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This study primarily evaluates whether iEV nasal administration can improve neurological impairment and cognitive dysfunction in patients with acute cerebral infarction and cognitive impairment, and preliminarily explores its clinical efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSCI+iEV | Experimental | Intranasal administration of iEV, twice a week, 2 ml each time (at a concentration of 2×10¹⁰/ml), for 12 consecutive weeks. |
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| PSCI+Control | Placebo Comparator | Control |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iEV | Biological | Intranasal administration of iEV, twice a week, 2 ml each time (at a concentration of 2×10¹⁰/ml), for 12 consecutive weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| NIHSS | The **National Institutes of Health Stroke Scale (NIHSS)** is a standardized, 11-item assessment tool used to quantify the severity of neurological deficits in patients with acute stroke. Designed to provide objective measurements, it evaluates key domains including level of consciousness (alertness, orientation, and ability to follow commands), gaze, visual fields, facial palsy, motor strength in arms and legs, limb ataxia, sensory function, language (ability to comprehend and express), dysarthria (speech clarity), and extinction/inattention (neglect of sensory or motor stimuli). Each item is scored from 0 (no deficit) to a maximum of 2, 3, or 4 points, depending on the domain, with total scores ranging from 0 (no neurological impairment) to 42 (severe impairment). Widely used in clinical practice, emergency care, and research, the NIHSS helps guide treatment decisions (such as eligibility for thrombolysis or thrombectomy), track neurological changes over time, and predict patient ou | From enrollment to the end of treatment at 12 weeks |
| mRS | The **Modified Rankin Scale (mRS)** is a widely used, standardized tool to assess functional outcome and disability in patients following neurological events, most commonly stroke. Ranging from 0 to 6, it categorizes a patient's level of independence in daily activities based on their ability to perform tasks without assistance. A score of 0 indicates no symptoms or disability, while 1 reflects minor symptoms with no functional impairment. Scores of 2 and 3 denote mild to moderate disability, where patients require some help but can walk unassisted (2) or need significant assistance and may have difficulty walking (3). A score of 4 indicates severe disability, with patients unable to walk or attend to their own bodily needs without constant care. A score of 5 represents complete dependence on others for all aspects of daily living, and 6 signifies death. The mRS is valued for its simplicity, clinical relevance, and ability to track recovery over time, making it essential for guiding p | From enrollment to the end of treatment at 12 weeks |
| ADL | The **Activities of Daily Living (ADL) scale** is a standardized assessment tool used to evaluate an individual's ability to perform essential self-care and daily tasks independently. Focused on functional capacity, it typically includes key activities such as bathing, dressing, grooming, toileting, feeding, transferring (e.g., moving from bed to chair), and maintaining continence. Scoring systems vary slightly across versions (e.g., Barthel Index, Katz Index), but most rate each activity on a scale reflecting independence (e.g., "able to perform without help") to dependence (e.g., "requires full assistance" or "unable to perform"). Total scores quantify the level of functional impairment, with higher scores indicating greater independence and lower scores signaling increased reliance on others. Widely used in healthcare settings-particularly for patients with stroke, dementia, or chronic illness-the ADL scale helps guide care planning, assess recovery progress, determine long-term ca |
| Measure | Description | Time Frame |
|---|---|---|
| Indicators of pro-inflammatory factors | Changes in indicators of pro-inflammatory factors (including IL-6, IL-1β, TGF-β). | From enrollment to the end of treatment at 12 weeks |
| Indicators of blood-brain barrier disruption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongmei Wang, Dr. | Contact | +862164369181 | 2272454068@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Sixth People's Hospital | Recruiting | Shanghai | 200000 | China |
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| Basic treatments | Other | Basic treatments for cerebrovascular diseases such as antiplatelet aggregation, blood pressure control, blood glucose control, blood lipid control, and plaque stabilization. |
|
| From enrollment to the end of treatment at 12 weeks |
| MoCA | The **Montreal Cognitive Assessment (MoCA)** is a brief, standardized tool designed to screen for mild cognitive impairment and detect early signs of cognitive decline, often used in clinical settings to evaluate individuals at risk for conditions like Alzheimer's disease or vascular dementia. Comprising 30 points across multiple cognitive domains, it assesses attention and concentration, executive functions (e.g., planning, problem-solving), memory (immediate and delayed recall), language (naming, fluency, comprehension), visuospatial abilities (e.g., copying a complex figure), calculation, and orientation to time and place. Each task is scored based on performance, with points deducted for errors or incomplete responses. A total score of 26 or higher is generally considered normal, while scores below 26 indicate varying degrees of cognitive impairment, with lower scores reflecting more significant deficits. Valued for its sensitivity to mild impairments-often missed by simpler tools | From enrollment to the end of treatment at 12 weeks |
| MMSE | The **Mini-Mental State Examination (MMSE)** is a widely used, brief screening tool designed to assess global cognitive function, primarily to detect cognitive impairment or dementia. Consisting of 30 points, it evaluates key cognitive domains including orientation to time and place (e.g., identifying the current date, season, or location), registration (remembering a list of words), attention and calculation (e.g., serial subtraction or spelling backward), recall (retrieving the earlier list of words), language (naming objects, following commands, writing a sentence, or copying a design), and comprehension. Each task is scored based on accuracy or completion, with points awarded for correct responses. A total score of 27-30 is typically considered within the normal range, 21-26 indicates mild impairment, 10-20 reflects moderate impairment, and scores below 10 signify severe cognitive decline. While valued for its simplicity and widespread use in clinical and research settings, the MM | From enrollment to the end of treatment at 12 weeks |
Changes in indicators of blood-brain barrier disruption(VE-cadherin、Claudin-5、ZO-1).
| From enrollment to the end of treatment at 12 weeks |
| Indicators of neuronal injury | Changes in indicators of neuronal injury (NSE, S100β, TDP-43, BDNF, GFAP). | From enrollment to the end of treatment at 12 weeks |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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