Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery
Recruiting · NCT05992402 · Interventional (participants receive a specific treatment) · Lead sponsor: Kayela Arrotta
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed across 1 US state.
- Cleveland Clinic - Cleveland, Ohio, United States