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

October 29, 2025 updated by: Kayela Arrotta

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kayela Arrotta, PhD
  • Phone Number: 216-444-6101
  • Email: ArrottK@ccf.org

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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
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.
No Intervention: Treatment-as-Usual
Treatment as usual but will also receive three brief 5-minute phone calls over 6-weeks after initial enrollment. These phone calls are not therapeutic in nature but provide control participants with brief engagement in study-related activities to ensure that any benefits seen between groups are not simply attributable to study participation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention attendance
Time Frame: 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
5-6 Weeks post study enrollment
Study Attrition
Time Frame: 5-6 Weeks post study enrollment
As determined by number of patients who do not complete the ReBOOT program and the reasons why
5-6 Weeks post study enrollment
Rate of Homework Completion
Time Frame: 5-6 Weeks post study enrollment
As determined by self-reported whether or not patient attempted to complete or completed their homework
5-6 Weeks post study enrollment
Intervention Efficacy based on Quality of Life
Time Frame: 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)
5-6 weeks post study enrollment, 6 month, 12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Subjective Cognitive Function
Time Frame: 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)
5-6 weeks post study enrollment, 6 month, 12 month
Change in Stress
Time Frame: 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)
5-6 weeks post study enrollment, 6 month, 12 month
Change in Mood
Time Frame: 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)
5-6 weeks post study enrollment, 6 month, 12 month
Surgery Satisfaction assessed by Epilepsy Surgery Satisfaction Questionnaire
Time Frame: 6 month, 12 month
Min/Max: 19-133, higher score means better outcome
6 month, 12 month
Intervention Efficacy based on Functional Status
Time Frame: 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)
5-6 weeks post study enrollment, 6 month, 12 month
Satisfaction with ReBOOT
Time Frame: 5-6 weeks post study enrollment
As assessed by the qualitative Satisfaction of ReBOOT questionnaire and qualitative feedback
5-6 weeks post study enrollment
Change in Self-Efficacy
Time Frame: 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)
5-6 weeks post study enrollment, 6 month, 12 month
Change in Locus of Control
Time Frame: 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)
5-6 weeks post study enrollment, 6 month, 12 month
Change in Word List Recall
Time Frame: 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).
Pre-surgery and 6 Months Post-surgery
Change in Story Recall
Time Frame: 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).
Pre-surgery and 6 Months Post-surgery
Change in Visual Memory Recall
Time Frame: 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).
Pre-surgery and 6 Months Post-surgery
Change in Naming
Time Frame: Pre-surgery and 6 Months Post-surgery
As assessed by the Boston Naming Test (Min/Max: 0-60, Higher score means better outcome).
Pre-surgery and 6 Months Post-surgery
Change in Attention
Time Frame: 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).
Pre-surgery and 6 Months Post-surgery
Change in Problem Solving
Time Frame: Pre-surgery and 6 Months Post-surgery
As assessed by the Wisconsin Card Sorting Test (Min/Max: 50-150, Higher score means better outcome).
Pre-surgery and 6 Months Post-surgery
Change in Mental Flexibility
Time Frame: 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).
Pre-surgery and 6 Months Post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kayela Arrotta

Collaborators

The Cleveland Clinic
American Psychological Association (APA)
American Epilepsy Society

Investigators

  • Principal Investigator: Kayela Arrotta, PhD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2023

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Estimated)

October 31, 2025

Last Update Submitted That Met QC Criteria

October 29, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 23-212

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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