Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery
Launched by KAYELA ARROTTA · Aug 7, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The ReBOOT trial is studying a new educational program designed to help patients prepare for epilepsy surgery. The main goal is to see if this program can reduce the chances of experiencing cognitive decline, which refers to difficulties with thinking and memory, after the surgery. Participants will take part in two individual virtual sessions and four group sessions over 5 to 6 weeks before their surgery. They will also complete online surveys at different points during the study, including up to a year after their surgery. This trial will compare the experiences of those who go through the educational program with those who receive standard care.
To join the study, participants need to be adults aged 18 to 60 who have been diagnosed with epilepsy and approved for surgery by their doctor. They should be fluent in English, able to read at an 8th-grade level or higher, and have access to the internet for online sessions. Participants should not have had any recent cognitive rehabilitation or other serious medical conditions that could affect their participation. This trial is currently looking for volunteers, and it could be a valuable opportunity for those preparing for epilepsy surgery to receive support that may help them during their recovery.
Gender
ALL
Eligibility 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.
About Kayela Arrotta
Kayela Arrotta is a dedicated clinical trial sponsor focused on advancing medical research and improving patient outcomes through innovative trial designs and robust data management. With a commitment to ethical practices and regulatory compliance, Kayela Arrotta collaborates with healthcare professionals, research institutions, and pharmaceutical companies to facilitate the development of novel therapies. The organization emphasizes transparency, patient safety, and scientific rigor, striving to contribute valuable insights to the medical community and enhance the quality of care across diverse therapeutic areas.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cleveland, Ohio, United States
Patients applied
Trial Officials
Kayela Arrotta, PhD
Principal Investigator
The Cleveland Clinic
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported