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Идёт набор NCT06984965

Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke

— Наблюдательное Acute Ischemic Stroke Acute Haemorrhagic Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Acute Ischemic Stroke, Acute Haemorrhagic Stroke. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Официальное название

Role of Electroencephalogram (EEG) in Differentiation Between Ischemic and Hemorrhagic Stroke and as a Predictor of Post-stroke Recovery

Обзор

Searching electrical activity registered by EEG in acute ischemic and hemorrhagic stroke and comparing these parameters to the poststroke recovery patterns to investigate the role of EEG as a differentiation tool and as a predictor of post-stroke recovery.

Подробное описание

In this study, EEG will be performed on each patient included; within 72 hours of the onset of the stroke. The EEG device will be used within the intended use as described in the user manuals. The electrodes are put on the patient's head, and the EEG signal is recorded for several minutes; the amplifier is used to amplify the EEG signal and reduce artifacts. A complete EEG and data will be collected at baseline and on follow-up to observe the differences in EEG patterns to perform a qualitative assessment of the EEG results.

EEG patterns depend on the size and location of acute ischemic stroke, including generalized or focal slowing or both and epileptiform discharges. Abnormal neuronal activity is determined by comparing a part of the patient's brain not affected by stroke to a part of the patient's brain affected by stroke. Moreover, Abnormal blood flow is interpreted by comparing the abnormal EEG patterns in the areas of infarctions or hemorrhage to the normal brain tissue signals. The aim is to compare electric waveforms from an EEG device between patients with acute ischemic and acute hemorrhagic stroke (at baseline which is within 72 hours of the onset of acute ischemic and acute hemorrhagic stroke and through study completion, an average of 3 to 6 months).

Первичные конечные точки

  • Proportion of Participants With Focal Slowing in the Stroke-Affected Hemisphere [Срок оценки: Baseline (within 72 hours of stroke onset)]
  • Proportion of Participants With Interhemispheric Asymmetry in EEG Waveforms [Срок оценки: Baseline (within 72 hours of stroke onset)]
  • Proportion of Participants With Absent or Diminished EEG Reactivity [Срок оценки: Baseline (within 72 hours of stroke onset)]
  • Proportion of Participants With Epileptiform Activity on EEG [Срок оценки: Baseline (within 72 hours of stroke onset)]
Вторичные конечные точки (2)
  • Correlation Between Baseline EEG Findings and Functional Recovery [Срок оценки: Phase I (Baseline EEG assessment) and Phase III (3 to 6 month follow-up functional evaluation)]
  • Prediction of Post-Stroke Seizures Based on EEG Findings [Срок оценки: Phase I (Baseline EEG assessment) and Phase III (3 to 6 month follow-up functional evaluation)]

Критерии участия

Критерии включения

  • Age above 18 and below 80 years.
  • Acute Ischemic stroke: ischemic arteria cerebri media infarct confirmed by MRI.
  • Acute Hemorrhagic stroke: spontaneous intraparenchymal bleeding confirmed by CT.
  • Stroke onset <72 hours before expected time of performing EEG.
  • First-ever ischemic stroke.
  • Measurable deficit on the National Institute of Health Stroke Scale (NIHSS).
  • Able to give and sign informed consent.

Критерии исключения

  • Transient Ischemic Attacks (TIAs).
  • Greater than 72 hours past the initial insult.
  • Patients with subarachnoid haemorrhage, traumatic haemorrhage (epidural/subdural bleeding), cerebral venous sinus thrombosis, indication for urgent neurosurgical intervention.
  • History of other central nervous system diseases.
  • Any signs unfit for MRI/EEG scan.
  • Injury or active infection of electrode cap placement area.
  • Claustrophobia; recognition disorder.
  • Known skull defect or head trauma.
  • Previous neurological procedure (metallic implant, brain pace, cranial operation history).
  • Significant physical impairment that would restrict the ability to use the portable EEG devices.
  • Presence of malignancy or systemic rheumatic disease
  • Non-stroke disease or lesion affecting the sensorimotor system.
  • Alcohol or drug addiction.
  • Presence of pump/shunt.
  • Presence of Malignancy.
  • Presence of severe cognitive impairment.
  • History of epilepsy or taking medication due to epilepsy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Египет · 1 центр
  • Neurology Department, Faculty of Medicine, Assiut University — Asyut

Идентификаторы

NCT: NCT06984965 · 04-2024-200998

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗