Benson Relaxation for Anxiety and Depression After Stroke
NCT07731282
Anxiety Disorders, Brain Diseases
Changchun, Jilin, China
View Trial DetailsNCT Number: NCT07235423
This prospective cohort study investigates predictors of post-stroke cognitive impairment (PSCI) in patients undergoing endovascular thrombectomy (EVT) for acute ischemic stroke due to large vessel occlusion. Adult patients with successful reperfusion (mTICI 2b-3) will be followed at 3 and 6 months to assess cognition, functional recovery, and depression. Predictors across clinical, procedural, radiological, and laboratory domains will be analyzed. The study aims to identify risk factors for PSCI, estimate its prevalence, and evaluate its impact on outcomes.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Post-stroke cognitive impairment (PSCI) is a major cause of long-term disability, affecting up to 40% of ischemic stroke survivors. Large vessel occlusion (LVO) strokes, often treated with endovascular thrombectomy (EVT), carry a particularly high risk of cognitive sequelae. While EVT has proven efficacy in improving functional outcomes, its effect on cognitive outcomes remains underexplored.
This prospective observational cohort study will enroll approximately 120 adult patients (≥18 years) with anterior circulation LVO undergoing EVT at Assiut University Hospital. Eligible participants must achieve successful reperfusion (mTICI 2b-3) and provide consent. Patients with severe aphasia, coma, pre-existing dementia, non-ischemic etiologies, or early death (within 72 hours) will be excluded.
Participants will undergo systematic assessment of cognitive function (MoCA-Arabic, Oxford Cognitive Screening if MoCA <26), functional status (mRS, Barthel Index), and mood (HADS-Arabic) at baseline, 3 months, and 6 months. Clinical data (demographics, vascular risk factors, NIHSS, time metrics), procedural details (technique, procedure time, number of passes, anesthesia type, hemodynamic stability, complications), radiological parameters (infarct site and volume, ASPECTS, WMH by Fazekas score, cortical atrophy, microbleeds), and laboratory markers (CRP, ESR, lipid profile, HbA1C, uric acid, D-dimer, CBC) will be collected.
The primary objective is to identify predictors of PSCI at 3-6 months after thrombectomy. Secondary objectives include estimating the prevalence of PSCI in this population and analyzing its association with functional outcomes and depression. Statistical analysis will include univariate and multivariate regression models adjusting for potential confounders such as age, education, and infarct volume.
Ethical approval has been obtained from the Faculty of Medicine, Assiut University Ethics Committee. Written informed consent will be obtained from all participants, and confidentiality will be strictly maintained.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy
Cognitive status will be assessed using the Arabic version of the Montreal Cognitive Assessment (MoCA, score range 0-30, with scores <26 indicating impairment). The primary outcome will be the prevalence of post-stroke cognitive impairment (PSCI) among thrombectomy patients.
Time frame: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy
For participants scoring <26 on MoCA, the Oxford Cognitive Screen (OCS) will be administered to evaluate specific domains of cognition (attention, executive function, memory, language, visuospatial ability).
Time frame: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy
Psychological status will be measured using the Hospital Anxiety and Depression Scale (HADS, score range 0-21 per subscale). Outcomes will include mean scores and prevalence of clinically significant symptoms.
Time frame: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy
Functional status will be assessed using the Barthel Index (score range 0-100). Higher scores indicate greater independence in activities of daily living.
Time frame: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy
Global disability will be measured using the modified Rankin Scale (mRS, score range 0-6, with 0 indicating no symptoms and 6 indicating death).
Time frame: Within 24-72 hours post-thrombectomy
Infarct size will be quantified using diffusion-weighted MRI, measured in milliliters.
Time frame: Within 24-72 hours post-thrombectomy
White matter disease burden will be assessed using the Fazekas score (0-3 scale) on FLAIR MRI
Time frame: Within 24-72 hours post-thrombectomy
C-reactive protein (CRP, mg/L)
Time frame: Within 24-72 hours post-thrombectomy
lipid profile (mg/dL)
Time frame: Within 24-72 hours post-thrombectomy
D-dimer (µg/mL)
Contact information is provided by the study sponsor or research team.
Assiut University
Other
Predictors of Post-Thrombectomy Cognitive Impairment in Acute Ischemic Stroke Patients : a Prospective Cohort Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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