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NCT Number: NCT05864547

Predisposing Factors for Post-stroke Epilepsy

The goal of this observational study is to learn about epilepsy after a stroke (post-stroke epilepsy). The main questions it aims to answer are:

* What make some patients develop epilepsy after a stroke? * Does sleep have an impact on the development of post-stroke epilepsy?

Participants will undergo:

* Electroencephalography (EEG) * Magnetic resonance imaging (MRI) * Polysomnography (only patients)

Blood tests will also be taken. The patient group will be compared to the healthy controls. Researchers will also look into medical records of stroke patients hospitalized at St. Olavs hospital and collect relevant information.

Recruiting

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Key information

Conditions

Post Stroke Epilepsy Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Epilepsy Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Olavs Hospital Stroke Unit

Trondheim, Norway

Location status: Recruiting

Location contact

Hanne Ellekjær, PhD

CONTACT

[email protected]

+47 72575494

About this study

This study aims to study risk factors and clinical factors which might contribute to the development of post-stroke epilepsy. Researchers will look at the volume and size of the stroke-induced brain lesions and analyze inflammation markers. Patients and controls will undergo EEG and MRI. The correlations between sleep and epilepsy after a stroke will also be investigated through polysomnography. Relevant information about for instance age, comorbidities and NIHSS will be collected. Researchers will also collect relevant information from medical records of stroke patients hospitalized at St. Olavs hospital.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First time stroke patients with capacity to consent, admitted to the stroke unit at St. Olavs hospital.
  • Modified Rankin Scale (mRS) ≤ 2 before the stroke

Exclusion criteria

  • Previous stroke or brain surgery
  • Traumatic brain injuries
  • Neurodegenerative diseases
  • Brain tumors
  • Epilepsy before the stroke
  • Hydrocephalus
  • Aphasia
  • Serious psychiatric disorders
  • MRI incompatibility and claustrophobia

Treatment and study plan

Primary outcomes

  1. Post-stroke epilepsy

    Time frame: 6 months

    Minimum one documented case of post-stroke epilepsy after the stroke

Secondary outcomes

  1. Acute symptomatic seizure

    Time frame: 14 days

    Minimum one documented case of acute symptomatic seizure with epileptogenic activity recorded with EEG

Study contacts

Contact information is provided by the study sponsor or research team.

Axel Sandvig, PhD prof

CONTACT

[email protected]

+47 47333042

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Acronym: PRESTEP

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
May 18, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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