Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Kayela Arrotta
Study ID
NCT05992402
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • ReBOOT program — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Dec 6, 2023
Status verified
Oct 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Intervention attendance [ Time Frame: 5-6 Weeks post study enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Kayela Arrotta, PhD
[email protected]
216-444-6101

Find similar trials in Cleveland, OH

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
Cleveland Clinic· Cleveland, OH

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