Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery

Epilepsy Clinical Trial

— ReBOOT  

Official title:

Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05992402
• Other study ID #: IRB 23-212
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2023
• Est. completion date: June 2028

Study information

• Verified date: June 2024
• Source: The Cleveland Clinic
• Contact: Kayela Arrotta, PhD
• Phone: 216-444-6101
• Email: ArrottK[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 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:

• 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.

• Significant hearing and/or vision loss that would preclude them from participating in remote cognitive testing and engaging in the cognitive intervention.

Related Conditions & MeSH terms

• Epilepsy

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Kayela Arrotta

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment success	As determined by number of patients contacted vs enrolled	5-6 Weeks post study enrollment
Primary	Intervention attendance	As determined by weekly group attendance and the number of weeks it takes each patient to complete all four rotating sessions	5-6 Weeks post study enrollment
Primary	Rate of Homework Completion	As determined by self-reported whether or not patient attempted to complete or completed their homework	5-6 Weeks post study enrollment
Primary	Study Attrition	As determined by number of patients who do not complete the ReBOOT program and the reasons why	5-6 Weeks post study enrollment
Primary	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)	5-6 weeks post study enrollment, 6 month, 12 month
Primary	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)	5-6 weeks post study enrollment, 6 month, 12 month
Secondary	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)	5-6 weeks post study enrollment, 6 month, 12 month
Secondary	Change in Stress	As assessed by the Perceived Stress Scale 4 (Min/Max: 0-16, higher score means worse outcome)	5-6 weeks post study enrollment, 6 month, 12 month
Secondary	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)	5-6 weeks post study enrollment, 6 month, 12 month
Secondary	Surgery Satisfaction assessed by Epilepsy Surgery Satisfaction Questionnaire	Min/Max: 19-133, higher score means better outcome	6 month, 12 month