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

NCT05954182 | Recruiting

• 1 other identifier: IRB 22-1005
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Change in Everyday Functioning

  As assessed by the Instrumental Activities of Daily Living-Compensation (IADL-C) questionnaire - Min/Max: 27-216 (higher score means worse outcome)

  3-12 months from the beginning of the intervention

Secondary Outcomes (5)

• Change in Cognitive function

  3-12 months

• Change in Quality of Life

  3-12 months

• Change in Stress

  3-12 months

• Change in Mood

  3-12 months

• Change in Mood

  3-12 months

Study Arms (2)

Cognitive Intervention

EXPERIMENTAL

Participants in this group will receive weekly, live, virtual group sessions for 12 weeks

Behavioral: Cognitive Intervention

Control

NO INTERVENTION

Participants in this group will NOT receive the group sessions

Interventions

Cognitive Intervention BEHAVIORAL

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.

Cognitive Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Kayela Arrotta: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Related Publications (3)

• Motamedi G, Meador K. Epilepsy and cognition. Epilepsy Behav. 2003 Oct;4 Suppl 2:S25-38. doi: 10.1016/j.yebeh.2003.07.004.

  PMID: 14527481 BACKGROUND

• 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.

  PMID: 32208338 BACKGROUND

• 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.

  PMID: 25524861 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Kayela Arrotta, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Lioi, PhD

CONTACT

216-444-5666; lioia2@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 20, 2023
• Study Start: September 20, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)