← Back to Search

Intervention 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

ReBOOT Trial 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.Check my eligibility

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.See study design

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.

ReBOOT Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

I have never had brain surgery.

ReBOOT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Intervention Efficacy based on Functional Status - Based on The Instrumental Activities of Daily Living-Compensation questionnaire score

Intervention Efficacy based on Functional Status - Based on The Quality of Life in Epilepsy questionnaire score

Intervention attendance

+3 more

Secondary outcome measures

Change in Mood

Change in Stress

Change in Subjective Cognitive Function

+1 more

ReBOOT 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

Participants in this arm will not receive the education sessions and will receive standard epilepsy care prior to their surgery.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kayela ArrottaLead Sponsor

1 Previous Clinical Trials

170 Total Patients Enrolled

1 Trials studying Epilepsy

170 Patients Enrolled for Epilepsy

Kayela Arrotta, PhDPrincipal InvestigatorThe Cleveland Clinic

1 Previous Clinical Trials

170 Total Patients Enrolled

1 Trials studying Epilepsy

170 Patients Enrolled for Epilepsy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the numerical scope of this research endeavor?

"Affirmative. Clinicaltrials.gov specifies that the research, posted on December 6th 2023 and recently updated on 8th of the same month, is actively searching for 150 participants at a single medical centre."

Answered by AI

Is there an opportunity to volunteer in this clinical trial?

"This clinical trial is seeking to recruit 150 patients who have epilepsy and are between 18 and 60 years of age."

Answered by AI

Is the participation in this research limited to adults only?

"Individuals between 18 and 60 years old are able to take part in this trial."

Answered by AI

Is this experiment welcoming participants now?

"Affirmative, clinicaltrials.gov illustrates that this trial is actively engaging patients at the moment. The study was initially published on December 6th 2023 and subsequently updated on December 8th 2023; it's currently looking for 150 volunteers to take part in the experiment from only one site."

Answered by AI

What are the aims of this exploration?

"This clinical trial will measure its primary outcome, recruitment success, over a 5-6 week period post enrolment and again after 6 months and 12 months. Secondary outcomes that will be assessed include Change in Stress (as measured by the Perceived Stress Scale 4), Change in Mood (defined through Patient Health Questionnaire scores) , Generalized Anxiety Disorder severity levels, as well as Surgery Satisfaction (evaluated via Epilepsy Surgery Satisfaction Questionnaire)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery

Kayela Arrotta 2023. "Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05992402.

All > Epilepsy