Cognitive Enhancement Intervention for Creating a Healthy L.I.F.E (Lifestyle Interventions for Epilepsy)
NCT ID: NCT05954182
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
170 participants
INTERVENTIONAL
2023-09-20
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Managing Epilepsy Well- WebEase Project
NCT00726076
Goals for Epilepsy Clinic Visits Trial
NCT05928598
NYU Epilepsy Self-Management Study
NCT07087821
Enhancing Medical Compliance and Health-related Quality of Life of Patients With Epilepsy
NCT02547389
Web-based Intervention to Improve Executive Functioning in Teens With Epilepsy (Epilepsy Journey)
NCT02925663
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cognitive Intervention
Participants in this group will receive weekly, live, virtual group sessions for 12 weeks
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.
Control
Participants in this group will NOT receive the group sessions
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kayela Arrotta
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kayela Arrotta
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kayela Arrotta, PhD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cleveland Clinic
Cleveland, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Motamedi G, Meador K. Epilepsy and cognition. Epilepsy Behav. 2003 Oct;4 Suppl 2:S25-38. doi: 10.1016/j.yebeh.2003.07.004.
Baxendale S. Cognitive rehabilitation and prehabilitation in people with epilepsy. Epilepsy Behav. 2020 May;106:107027. doi: 10.1016/j.yebeh.2020.107027. Epub 2020 Mar 21.
Farina E, Raglio A, Giovagnoli AR. Cognitive rehabilitation in epilepsy: An evidence-based review. Epilepsy Res. 2015 Jan;109:210-8. doi: 10.1016/j.eplepsyres.2014.10.017. Epub 2014 Nov 6.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB 22-1005
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.