Early Neuropsychological Rehabilitation and Family Psychoeducation After Ischemic Stroke

Cognitive impairment and reduced quality of life are frequent consequences of ischemic stroke and can also affect family caregivers, who often assume caregiving responsibilities with limited preparation. Evidence regarding rehabilitation interventions initiated during the early poststroke period remains limited. This randomized clinical trial evaluates two independent interventions initiated after baseline assessment and randomization, approximately 20 days after the index stroke: a structured computerized neuropsychological rehabilitation program for the patient and a structured psychoeducational program for the primary family caregiver. A 2×2 factorial design allows the main effect of each intervention to be estimated within a single sample and permits an exploratory assessment of their interaction. The primary outcome is quality of life at 3 months after stroke, measured using the CAVIDACE total direct score and completed by a family informant. Secondary outcomes include cognitive performance, functional status, mood, and caregiver burden. Molecular biomarkers and acute structural neuroimaging variables are examined as exploratory outcomes.

Inclusion Criteria: * First-ever ischemic stroke, excluding transient ischemic attack * Age 18 years or older * Inclusion within 96 hours of symptom onset * Functional independence before the index stroke, defined as a prestroke Modified Rankin Scale score ≤1 * Diagnosis of ischemic stroke classified according to the Oxfordshire Community Stroke Project as total anterior circulation infarction, partial anterior circulation infarction, posterior circulation infarction, or lacunar infarction * Capacity to provide written informed consent at enrollment or, in cases of temporary incapacity, availability of a legally authorized representative to provide consent on the participant's behalf, followed by participant re-consent if decision-making capacity is regained Exclusion Criteria: * Previous neurological or psychiatric disease associated with cognitive impairment * Severe systemic disease * Life expectancy of less than 1 year * Severe stroke, defined as a National Institutes of Health Stroke Scale score \>19 at admission * Alcohol or other substance abuse, excluding tobacco use * Clinically relevant aphasia preventing comprehension of neuropsychological test instructions, operationalized as a score \