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

Running, not enrolling · Not applicable

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT05954182

Run by

Kayela Arrotta

People needed

170

Starts

2023-09-20

Expected to finish

2027-06-01

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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