Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery

Not Applicable

Recruiting

• Conditions: Epilepsy

• Registration Number: NCT05992402
• Lead Sponsor: Kayela Arrotta

Brief Summary

The goal of this clinical trial is to learn if new educational program prior to epilepsy surgery can either decrease the risk of cognitive decline after surgery or be a help to those patients who experience a decline after undergoing epilepsy surgery.

Participants will participate in 2 individual virtual sessions and 4 virtual group sessions over the course of 5-6 weeks prior to their epilepsy surgery. They will asked to fill out online surveys and questionnaires at various times throughout the study, up to 12 months after their surgery.

To see if the educational program works, researchers will compare those participating in the educational program with those that are receiving the standard epilepsy care prior to surgery.

Detailed Description

In this prospective, controlled, randomized study, the researchers aim to assess the feasibility and effectiveness of a cognitive intervention in those with epilepsy. They will implement a novel prehabilitation program for patients who have been recommended for epilepsy surgery and will track retention, and adherence to understand the feasibility of the program. Researchers will gather patient data regarding satisfaction with the prehabilitation program and elicit qualitative feedback from patients to further refine the program. To assess intervention efficacy, researchers will compare patients who undergo the prehabilitation program to a treatment-as-usual control group on outcome measures related to quality of life, compensatory strategy use, psychosocial factors, and surgical satisfaction.

The study team will accomplish these objectives by comparing participants that are randomly assigned to the ReBOOT intervention arm (2 individual, virtual sessions and 4 virtual, group sessions over the course of 5-6 weeks) to those participants assigned to the control arm (standard epilepsy care). Researchers will measure the effects and feasibility of the intervention through the use attendance tracking, homework adherence, and health and quality of life questionnaires.

Study Timeline

• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-08-07
• Study First Posted: 2023-08-15
• Study Start: 2023-12-06
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-29
• Last Update Posted: 2025-10-31
• Primary Completion: 2028-06
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Adults, aged 18-60 years old, with diagnosed epilepsy who have been confirmed as an appropriate surgical candidate by their epileptologist
• Able to independently provide informed consent
• Fluent in English
• Reading abilities at or above 8th grade level as determined by the Wide Range Achievement Test- 4th Edition (WRAT-4), Reading subtest.
• Internet access and the ability to participate in online video streaming
• No history of resective or ablative neurosurgery, but this does not include neuromodulation therapies for epilepsy (e.g., RNS, VNS, DBS)
• Willing and able to participate in cognitive intervention

Exclusion Criteria

• Any patient that has engaged in any form of cognitive rehabilitation/intervention within the last 6 months
• Ongoing litigation related to the cause of epilepsy, unless litigation is related to short term or long-term disability application.
• Undergoing intensive medical treatment for serious or life-threatening illness (e.g., chemotherapy, etc.) that would impact study participation.
• Serious psychiatric condition that could interfere with participation, such as schizophrenia, active psychosis, active mania, and current suicidal ideation.
• Significant hearing and/or vision loss that would preclude them from participating in remote cognitive testing and engaging in the cognitive intervention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Study Attrition	5-6 Weeks post study enrollment	As determined by number of patients who do not complete the ReBOOT program and the reasons why
Intervention attendance	5-6 Weeks post study enrollment	As determined by weekly group attendance and the number of weeks it takes each patient to complete all four rotating sessions
Rate of Homework Completion	5-6 Weeks post study enrollment	As determined by self-reported whether or not patient attempted to complete or completed their homework
Intervention Efficacy based on Quality of Life	5-6 weeks post study enrollment, 6 month, 12 month	As assessed by the Quality of Life in Epilepsy questionnaire (Min/Max: 0-100, higher score means better outcome)

Secondary Outcome Measures

Name	Time	Method
Change in Subjective Cognitive Function	5-6 weeks post study enrollment, 6 month, 12 month	As assessed by the Memory Assessment Clinics Scale for Epilepsy (Min/Max: 30-150, Higher score means better outcome) and the Everyday Compensation Scale (Min/Max: 0-220, higher score means better outcome)
Change in Stress	5-6 weeks post study enrollment, 6 month, 12 month	As assessed by the Perceived Stress Scale 4 (Min/Max: 0-16, higher score means worse outcome)
Change in Mood	5-6 weeks post study enrollment, 6 month, 12 month	As assessed by the Patient Health Questionnaire (Min/Max: 0-24, higher score means worse outcome) and the Generalized Anxiety Disorder (Min/Max: 0-21, higher score means worse outcome)
Surgery Satisfaction assessed by Epilepsy Surgery Satisfaction Questionnaire	6 month, 12 month	Min/Max: 19-133, higher score means better outcome
Intervention Efficacy based on Functional Status	5-6 weeks post study enrollment, 6 month, 12 month	As assessed by the Instrumental Activities of Daily Living-Compensation questionnaire (Min/Max: 27-216, higher score means worse outcome)
Satisfaction with ReBOOT	5-6 weeks post study enrollment	As assessed by the qualitative Satisfaction of ReBOOT questionnaire and qualitative feedback
Change in Self-Efficacy	5-6 weeks post study enrollment, 6 month, 12 month	As assessed by the General Self-Efficacy Scale questionnaire (Min/Max: 10-40, higher score means greater self-efficacy)
Change in Locus of Control	5-6 weeks post study enrollment, 6 month, 12 month	As assessed by the Multidimensional Health Locus of Control questionnaire (Min/Max: 24-144, higher score means greater locus of control)
Change in Word List Recall	Pre-surgery and 6 Months Post-surgery	As assessed by the Rey Auditory Verbal Learning Task (Min/Max: 50-150, Higher score means better outcome).
Change in Story Recall	Pre-surgery and 6 Months Post-surgery	As assessed by the Wechsler Memory Scale - 4th Edition Logical Memory (Min/Max: 1-19, Higher score means better outcome).
Change in Visual Memory Recall	Pre-surgery and 6 Months Post-surgery	As assessed by the Wechsler Memory Scale - 4th Edition Visual Reproductions (Min/Max: 1-19, Higher score means better outcome).
Change in Naming	Pre-surgery and 6 Months Post-surgery	As assessed by the Boston Naming Test (Min/Max: 0-60, Higher score means better outcome).
Change in Attention	Pre-surgery and 6 Months Post-surgery	As assessed by the Wechsler Adult Intelligence Scale - 4th Edition Digit Span (Min/Max: 1-19, Higher score means better outcome).
Change in Problem Solving	Pre-surgery and 6 Months Post-surgery	As assessed by the Wisconsin Card Sorting Test (Min/Max: 50-150, Higher score means better outcome).
Change in Mental Flexibility	Pre-surgery and 6 Months Post-surgery	As assessed by the Trail Making Test Part B (Min/Max: 20-80, Higher score means better outcome).

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States