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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05992402
Recruitment Status : Recruiting
First Posted : August 15, 2023
Last Update Posted : December 12, 2023
Sponsor:
Information provided by (Responsible Party):
Kayela Arrotta, The Cleveland Clinic

Study Description
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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.


Condition or disease Intervention/treatment Phase
Epilepsy Behavioral: ReBOOT program Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery
Actual Study Start Date : December 6, 2023
Estimated Primary Completion Date : June 2028
Estimated Study Completion Date : June 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
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.
 Behavioral: ReBOOT program
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.
No Intervention: Treatment-as-Usual
Participants in this arm will not receive the education sessions and will receive standard epilepsy care prior to their surgery.


Outcome Measures
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Primary Outcome Measures :
  1. Recruitment success [ Time Frame: 5-6 Weeks post study enrollment ]
    As determined by number of patients contacted vs enrolled

  2. Intervention attendance [ 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

  3. Rate of Homework Completion [ Time Frame: 5-6 Weeks post study enrollment ]
    As determined by self-reported whether or not patient attempted to complete or completed their homework

  4. Study Attrition [ 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

  5. Intervention Efficacy based on Functional Status - Based on The Instrumental Activities of Daily Living-Compensation questionnaire score [ Time Frame: 5-6 weeks post study enrollment, 6 month, 12 month ]
    The Instrumental Activities of Daily Living-Compensation questionnaire (Min/Max: 27-216, higher score means worse outcome)

  6. Intervention Efficacy based on Functional Status - Based on The Quality of Life in Epilepsy questionnaire score [ Time Frame: 5-6 weeks post study enrollment, 6 month, 12 month ]
    Quality of Life in Epilepsy questionnaire (Min/Max: 0-100, higher score means better outcome)


Secondary Outcome Measures :
  1. Change in Subjective Cognitive Function [ 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)

  2. Change in Stress [ 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)

  3. Change in Mood [ 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)

  4. Surgery Satisfaction assessed by Epilepsy Surgery Satisfaction Questionnaire [ Time Frame: 6 month, 12 month ]
    Min/Max: 19-133, higher score means better outcome


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05992402


Contacts
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Contact: Kayela Arrotta, PhD 216-444-6101 ArrottK@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Kayela Arrotta, PhD    216-444-6101    ArrottK@ccf.org   
Sponsors and Collaborators
Kayela Arrotta
Investigators
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Principal Investigator: Kayela Arrotta, PhD The Cleveland Clinic
More Information
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Publications:

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Responsible Party: Kayela Arrotta, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT05992402    
Other Study ID Numbers: IRB 23-212
First Posted: August 15, 2023    Key Record Dates
Last Update Posted: December 12, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases