EpilepsyReBOOTNCT05992402
Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery
A study testing ReBOOT program in people with Epilepsy, run by Kayela Arrotta at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- ReBOOT program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2023to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Kayela Arrotta, PhD, 216-444-6101, ArrottK@ccf.org
About this study
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.
Read the 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 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.
- Conditions
- Epilepsy
- Being tested
- ReBOOT program
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReBOOT programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: ReBOOT program |
| Treatment-as-Usual | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention attendance
As determined by weekly group attendance and the number of weeks it takes each patient to complete all four rotating sessions
Measured: 5-6 Weeks post study enrollment
Rate of Homework Completion
As determined by self-reported whether or not patient attempted to complete or completed their homework
Measured: 5-6 Weeks post study enrollment
Study Attrition
As determined by number of patients who do not complete the ReBOOT program and the reasons why
Measured: 5-6 Weeks post study enrollment
Intervention Efficacy based on Quality of Life
As assessed by the Quality of Life in Epilepsy questionnaire (Min/Max: 0-100, higher score means better outcome)
Measured: 5-6 weeks post study enrollment, 6 month, 12 month
Secondary outcomes (15)
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)
Measured: 5-6 weeks post study enrollment, 6 month, 12 month
Change in Stress
As assessed by the Perceived Stress Scale 4 (Min/Max: 0-16, higher score means worse outcome)
Measured: 5-6 weeks post study enrollment, 6 month, 12 month
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)
Measured: 5-6 weeks post study enrollment, 6 month, 12 month
Surgery Satisfaction assessed by Epilepsy Surgery Satisfaction Questionnaire
Min/Max: 19-133, higher score means better outcome
Measured: 6 month, 12 month
Intervention Efficacy based on Functional Status
As assessed by the Instrumental Activities of Daily Living-Compensation questionnaire (Min/Max: 27-216, higher score means worse outcome)
Measured: 5-6 weeks post study enrollment, 6 month, 12 month
Satisfaction with ReBOOT
As assessed by the qualitative Satisfaction of ReBOOT questionnaire and qualitative feedback
Measured: 5-6 weeks post study enrollment
Change in Self-Efficacy
As assessed by the General Self-Efficacy Scale questionnaire (Min/Max: 10-40, higher score means greater self-efficacy)
Measured: 5-6 weeks post study enrollment, 6 month, 12 month
Change in Locus of Control
As assessed by the Multidimensional Health Locus of Control questionnaire (Min/Max: 24-144, higher score means greater locus of control)
Measured: 5-6 weeks post study enrollment, 6 month, 12 month
Change in Word List Recall
As assessed by the Rey Auditory Verbal Learning Task (Min/Max: 50-150, Higher score means better outcome).
Measured: Pre-surgery and 6 Months Post-surgery
Change in Story Recall
As assessed by the Wechsler Memory Scale - 4th Edition Logical Memory (Min/Max: 1-19, Higher score means better outcome).
Measured: Pre-surgery and 6 Months Post-surgery
Change in Visual Memory Recall
As assessed by the Wechsler Memory Scale - 4th Edition Visual Reproductions (Min/Max: 1-19, Higher score means better outcome).
Measured: Pre-surgery and 6 Months Post-surgery
Change in Naming
As assessed by the Boston Naming Test (Min/Max: 0-60, Higher score means better outcome).
Measured: Pre-surgery and 6 Months Post-surgery
Change in Attention
As assessed by the Wechsler Adult Intelligence Scale - 4th Edition Digit Span (Min/Max: 1-19, Higher score means better outcome).
Measured: Pre-surgery and 6 Months Post-surgery
Change in Problem Solving
As assessed by the Wisconsin Card Sorting Test (Min/Max: 50-150, Higher score means better outcome).
Measured: Pre-surgery and 6 Months Post-surgery
Change in Mental Flexibility
As assessed by the Trail Making Test Part B (Min/Max: 20-80, Higher score means better outcome).
Measured: Pre-surgery and 6 Months Post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start6 Dec 2023
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kayela Arrotta
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychological Association (APA), American Epilepsy Society, The Cleveland Clinic
- Responsible party
- Sponsor-investigator, Kayela Arrotta, The Cleveland Clinic
- Investigators
- Kayela Arrotta, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992402
- Sponsor's protocol ID
- IRB 23-212
- Acronym
- ReBOOT
- Status last verified
- Jun 2026
- First submitted
- 24 Jul 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25674741Sherman 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.
PubMed 21426331Busch 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.
PubMed 28087827Pauli 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.
PubMed 28332703Qiu 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.
PubMed 31181423Farina 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.
PubMed 25524861Streltzov 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.
PubMed 35387855Baxendale 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.
PubMed 32208338Rodakowski 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.
PubMed 26070444Daksla 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.
PubMed 35900715Humeidan 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.
PubMed 33175114McCann 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.
PubMed 30765210Smith 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.
PubMed 35152081Garcia-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.
PubMed 34578781Arrotta K, Babiker S, Lake J, Thompson N, Lioi A, Najm I, Busch RM. Readiness Brain Operation Optimization Training (ReBOOT) protocol: a feasibility randomised controlled trial for a cognitive prehabilitation programme for epilepsy surgery conducted at Cleveland Clinic, USA. BMJ Open. 2025 Nov 12;15(11):e091893. doi: 10.1136/bmjopen-2024-091893.
PubMed 41224310
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery
- ClinicalTrials.gov ID
- NCT05992402
- Acronym / sponsor ID
- ReBOOT / IRB 23-212
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Kayela ArrottaUniversity, hospital or other
- Collaborators
- American Psychological Association (APA), American Epilepsy Society, The Cleveland Clinic
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: ReBOOT programParticipants 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. |
| Treatment-as-Usual | No intervention | –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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReBOOT programThis 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. | Behavioural | Intervention |
Primary outcome
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
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
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
Intervention Efficacy based on Quality of Life
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)
15 secondary outcomes
Change in Subjective Cognitive Function
Time frame: 5-6 weeks post study enrollment, 6 month, 12 month
Change in Stress
Time frame: 5-6 weeks post study enrollment, 6 month, 12 month
Change in Mood
Time frame: 5-6 weeks post study enrollment, 6 month, 12 month
Surgery Satisfaction assessed by Epilepsy Surgery Satisfaction Questionnaire
Time frame: 6 month, 12 month
Intervention Efficacy based on Functional Status
Time frame: 5-6 weeks post study enrollment, 6 month, 12 month
Satisfaction with ReBOOT
Time frame: 5-6 weeks post study enrollment
Change in Self-Efficacy
Time frame: 5-6 weeks post study enrollment, 6 month, 12 month
Change in Locus of Control
Time frame: 5-6 weeks post study enrollment, 6 month, 12 month
Change in Word List Recall
Time frame: Pre-surgery and 6 Months Post-surgery
Change in Story Recall
Time frame: Pre-surgery and 6 Months Post-surgery
Change in Visual Memory Recall
Time frame: Pre-surgery and 6 Months Post-surgery
Change in Naming
Time frame: Pre-surgery and 6 Months Post-surgery
Change in Attention
Time frame: Pre-surgery and 6 Months Post-surgery
Change in Problem Solving
Time frame: Pre-surgery and 6 Months Post-surgery
Change in Mental Flexibility
Time frame: Pre-surgery and 6 Months Post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Background: PubMed 25674741Liu 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.
- Background: PubMed 21426331Sherman 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.
- Background: PubMed 28087827Busch 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.
- Background: PubMed 28332703Pauli 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.
- Background: PubMed 31181423Qiu 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.
- Background: PubMed 25524861Farina 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.
- Background: PubMed 35387855Streltzov 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.
- Background: PubMed 32208338Baxendale 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.
- Background: PubMed 26070444Rodakowski 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.
- Background: PubMed 35900715Daksla 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.
- Background: PubMed 33175114Humeidan 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.
- Background: PubMed 30765210McCann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kayela Arrotta, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReBOOT program in people with Epilepsy, run by Kayela Arrotta at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kayela Arrotta, PhD (216-444-6101, ArrottK@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention attendance (time frame: 5-6 Weeks post study enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05992402, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026; AzTrials last refreshed its copy on 2 Nov 2026.