Clinical trial NCT06984965: Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Official title: Role of Electroencephalogram (EEG) in Differentiation Between Ischemic and Hemorrhagic Stroke and as a Predictor of Post-stroke Recovery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Ischemic Stroke
Acute Haemorrhagic Stroke
Keywords: EEG
Acute Ischaemic Stroke
Acute Haemorrhagic Stroke
Stroke Recovery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute Ischemic stroke: ischemic arteria cerebri media infarct confirmed by MRI, or acute Hemorrhagic stroke: spontaneous intraparenchymal bleeding confirmed by CT, onset \<72 hours before expected time of performing EEG.

Brief summary: 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).

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.

Primary outcomes:
measure: Proportion of Participants With Focal Slowing in the Stroke-Affected Hemisphere
timeFrame: Baseline (within 72 hours of stroke onset)
measure: Proportion of Participants With Interhemispheric Asymmetry in EEG Waveforms
timeFrame: Baseline (within 72 hours of stroke onset)
measure: Proportion of Participants With Absent or Diminished EEG Reactivity
timeFrame: Baseline (within 72 hours of stroke onset)
measure: Proportion of Participants With Epileptiform Activity on EEG
timeFrame: Baseline (within 72 hours of stroke onset)
Secondary outcomes:
measure: Correlation Between Baseline EEG Findings and Functional Recovery
timeFrame: Phase I (Baseline EEG assessment) and Phase III (3 to 6 month follow-up functional evaluation)
measure: Prediction of Post-Stroke Seizures Based on EEG Findings
timeFrame: Phase I (Baseline EEG assessment) and Phase III (3 to 6 month follow-up functional evaluation)
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Neurology Department, Faculty of Medicine, Assiut University
Study officials:
References: