Clinical trial NCT05954182: Cognitive Enhancement Intervention for Creating a Healthy L.I.F.E (Lifestyle Interventions for Epilepsy)
Official title: Cognitive Enhancement Intervention for Creating a Healthy L.I.F.E (Lifestyle Interventions for Epilepsy)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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
* Objective cognitive deficits as determined by a cognitive screening measure (Brief Assessment of Cognitive Health \[BACH\])
* 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 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

Primary outcomes:
measure: Change in Everyday Functioning
timeFrame: 3-12 months from the beginning of the intervention
Secondary outcomes:
measure: Change in Cognitive function
timeFrame: 3-12 months
measure: Change in Quality of Life
timeFrame: 3-12 months
measure: Change in Stress
timeFrame: 3-12 months
measure: Change in Mood
timeFrame: 3-12 months
measure: Change in Mood
timeFrame: 3-12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Kayela Arrotta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Motamedi G, Meador K. Epilepsy and cognition. Epilepsy Behav. 2003 Oct;4 Suppl 2:S25-38. doi: 10.1016/j.yebeh.2003.07.004.
citation: 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.
citation: 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.