NCT05954182

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Kayela Arrotta · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In this prospective, controlled, randomized study, investigators aim to assess the effectiveness of a cognitive intervention in improving daily function (primary outcome) in those with epilepsy. Investigators will also seek to understand how the cognitive intervention may impact objective and subjective cognitive function, quality of life, self-efficacy, locus of control, and mood (secondary outcomes). The study team will accomplish these objectives by comparing participants that are randomly assigned to the cognitive intervention arm (12 weekly virtual group sessions led by a neuropsychologist followed by 9 months of "self-study" in addition to their standard care) to participants randomly assigned to the control arm (continuation of their standard care during the 12 months of the study). Investigators will measure the effects of the intervention using cognitive assessments, and health and quality of life questionnaires. Investigators will also collect human biospecimens of enrolled participants to assess the biologic impact of the intervention.

Conditions

• Epilepsy

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Intervention	This is a virtual, group cognitive intervention. 12 live, weekly sessions will occur during the first 3 months of the study. Groups will be made up of 5-10 participants and will be led by a neuropsychologist. These sessions will include education on the brain and cognitive function as it relates to epilepsy, as well as compensatory strategies for use in daily life. After the 12 sessions, participants will be asked to continue to practice what they learned for the next nine months until their participation ends.

Timeline

• Start date: 2023-09-20
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-07-20
• Last updated: 2025-07-03

Locations

1 site across 1 country: United States