Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery

Study Overview
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Brief Summary
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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
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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 recruitment, 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 compensatory strategy use, psychosocial factors, and surgical expectations and 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.

Official Title
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Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery

Conditions
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Epilepsy

Intervention / Treatment
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* Behavioral: ReBOOT program


Participation Criteria
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Eligibility Criteria
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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 neurosurgery Willing and able to participate in cognitive intervention Exclusion Criteria: Patients with a history of non-epileptic or psychogenic seizures Any patient that has engaged in any form of cognitive rehabilitation/intervention within the last 6 months Pending litigation related to the cause of epilepsy or current application for long term disability 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants in this arm will receive 2 one-on-one virtual education sessions as well as 4 virtual group education sessions prior to their epilepsy surgery. | Behavioral: ReBOOT program<br>* This is a virtual cognitive intervention led by a clinical neuropsychologist. Participants will attend 2 one-on-one individual sessions and 4 group sessions prior to their epilepsy surgery. Groups will be made up of 3-10 participants. The intervention is designed to provide participants with information about possible changes and/or challenges they may experience after epilepsy surgery, as well as cognitive strategies to implement prior to surgery to increase effectiveness of compensation for any new cognitive difficulties that may be experienced following surgery.<br>|
| No Intervention: Treatment-as-Usual<br>Participants in this arm will not receive the education sessions and will receive standard epilepsy care prior to their surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment success | As determined by number of patients contacted vs enrolled | 5-6 Weeks post study enrollment | 
| Intervention attendance | As determined by weekly group attendance and the number of weeks it takes each patient to complete all four rotating sessions | 5-6 Weeks post study enrollment | 
| Rate of Homework Completion | As determined by self-reported whether or not patient attempted to complete or completed their homework | 5-6 Weeks post study enrollment | 
| Study Attrition | As determined by number of patients who do not complete the ReBOOT program and the reasons why | 5-6 Weeks post study enrollment | 
| Intervention Efficacy based on Functional Status - Based on The Instrumental Activities of Daily Living-Compensation questionnaire score | The Instrumental Activities of Daily Living-Compensation questionnaire (Min/Max: 27-216, higher score means worse outcome) | 5-6 weeks post study enrollment, 6 month, 12 month | 
| Intervention Efficacy based on Functional Status - Based on The Quality of Life in Epilepsy questionnaire score | Quality of Life in Epilepsy questionnaire (Min/Max: 0-100, higher score means better outcome) | 5-6 weeks post study enrollment, 6 month, 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Subjective Cognitive Function | 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) | 5-6 weeks post study enrollment, 6 month, 12 month | 
| Change in Stress | As assessed by the Perceived Stress Scale 4 (Min/Max: 0-16, higher score means worse outcome) | 5-6 weeks post study enrollment, 6 month, 12 month | 
| Change in Mood | 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) | 5-6 weeks post study enrollment, 6 month, 12 month | 
| Surgery Satisfaction assessed by Epilepsy Surgery Satisfaction Questionnaire | Min/Max: 19-133, higher score means better outcome | 6 month, 12 month |