Clinical trial NCT05992402: Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery
Official title: Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: American Psychological Association (APA)
name: American Epilepsy Society
name: The Cleveland Clinic
First posted: 2023-08-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

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.

Primary outcomes:
measure: Intervention attendance
timeFrame: 5-6 Weeks post study enrollment
measure: Rate of Homework Completion
timeFrame: 5-6 Weeks post study enrollment
measure: Study Attrition
timeFrame: 5-6 Weeks post study enrollment
measure: Intervention Efficacy based on Quality of Life
timeFrame: 5-6 weeks post study enrollment, 6 month, 12 month
Secondary outcomes:
measure: Change in Subjective Cognitive Function
timeFrame: 5-6 weeks post study enrollment, 6 month, 12 month
measure: Change in Stress
timeFrame: 5-6 weeks post study enrollment, 6 month, 12 month
measure: Change in Mood
timeFrame: 5-6 weeks post study enrollment, 6 month, 12 month
measure: Surgery Satisfaction assessed by Epilepsy Surgery Satisfaction Questionnaire
timeFrame: 6 month, 12 month
measure: Intervention Efficacy based on Functional Status
timeFrame: 5-6 weeks post study enrollment, 6 month, 12 month
measure: Satisfaction with ReBOOT
timeFrame: 5-6 weeks post study enrollment
measure: Change in Self-Efficacy
timeFrame: 5-6 weeks post study enrollment, 6 month, 12 month
measure: Change in Locus of Control
timeFrame: 5-6 weeks post study enrollment, 6 month, 12 month
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Kayela Arrotta, PhD
role: PRINCIPAL_INVESTIGATOR
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