Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 14, 2025
Date Accepted: Nov 7, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Cognitive recovery after post-stroke delirium [RECOVER]: methodological approach for a repeated multimodal cognitive assessment in stroke patients
ABSTRACT
Background:
Post-stroke delirium (PSD) is a severe complication in acute stroke patients and is characterized by rapid onset fluctuating symptoms, which affect multiple domains (cognition, motor system, sleep-wake cycle). Similar to other types of delirium, PSD is associated with longer hospitalization, higher mortality and a higher disability rate. Behavioral studies on cognitive functioning showed significantly poorer cognitive outcomes in both PSD and non-PSD stroke patients compared to healthy controls. Thus, the distinction between “stroke-related” and “PSD-related” cognitive impairments remains unclear. A frequently affected and highly disabling cognitive domain are memory functions. However, imaging studies, particularly task-based functional MRI studies on PSD, are currently scarce and represent a significant gap in the existing literature.
Objective:
This longitudinal proof-of-concept study aims to investigate the short- and long-term effects of stroke and PSD on cognitive outcome using a multimodal approach and to outline a protocol for a repeated multimodal cognitive assessment in stroke patients.
Methods:
We developed a longitudinal study protocol to investigate short- and long-term effects of stroke and PSD on cognitive impairment and recovery. Post-stroke cognitive functioning (PSCF) will be assessed in a comprehensive digital multimodal approach including a multi-domain neuropsychological app to facilitate a standardized, rapid testing, particularly for long-term outcomes, as well as tasked-based functional MRI (introducing a modified working memory task) during the acute (prior PSD development) and post-acute phase post-stroke and at 3-month follow-up. In total 40 acute stroke patients, divided into a PSD group and non-PSD group (control) will be examined. In the context of the proof-of-concept study, the eligibility of a modified working-memory task, an app-based neuropsychological assessment, and a multimodal MRI protocol will be evaluated. The primary endpoint is a between-group comparison of the cognitive outcome, defined as global PSCF at 3-months follow-up. Global PSCF will be classified as normal cognitive functioning, or mild, moderate or severe cognitive impairment, according to the performance level (norm-referenced z-scores) on a multi-domain neuropsychological assessment.
Results:
n/a
Conclusions:
This study protocol provides a comprehensive multimodal assessment for investigating PSCF in PSD vs. non-PSD patients. Findings from this study, particularly those derived from a direct assessment of cognitive functions during fMRI, may contribute to a more comprehensive understanding of the contribution of PSD to long-term cognitive impairment after stroke. Clinical Trial: ClinicalTrials.gov: NCT06680336.
Citation
