Abstract
INTRODUCTION: Risk of cognitive decline following epilepsy surgery can be a significant barrier for patients pursuing surgery, and post-surgical cognitive changes can impact quality of life (QOL), surgical satisfaction and functional independence. Readiness Brain Operation Optimization Training (ReBOOT) is a virtual cognitive prehabilitation intervention that provides patients with psychoeducation and cognitive strategies prior to surgery to increase pre-surgical preparedness and post-surgical functional independence in the circumstance that a patient experiences cognitive decline after surgery. The primary aim of this feasibility trial is to evaluate the acceptability, adherence and procedural feasibility of implementing ReBOOT in patients being evaluated for epilepsy surgery. Secondary, explorative objectives include examining preliminary trends in QOL, compensatory strategy use, cognitive function and psychosocial outcomes to inform a future definitive trial. METHODS AND ANALYSIS: This is a single-centre, parallel-group, feasibility randomised controlled trial of a standardised cognitive prehabilitation programme for patients who are considering epilepsy surgery. Participants are randomly assigned to intervention (n=32) or control groups (n=32). The intervention group is enrolled in ReBOOT, a virtual programme that includes two 1-hour individual sessions and four 1-hour group sessions. Feasibility outcomes include attendance, homework adherence, attrition and participant satisfaction for participants randomised to the intervention group. Exploratory analyses will use longitudinal linear mixed-effects models to describe trends in exploratory outcomes over time. Data will be used to refine procedures and estimate parameters (eg, effect sizes and variance) for a future fully powered trial. ETHICS AND DISSEMINATION: Cleveland Clinic Institutional Review Board approved the study protocol, which is publicly available and registered on the National Institutes of Health ClinicalTrials.gov (NCT05992402) site. Results will be disseminated through conference presentations and academic publications, as well as shared with outside study sponsors (Society for Clinical Neuropsychology-Division 40 of the American Psychological Association; American Epilepsy Society). TRIAL REGISTRATION NUMBER: NCT05992402.