StrokeNCT07837466
Immune-Inflammatory Biomarkers in Predicting Early Cognitive Impairment in Adults With Acute Basal Ganglionic Stroke
An observational study of Stroke and Post-Stroke Cognitive Impairment, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Stroke, Post-Stroke Cognitive Impairment, Ischemic Stroke
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Role of Immune-Inflammatory Biomarkers in Predicting Early Cognitive Impairment in Adults With Acute Basal Ganglionic Stroke
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
- Medical subject headings
- Stroke, Ischemic Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hassan Hammad Abd Albadeaa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837466
- Sponsor's protocol ID
- Biomarkers in Post-Stroke CI
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Immune-Inflammatory Biomarkers in Predicting Early Cognitive Impairment in Adults With Acute Basal Ganglionic Stroke
- ClinicalTrials.gov ID
- NCT07837466
- Acronym / sponsor ID
- Biomarkers in Post-Stroke CI
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Early Post-Stroke Cognitive Impairment (PSCI)
Time frame: 3 months post-stroke
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Post-Stroke Cognitive Impairment, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Early Post-Stroke Cognitive Impairment (PSCI) (time frame: 3 months post-stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.