RECRUITING

Cognitive Enhancement Intervention for Creating a Healthy L.I.F.E (Lifestyle Interventions for Epilepsy)

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Conditions

Epilepsy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to test if cognitive interventions in those with diagnosed epilepsy can help lessen cognitive lapses and improve overall brain health. Participants will participate in weekly, virtual group sessions led by a neuropsychologist for 12 weeks. After the 12-week mark, participants will be asked to practice what they learned for 9 more months. Participants will be asked to complete online questionnaires at certain times during the study. Researchers will compare this intervention group to another group that did not get the intervention to see if the intervention improves brain health. Participation in each of these groups will be randomly assigned. Participation in the study will last for one year.

Official Title

Cognitive Enhancement Intervention for Creating a Healthy L.I.F.E (Lifestyle Interventions for Epilepsy)

Quick Facts

Study Start:2023-09-20
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05954182

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Potential patients will be identified if they have been, or are scheduled to be seen, either in-person or virtually for a clinical visit within the Cleveland Clinic Epilepsy Center
  2. * Adults, aged 18-60 years old, with diagnosed epilepsy
  3. * Objective cognitive deficits as determined by a cognitive screening measure (Brief Assessment of Cognitive Health \[BACH\])
  4. * Able to independently provide informed consent
  5. * Fluent in English
  6. * Reading abilities at or above 8th grade level as determined by the Wide Range Achievement Test- 4th Edition (WRAT-4), Reading subtest
  7. * Internet access and the ability to participate in online video streaming
  8. * No history of epilepsy surgery
  9. * Willing and able to participate in cognitive intervention
  1. * Patients with a current diagnosis of non-epileptic or psychogenic seizures
  2. * Any patient that has engaged in any form of cognitive rehabilitation/intervention within the last 6 months
  3. * Patients currently enrolled in another interventional study for epilepsy at the time of enrollment
  4. * Anticipated or scheduled epilepsy surgery within 6 months
  5. * Pending litigation related to the cause of epilepsy unless litigation is related to disability application
  6. * Undergoing intensive medical treatment for serious or life-threatening illness (e.g., chemotherapy, etc.) that, in the opinion of the investigator, would impact study participation
  7. * Serious psychiatric condition that, in the opinion of the investigator, would interfere with participation, such as schizophrenia, active psychosis, active mania, and current suicidal ideation
  8. * Currently pregnant or less than 6 weeks postpartum
  9. * Significant hearing and/or vision loss that, in the opinion of the investigator would preclude them from participating in remote cognitive testing and engaging in the cognitive intervention
  10. * Participants who require an LAR or lack capacity to consent for themselves

Contacts and Locations

Study Contact

Anthony Lioi, PhD
CONTACT
216-444-5666
lioia2@ccf.org

Principal Investigator

Kayela Arrotta, PhD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Kayela Arrotta

  • Kayela Arrotta, PhD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-20
Study Completion Date2026-06

Study Record Updates

Study Start Date2023-09-20
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Epilepsy