as well as patients who themselves or their legal representatives do not consent to participation, will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University General Hospital "ATTIKON"- General Hospital of West Attica "H AGIA VARVARA" 2nd Neurology Clinic, NKUA

Chaïdári, Athens, 12462, Greece

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Panagiota Eleni Tsalouchidou

Study Record Dates

First Submitted

September 17, 2025

First Posted

September 24, 2025

Study Start

March 1, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

September 24, 2025

Record last verified: 2025-09

Locations