Cleveland Clinic
Cleveland, Ohio, 44195, United States
Location status: Recruiting
NCT Number: NCT05992402
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44195, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This 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.
Time frame: 5-6 Weeks post study enrollment
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 enrollment
As determined by self-reported whether or not patient attempted to complete or completed their homework
Time frame: 5-6 Weeks post study enrollment
As determined by number of patients who do not complete the ReBOOT program and the reasons why
Time frame: 5-6 weeks post study enrollment, 6 month, 12 month
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 month
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 month
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 month
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: 6 month, 12 month
Min/Max: 19-133, higher score means better outcome
Time frame: 5-6 weeks post study enrollment, 6 month, 12 month
As assessed by the Instrumental Activities of Daily Living-Compensation questionnaire (Min/Max: 27-216, higher score means worse outcome)
Time frame: 5-6 weeks post study enrollment
As assessed by the qualitative Satisfaction of ReBOOT questionnaire and qualitative feedback
Time frame: 5-6 weeks post study enrollment, 6 month, 12 month
As assessed by the General Self-Efficacy Scale questionnaire (Min/Max: 10-40, higher score means greater self-efficacy)
Time frame: 5-6 weeks post study enrollment, 6 month, 12 month
As assessed by the Multidimensional Health Locus of Control questionnaire (Min/Max: 24-144, higher score means greater locus of control)
Time frame: Pre-surgery and 6 Months Post-surgery
As assessed by the Rey Auditory Verbal Learning Task (Min/Max: 50-150, Higher score means better outcome).
Time frame: Pre-surgery and 6 Months Post-surgery
As assessed by the Wechsler Memory Scale - 4th Edition Logical Memory (Min/Max: 1-19, Higher score means better outcome).
Time frame: Pre-surgery and 6 Months Post-surgery
As assessed by the Wechsler Memory Scale - 4th Edition Visual Reproductions (Min/Max: 1-19, Higher score means better outcome).
Time frame: Pre-surgery and 6 Months Post-surgery
As assessed by the Boston Naming Test (Min/Max: 0-60, Higher score means better outcome).
Time frame: Pre-surgery and 6 Months Post-surgery
As assessed by the Wechsler Adult Intelligence Scale - 4th Edition Digit Span (Min/Max: 1-19, Higher score means better outcome).
Time frame: Pre-surgery and 6 Months Post-surgery
As assessed by the Wisconsin Card Sorting Test (Min/Max: 50-150, Higher score means better outcome).
Time frame: Pre-surgery and 6 Months Post-surgery
As assessed by the Trail Making Test Part B (Min/Max: 20-80, Higher score means better outcome).
Contact information is provided by the study sponsor or research team.
Kayela Arrotta
Other
Acronym: ReBOOT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02107989
Brain Diseases, Central Nervous System Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT02531880
Brain Diseases, Central Nervous System Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT01273129
Brain Diseases, Central Nervous System Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT04715646
Brain Diseases, Central Nervous System Diseases
Hawthorne, New York, United States
View Trial Details