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

Kayela Arrotta

Status

Enrolling

Conditions

Epilepsy

Treatments

Behavioral: Cognitive Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05954182

IRB 22-1005

Details and patient eligibility

About

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.

Full 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.

Enrollment

170 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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
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

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