- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06984965
- Original Trial
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Role of Electroencephalogram (EEG) in Differentiation Between Ischemic and Hemorrhagic Stroke and as a Predictor of Post-stroke Recovery
Study Overview
Status
Conditions
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).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Gena ELassall, Bachelor of medicine and gener
- Phone Number: +201028914897
- Email: genaelassall312@gmail.com
Study Locations
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Asyut, Egypt, 71511
- Recruiting
- Neurology Department, Faculty of Medicine, Assiut University
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Contact:
- Gena ELassall
- Phone Number: 01028914897
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Contact:
- Gena ELassall
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Ischaemic Stroke Group
Patients with ischemic arteria cerebri media infarct confirmed by MRI.
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Haemorrhagic Stroke Group
Patients with spontaneous intraparenchymal bleeding confirmed by CT.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Proportion of Participants With Focal Slowing in the Stroke-Affected Hemisphere
Time Frame: Baseline (within 72 hours of stroke onset)
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Presence of focal slowing (e.g., increased delta or theta activity) in the stroke-affected hemisphere versus the unaffected hemisphere.
Patterns categorized as "ischemic" or "hemorrhagic.";
this will be measured in percentage (%).
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Baseline (within 72 hours of stroke onset)
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Proportion of Participants With Interhemispheric Asymmetry in EEG Waveforms
Time Frame: Baseline (within 72 hours of stroke onset)
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Qualitative assessment of EEG asymmetry between affected and unaffected hemispheres at baseline.
Frequency of each will be measured in percentage (%).
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Baseline (within 72 hours of stroke onset)
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Proportion of Participants With Absent or Diminished EEG Reactivity
Time Frame: Baseline (within 72 hours of stroke onset)
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Absence or reduction in EEG reactivity to external stimuli (e.g., auditory, tactile) in the affected hemisphere; this will be measures by precentage (%).
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Baseline (within 72 hours of stroke onset)
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Proportion of Participants With Epileptiform Activity on EEG
Time Frame: Baseline (within 72 hours of stroke onset)
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Presence of epileptiform discharges (e.g., spikes or sharp waves) on EEG in the stroke-affected hemisphere; thsi will be measured by precentage (%).
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Baseline (within 72 hours of stroke onset)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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Association between initial qualitative EEG abnormalities (e.g., focal slowing, asymmetry) and functional outcomes measured by standardized scales (e.g., Modified Rankin Scale) at 6 months; measured by Correlation coefficient (r).
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Phase I (Baseline EEG assessment) and Phase III (3 to 6 month follow-up functional evaluation)
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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)
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Proportion of participants with specific EEG abnormalities (e.g., epileptiform activity) at baseline who develop post-stroke seizures within 3 to 6 months, measured by percentage (%).
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Phase I (Baseline EEG assessment) and Phase III (3 to 6 month follow-up functional evaluation)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-2024-200998
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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