Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery

Last updated: October 29, 2025
Sponsor: Kayela Arrotta
Overall Status: Active - Recruiting

Phase

N/A

Condition

Epilepsy

Treatment

ReBOOT program

Clinical Study ID

NCT05992402
IRB 23-212
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults, aged 18-60 years old, with diagnosed epilepsy who have been confirmed as anappropriate 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 RangeAchievement 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 includeneuromodulation therapies for epilepsy (e.g., RNS, VNS, DBS)

  • Willing and able to participate in cognitive intervention

Exclusion

Exclusion Criteria:

  • Any patient that has engaged in any form of cognitive rehabilitation/interventionwithin the last 6 months

  • Ongoing litigation related to the cause of epilepsy, unless litigation is related toshort 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 asschizophrenia, active psychosis, active mania, and current suicidal ideation.

  • Significant hearing and/or vision loss that would preclude them from participatingin remote cognitive testing and engaging in the cognitive intervention.

Study Design

Total Participants: 64
Treatment Group(s): 1
Primary Treatment: ReBOOT program
Phase:
Study Start date:
December 06, 2023
Estimated Completion Date:
June 30, 2028

Study 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.

Connect with a study center

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

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