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Not Yet Recruiting NCT07837466

Immune-Inflammatory Biomarkers in Predicting Early Cognitive Impairment in Adults With Acute Basal Ganglionic Stroke

Conditions: Stroke, Post-Stroke Cognitive Impairment, Ischemic Stroke, Intracerebral Hemorrhage, Basal Ganglia Stroke

Sex: All
Ages: 18 Years – 59 Years
Enrollment: 100
Sponsor: Assiut University

Summary

Post-stroke cognitive impairment (PSCI) is a common and disabling complication that affects memory, thinking, and daily functioning after a stroke. The immune-inflammatory response triggered during an acute stroke is believed to contribute to secondary brain injury and cognitive decline. Routine, low-cost blood tests that assess systemic inflammation, specifically the neutrophil-to-lymphocyte ratio (NLR), globulin-to-lymphocyte ratio (GLR), C-reactive protein-to-lymphocyte ratio (CLR), and lymphocyte-to-monocyte ratio (LMR), may serve as useful early indicators of cognitive risk. The purpose of this observational study is to evaluate whether these inflammatory blood markers, measured during the acute hospital phase, can independently predict early-onset cognitive impairment in adult patients aged 18 to 59 years with acute basal ganglionic stroke (ischemic or primary hemorrhagic). Participants admitted within 72 hours of symptom onset will undergo standard clinical assessments, stroke severity evaluation using the National Institutes of Health Stroke Scale (NIHSS), brain neuroimaging (CT or MRI), and routine blood testing between 24 and 72 hours post-admission. At 3 months post-stroke, participants will complete a cognitive evaluation using the Arabic-validated Montreal Cognitive Assessment (MoCA). Identifying accessible admission biomarkers could help healthcare providers recognize patients at high risk of cognitive impairment early, enabling timely monitoring and early referral for cognitive rehabilitation.

Eligibility Criteria

Inclusion Criteria: * Age between 18 and 59 years. * First-ever acute stroke (ischemic or primary intracerebral hemorrhage) confirmed by brain CT or MRI, with documented basal ganglionic involvement. * Hospital admission within 72 hours of symptom onset. * Written informed consent provided by the patient or their legally authorized representative. Exclusion Criteria: * Pre-existing cognitive impairment or dementia (e.g., Alzheimer's disease, vascular dementia). * Severe neurological or sensory deficits precluding cognitive assessment, including severe aphasia, altered level of consciousness, or significant visual or hearing impairment. * Severe organ dysfunction, including severe cardiac, hepatic, or renal insufficiency. * Medical conditions confounding systemic inflammatory markers, including active systemic infection, autoimmune disease, or recent major surgery/trauma. * Current or recent treatment with immunosuppressive drugs, systemic corticosteroids, or high-dose antibiotics.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07837466). StuddyBuddy aggregates publicly available trial information.