Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery
ConditionEpilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorKayela Arrotta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
ReBOOT program
BehavioralThis is a virtual cognitive intervention led by a clinical neuropsychologist. Participants will attend 2 one-on-one individual sessions and 4 group sessions prior to their epilepsy surgery. Groups will be made up of 3-10 participants. The intervention is designed to provide participants with information about possible changes and/or challenges they may experience after epilepsy surgery, as well as cognitive strategies to implement prior to surgery to increase effectiveness of compensation for any new cognitive difficulties that may be experienced following surgery.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: Treatment-as-UsualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Intervention attendance
As determined by weekly group attendance and the number of weeks it takes each patient to complete all four rotating sessions
Time frame
5-6 Weeks post study enrollment2
Rate of Homework Completion
As determined by self-reported whether or not patient attempted to complete or completed their homework
Time frame
5-6 Weeks post study enrollment3
Study Attrition
As determined by number of patients who do not complete the ReBOOT program and the reasons why
Time frame
5-6 Weeks post study enrollment4
Intervention Efficacy based on Quality of Life
As assessed by the Quality of Life in Epilepsy questionnaire (Min/Max: 0-100, higher score means better outcome)
Time frame
5-6 weeks post study enrollment, 6 month, 12 monthSecondary outcomes
1
Change in Subjective Cognitive Function
As assessed by the Memory Assessment Clinics Scale for Epilepsy (Min/Max: 30-150, Higher score means better outcome) and the Everyday Compensation Scale (Min/Max: 0-220, higher score means better outcome)
Time frame
5-6 weeks post study enrollment, 6 month, 12 month2
Change in Stress
As assessed by the Perceived Stress Scale 4 (Min/Max: 0-16, higher score means worse outcome)
Time frame
5-6 weeks post study enrollment, 6 month, 12 month3
Change in Mood
As assessed by the Patient Health Questionnaire (Min/Max: 0-24, higher score means worse outcome) and the Generalized Anxiety Disorder (Min/Max: 0-21, higher score means worse outcome)
Time frame
5-6 weeks post study enrollment, 6 month, 12 month4
Surgery Satisfaction assessed by Epilepsy Surgery Satisfaction Questionnaire
Min/Max: 19-133, higher score means better outcome
Time frame
6 month, 12 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kayela Arrotta
Lead sponsor
The Cleveland Clinic
Sponsor institution
American Psychological Association (APA)
Collaborator
American Epilepsy Society
Collaborator
The Cleveland Clinic
Collaborator
Source ClinicalTrials.gov