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Search / Trial NCT05954182

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

Launched by KAYELA ARROTTA · Jul 12, 2023

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial, called "Cognitive Enhancement Intervention for Creating a Healthy L.I.F.E," is looking at whether special brain training can help people with epilepsy have better focus and overall brain health. If you have epilepsy and are between the ages of 18 and 60, you might be eligible to join. To participate, you should be able to understand and read English, have access to the internet for virtual meetings, and have been diagnosed with epilepsy. The study is not for those who have had epilepsy surgery or are currently participating in another epilepsy study.

Participants will take part in weekly online group sessions led by a brain health expert for 12 weeks. After that, you’ll continue practicing what you’ve learned for another 9 months on your own. During the study, you will fill out online questionnaires to help researchers see how effective the brain training is. The entire study lasts for one year, and you will be randomly assigned to either receive the brain training or to a group that does not receive it. This research aims to discover if this training can make a positive difference in brain health for those living with epilepsy.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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
  • Adults, aged 18-60 years old, with diagnosed epilepsy
  • Subjective cognitive difficulties based on patient self-report or objective cognitive deficits as determined by neuropsychological tests
  • 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 epilepsy surgery
  • Willing and able to participate in cognitive intervention
  • Exclusion Criteria:
  • Patients with a current diagnosis of non-epileptic or psychogenic seizures
  • Any patient that has engaged in any form of cognitive rehabilitation/intervention within the last 6 months
  • Patients currently enrolled in another interventional study for epilepsy at the time of enrollment
  • Anticipated or scheduled epilepsy surgery within 6 months
  • Pending litigation related to the cause of epilepsy unless litigation is related to disability application
  • 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
  • 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
  • Currently pregnant or less than 6 weeks postpartum
  • 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
  • Participants who require an LAR or lack capacity to consent for themselves

About Kayela Arrotta

Kayela Arrotta is a dedicated clinical trial sponsor focused on advancing medical research and improving patient outcomes through innovative trial designs and robust data management. With a commitment to ethical practices and regulatory compliance, Kayela Arrotta collaborates with healthcare professionals, research institutions, and pharmaceutical companies to facilitate the development of novel therapies. The organization emphasizes transparency, patient safety, and scientific rigor, striving to contribute valuable insights to the medical community and enhance the quality of care across diverse therapeutic areas.

Locations

Cleveland, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Kayela Arrotta, PhD

Principal Investigator

The Cleveland Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported