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ReBOOT Program for Epilepsy (ReBOOT Trial)

N/A

Recruiting

Led By Kayela Arrotta, PhD

Research Sponsored by Kayela Arrotta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to independently provide informed consent

No history of neurosurgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5-6 weeks post study enrollment, 6 month, 12 month

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying if an educational program can help people who are having epilepsy surgery lower their risk of cognitive decline afterward. Participants get virtual sessions and complete surveys over the course of 5-6 weeks before surgery.

Who is the study for?

This trial is for adults aged 18-60 with diagnosed epilepsy who are candidates for surgery, can read at an 8th-grade level or higher, and can give informed consent. Participants need internet access for online sessions. Those with a history of neurosurgery or inability to participate in cognitive interventions cannot join.

What is being tested?

The ReBOOT program is being tested to see if it helps prevent cognitive decline after epilepsy surgery. It includes 2 individual and 4 group virtual sessions over 5-6 weeks before surgery, plus surveys up to a year post-surgery, compared against standard pre-surgical care.

What are the potential side effects?

Since the intervention involves educational programs rather than medication, traditional side effects are not expected. However, participants may experience fatigue or stress from additional time commitments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can understand and agree to the study on my own.

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I have never had brain surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5-6 weeks post study enrollment, 6 month, 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5-6 weeks post study enrollment, 6 month, 12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-6 weeks post study enrollment, 6 month, 12 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intervention Efficacy based on Quality of Life

Intervention attendance

Rate of Homework Completion

+1 more

Secondary study objectives

Change in Locus of Control

Change in Mood

Change in Self-Efficacy

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 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.

Group II: Treatment-as-UsualActive Control1 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.

0 / 2Eligibility criteria met