Training program to prepare patients for epilepsy surgery
Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery
This study is testing a new training program for people with epilepsy to see if it helps them feel better and have a smoother experience before and after surgery compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05992402 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a new educational program designed to prepare patients for epilepsy surgery, potentially reducing the risk of cognitive decline post-surgery. Participants will engage in two individual virtual sessions and four group sessions over 5-6 weeks, alongside completing online surveys and questionnaires. The study will compare outcomes between those who undergo the educational program and those receiving standard care, focusing on quality of life and surgical satisfaction. Researchers will also assess the feasibility of the program through attendance tracking and patient feedback.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with diagnosed epilepsy who are confirmed surgical candidates and can provide informed consent.
Not a fit: Patients who have undergone cognitive rehabilitation in the last 6 months or are involved in ongoing litigation related to their epilepsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could help patients maintain cognitive function and improve their overall experience and satisfaction with epilepsy surgery.
How similar studies have performed: While similar cognitive interventions have shown promise in other contexts, this specific approach for epilepsy surgery is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Kayela Arrotta, PhD — The Cleveland Clinic
- Study coordinator: Kayela Arrotta, PhD
- Email: ArrottK@ccf.org
- Phone: 216-444-6101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.