Status:
RECRUITING
Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery
Lead Sponsor:
Kayela Arrotta
Collaborating Sponsors:
American Psychological Association (APA)
American Epilepsy Society
Conditions:
Epilepsy
Eligibility:
All Genders
18-60 years
Phase:
NA
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 expe...
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 preha...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05992402
Start Date
December 6 2023
End Date
June 1 2028
Last Update
October 31 2025
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195