Recruiting

ReBOOT

Sponsor:

Kayela Arrotta

Code:

NCT05992402

Conditions

Epilepsy

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

ReBOOT program

Study Details

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.

Conditions

Epilepsy

Study ID

NCT05992402

Start date

Dec 6, 2023

Status verified date

Jun, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

no intervention: 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.

Interventions

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.

Primary outcome measure

  • Intervention attendance [ Time Frame: 5-6 Weeks post study enrollment ]
  • Rate of Homework Completion [ Time Frame: 5-6 Weeks post study enrollment ]
  • Study Attrition [ Time Frame: 5-6 Weeks post study enrollment ]
  • Intervention Efficacy based on Quality of Life [ Time Frame: 5-6 weeks post study enrollment, 6 month, 12 month ]

Central Contacts and Locations

Central contacts

Kayela Arrotta, PhD

216-444-6101ArrottK@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Kayela Arrotta, PhD

216-444-6101ArrottK@ccf.org

More Information

Sponsor

Kayela Arrotta

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kayela Arrotta on 2026-06-18.