Cognitive intervention to improve brain health in epilepsy patients
Cognitive Enhancement Intervention for Creating a Healthy L.I.F.E (Lifestyle Interventions for Epilepsy)
This study is testing if a new brain training program can help adults with epilepsy think better and improve their overall brain health compared to those who just receive regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05954182 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of cognitive interventions in adults with diagnosed epilepsy to reduce cognitive lapses and enhance overall brain health. Participants will engage in weekly virtual group sessions led by a neuropsychologist for 12 weeks, followed by a 9-month self-study period. The study will compare outcomes between those receiving the cognitive intervention and a control group continuing standard care. Assessments will include cognitive tests and health questionnaires to measure the intervention's impact on daily functioning and quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with diagnosed epilepsy and objective cognitive deficits.
Not a fit: Patients with non-epileptic seizures or those who have recently undergone cognitive rehabilitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve cognitive function and quality of life for patients with epilepsy.
How similar studies have performed: While cognitive interventions for epilepsy are being explored, this specific approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Kayela Arrotta, PhD — The Cleveland Clinic
- Study coordinator: Anthony Lioi, PhD
- Email: lioia2@ccf.org
- Phone: 216-444-5666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.