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Recruiting NCT06984965

Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke

— Observational Acute Ischemic Stroke Acute Haemorrhagic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Ischemic Stroke, Acute Haemorrhagic Stroke. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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).

Primary outcome measures

  • Proportion of Participants With Focal Slowing in the Stroke-Affected Hemisphere [Time frame: Baseline (within 72 hours of stroke onset)]
  • Proportion of Participants With Interhemispheric Asymmetry in EEG Waveforms [Time frame: Baseline (within 72 hours of stroke onset)]
  • Proportion of Participants With Absent or Diminished EEG Reactivity [Time frame: Baseline (within 72 hours of stroke onset)]
  • Proportion of Participants With Epileptiform Activity on EEG [Time frame: Baseline (within 72 hours of stroke onset)]
Secondary outcome measures (2)
  • Correlation Between Baseline EEG Findings and Functional Recovery [Time frame: 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 [Time frame: Phase I (Baseline EEG assessment) and Phase III (3 to 6 month follow-up functional evaluation)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Neurology Department, Faculty of Medicine, Assiut University — Asyut

Identifiers

NCT: NCT06984965 · 04-2024-200998

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗