Epilepsy
Conditions
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.
Interventions
BEHAVIORALCognitive 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.
Sponsors
Kayela Arrotta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Everyday Functioning | 3-12 months from the beginning of the intervention | As assessed by the Instrumental Activities of Daily Living-Compensation (IADL-C) questionnaire - Min/Max: 27-216 (higher score means worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive function | 3-12 months | As assessed by neurocognitive testing and the Memory Assessment Clinics Scale for Epilepsy (MAC-E) questionnaire - Min/Max: 30-150 (higher score means better outcome) |
| Change in Quality of Life | 3-12 months | As assessed by The Quality of Life in Epilepsy (QOLIE) questionnaire - Min/Max: 0-100 (higher score means better outcome) |
| Change in Stress | 3-12 months | As assessed by The Perceived Stress Scale (PSS) questionnaire - Min/Max: 0-16 (higher score means worse outcome) |
| Change in Mood | 3-12 months | As assessed by The Patient Health Questionnaire (PHQ) questionnaire - Min/Max: 0-24 (higher score means worse outcome) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKayela Arrotta, PhD
The Cleveland Clinic
Outcome results
None listed