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Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery (ReBOOT)

Primary Purpose

Epilepsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ReBOOT program
Sponsored by
Kayela Arrotta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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 neurosurgery Willing and able to participate in cognitive intervention Exclusion Criteria: Patients with a history of non-epileptic or psychogenic seizures Any patient that has engaged in any form of cognitive rehabilitation/intervention within the last 6 months Pending litigation related to the cause of epilepsy or current application for long term disability 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Treatment-as-Usual

    Arm Description

    Participants in this arm will receive 2 one-on-one virtual education sessions as well as 4 virtual group education sessions prior to their epilepsy surgery.

    Participants in this arm will not receive the education sessions and will receive standard epilepsy care prior to their surgery.

    Outcomes

    Primary Outcome Measures

    Recruitment success
    As determined by number of patients contacted vs enrolled
    Intervention attendance
    As determined by weekly group attendance and the number of weeks it takes each patient to complete all four rotating sessions
    Rate of Homework Completion
    As determined by self-reported whether or not patient attempted to complete or completed their homework
    Study Attrition
    As determined by number of patients who do not complete the ReBOOT program and the reasons why
    Intervention Efficacy based on Functional Status - Based on The Instrumental Activities of Daily Living-Compensation questionnaire score
    The Instrumental Activities of Daily Living-Compensation questionnaire (Min/Max: 27-216, higher score means worse outcome)
    Intervention Efficacy based on Functional Status - Based on The Quality of Life in Epilepsy questionnaire score
    Quality of Life in Epilepsy questionnaire (Min/Max: 0-100, higher score means better outcome)

    Secondary Outcome Measures

    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)
    Change in Stress
    As assessed by the Perceived Stress Scale 4 (Min/Max: 0-16, higher score means worse outcome)
    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)
    Surgery Satisfaction assessed by Epilepsy Surgery Satisfaction Questionnaire
    Min/Max: 19-133, higher score means better outcome

    Full Information

    First Posted
    July 24, 2023
    Last Updated
    September 11, 2023
    Sponsor
    Kayela Arrotta
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05992402
    Brief Title
    Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery
    Acronym
    ReBOOT
    Official Title
    Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    June 2028 (Anticipated)
    Study Completion Date
    June 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Kayela Arrotta

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 recruitment, 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 compensatory strategy use, psychosocial factors, and surgical expectations and 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Participants in this arm will receive 2 one-on-one virtual education sessions as well as 4 virtual group education sessions prior to their epilepsy surgery.
    Arm Title
    Treatment-as-Usual
    Arm Type
    No Intervention
    Arm Description
    Participants in this arm will not receive the education sessions and will receive standard epilepsy care prior to their surgery.
    Intervention Type
    Behavioral
    Intervention Name(s)
    ReBOOT program
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Recruitment success
    Description
    As determined by number of patients contacted vs enrolled
    Time Frame
    5-6 Weeks post study enrollment
    Title
    Intervention attendance
    Description
    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
    Title
    Rate of Homework Completion
    Description
    As determined by self-reported whether or not patient attempted to complete or completed their homework
    Time Frame
    5-6 Weeks post study enrollment
    Title
    Study Attrition
    Description
    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
    Title
    Intervention Efficacy based on Functional Status - Based on The Instrumental Activities of Daily Living-Compensation questionnaire score
    Description
    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, 6 month, 12 month
    Title
    Intervention Efficacy based on Functional Status - Based on The Quality of Life in Epilepsy questionnaire score
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Change in Subjective Cognitive Function
    Description
    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
    Title
    Change in Stress
    Description
    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
    Title
    Change in Mood
    Description
    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 month
    Title
    Surgery Satisfaction assessed by Epilepsy Surgery Satisfaction Questionnaire
    Description
    Min/Max: 19-133, higher score means better outcome
    Time Frame
    6 month, 12 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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 neurosurgery Willing and able to participate in cognitive intervention Exclusion Criteria: Patients with a history of non-epileptic or psychogenic seizures Any patient that has engaged in any form of cognitive rehabilitation/intervention within the last 6 months Pending litigation related to the cause of epilepsy or current application for long term disability 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kayela Arrotta, PhD
    Phone
    216-444-6101
    Email
    ArrottK@ccf.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kayela Arrotta, PhD
    Organizational Affiliation
    The Cleveland Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Citation
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