Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery
NCT ID: NCT05992402
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
64 participants
INTERVENTIONAL
2023-12-06
2028-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Treatment-as-Usual
Treatment as usual but will also receive three brief 5-minute phone calls over 6-weeks after initial enrollment. These phone calls are not therapeutic in nature but provide control participants with brief engagement in study-related activities to ensure that any benefits seen between groups are not simply attributable to study participation.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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American Psychological Association (APA)
OTHER
American Epilepsy Society
OTHER
The Cleveland Clinic
OTHER
Kayela Arrotta
OTHER
Responsible Party
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Kayela Arrotta
Principal Investigator
Principal Investigators
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Kayela Arrotta, PhD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Liu SY, Yang XL, Chen B, Hou Z, An N, Yang MH, Yang H. Clinical outcomes and quality of life following surgical treatment for refractory epilepsy: a systematic review and meta-analysis. Medicine (Baltimore). 2015 Feb;94(6):e500. doi: 10.1097/MD.0000000000000500.
Sherman EM, Wiebe S, Fay-McClymont TB, Tellez-Zenteno J, Metcalfe A, Hernandez-Ronquillo L, Hader WJ, Jette N. Neuropsychological outcomes after epilepsy surgery: systematic review and pooled estimates. Epilepsia. 2011 May;52(5):857-69. doi: 10.1111/j.1528-1167.2011.03022.x. Epub 2011 Mar 22.
Busch RM, Floden DP, Ferguson L, Mahmoud S, Mullane A, Jones S, Jehi L, Bingaman W, Najm IM. Neuropsychological outcome following frontal lobectomy for pharmacoresistant epilepsy in adults. Neurology. 2017 Feb 14;88(7):692-700. doi: 10.1212/WNL.0000000000003611. Epub 2017 Jan 13.
Pauli C, Schwarzbold ML, Diaz AP, de Oliveira Thais MER, Kondageski C, Linhares MN, Guarnieri R, de Lemos Zingano B, Ben J, Nunes JC, Markowitsch HJ, Wolf P, Wiebe S, Lin K, Walz R. Predictors of meaningful improvement in quality of life after temporal lobe epilepsy surgery: A prospective study. Epilepsia. 2017 May;58(5):755-763. doi: 10.1111/epi.13721. Epub 2017 Mar 23.
Qiu Y, Zhang J, Yan Y, Liu W, Zhan S, Huang P, Deng Y. Predictors of meaningful improvement in quality of life after selective amygdalohippocampectomy in Chinese patients with refractory temporal lobe epilepsy: A prospective study. Epilepsy Behav. 2019 Aug;97:1-7. doi: 10.1016/j.yebeh.2019.05.006. Epub 2019 Jun 7.
Farina E, Raglio A, Giovagnoli AR. Cognitive rehabilitation in epilepsy: An evidence-based review. Epilepsy Res. 2015 Jan;109:210-8. doi: 10.1016/j.eplepsyres.2014.10.017. Epub 2014 Nov 6.
Streltzov NA, Schmidt SS, Schommer LM, Zhao W, Tosteson TD, Mazanec MT, Kiriakopoulos ET, Chu F, Henninger HL, Nagle K, Roth RM, Jobst B. Effectiveness of a Self-Management Program to Improve Cognition and Quality of Life in Epilepsy: A Pragmatic, Randomized, Multicenter Trial. Neurology. 2022 May 24;98(21):e2174-e2184. doi: 10.1212/WNL.0000000000200346. Epub 2022 Apr 6.
Baxendale S. Cognitive rehabilitation and prehabilitation in people with epilepsy. Epilepsy Behav. 2020 May;106:107027. doi: 10.1016/j.yebeh.2020.107027. Epub 2020 Mar 21.
Rodakowski J, Saghafi E, Butters MA, Skidmore ER. Non-pharmacological interventions for adults with mild cognitive impairment and early stage dementia: An updated scoping review. Mol Aspects Med. 2015 Jun-Oct;43-44:38-53. doi: 10.1016/j.mam.2015.06.003. Epub 2015 Jun 10.
Daksla N, Nguyen V, Jin Z, Bergese SD. Brain Prehabilitation for Oncologic Surgery. Curr Oncol Rep. 2022 Nov;24(11):1513-1520. doi: 10.1007/s11912-022-01312-1. Epub 2022 Jul 28.
Humeidan ML, Reyes JC, Mavarez-Martinez A, Roeth C, Nguyen CM, Sheridan E, Zuleta-Alarcon A, Otey A, Abdel-Rasoul M, Bergese SD. Effect of Cognitive Prehabilitation on the Incidence of Postoperative Delirium Among Older Adults Undergoing Major Noncardiac Surgery: The Neurobics Randomized Clinical Trial. JAMA Surg. 2021 Feb 1;156(2):148-156. doi: 10.1001/jamasurg.2020.4371.
McCann M, Stamp N, Ngui A, Litton E. Cardiac Prehabilitation. J Cardiothorac Vasc Anesth. 2019 Aug;33(8):2255-2265. doi: 10.1053/j.jvca.2019.01.023. Epub 2019 Jan 12.
Smith NA, Martin G, Marginson B. Preoperative assessment and prehabilitation in patients with obesity undergoing non-bariatric surgery: A systematic review. J Clin Anesth. 2022 Jun;78:110676. doi: 10.1016/j.jclinane.2022.110676. Epub 2022 Feb 10.
Garcia-Delgado Y, Lopez-Madrazo-Hernandez MJ, Alvarado-Martel D, Miranda-Calderin G, Ugarte-Lopetegui A, Gonzalez-Medina RA, Hernandez-Lazaro A, Zamora G, Perez-Martin N, Sanchez-Hernandez RM, Ibarra-Gonzalez A, Bengoa-Dolon M, Mendoza-Vega CT, Appelvik-Gonzalez SM, Caballero-Diaz Y, Hernandez-Hernandez JR, Wagner AM. Prehabilitation for Bariatric Surgery: A Randomized, Controlled Trial Protocol and Pilot Study. Nutrients. 2021 Aug 24;13(9):2903. doi: 10.3390/nu13092903.
Other Identifiers
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IRB 23-212
Identifier Type: -
Identifier Source: org_study_id
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