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

NCT07837466 | Not Yet Recruiting

• 1 other identifier: Biomarkers in Post-Stroke CI
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stroke; Post-Stroke Cognitive Impairment; Ischemic Stroke; Intracerebral Hemorrhage; Basal Ganglia Stroke

Keywords

Neutrophil-to-Lymphocyte Ratio (NLR); Globulin-to-Lymphocyte Ratio (GLR); C-Reactive Protein-to-Lymphocyte Ratio (CLR); Lymphocyte-to-Monocyte Ratio (LMR); Montreal Cognitive Assessment (MoCA); Systemic Inflammation; Basal Ganglia; Stroke Severity; NIHSS

Outcome Measures

Primary Outcomes (1)

• Incidence of Early Post-Stroke Cognitive Impairment (PSCI)

  Post-stroke cognitive impairment is determined using the Arabic-validated Montreal Cognitive Assessment (MoCA). The MoCA tests multiple cognitive domains (visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation), yielding a total score between 0 and 30, where higher scores indicate better cognitive performance. Early PSCI is defined as an education-adjusted MoCA score of less than 23 (\<23).

  3 months post-stroke

Study Arms (1)

Adults with Acute Basal Ganglionic Stroke

Adult patients aged 18 to 59 years presenting with a first-ever acute ischemic or primary hemorrhagic stroke involving the basal ganglia (confirmed by brain CT or MRI) and admitted within 72 hours of symptom onset. Participants undergo baseline neurological assessment, stroke severity scoring via the National Institutes of Health Stroke Scale (NIHSS), and venous blood sampling between 24 and 72 hours post-admission to evaluate circulating immune-inflammatory biomarkers (neutrophil-to-lymphocyte ratio \[NLR\], globulin-to-lymphocyte ratio \[GLR\], CRP-to-lymphocyte ratio \[CLR\], and lymphocyte-to-monocyte ratio \[LMR\]). Cognitive function is evaluated at 3 months post-stroke using the Arabic-validated Montreal Cognitive Assessment (MoCA) to determine the occurrence of post-stroke cognitive impairment.

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18 to 59 years presenting with a confirmed first-ever acute stroke (ischemic or primary intracerebral hemorrhage) with basal ganglionic involvement, admitted to the Stroke Unit of the Department of Neurology at Assiut University Hospitals within 72 hours of symptom onset.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Neurology and Psychiatry

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09