Health TrialsbyHealthPanel

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

ConditionEpilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorKayela Arrotta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Cognitive InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

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)

Time frame
3-12 months from the beginning of the intervention

Secondary outcomes

1

Change in Cognitive function

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)

Time frame
3-12 months
2

Change in Quality of Life

As assessed by The Quality of Life in Epilepsy (QOLIE) questionnaire - Min/Max: 0-100 (higher score means better outcome)

Time frame
3-12 months
3

Change in Stress

As assessed by The Perceived Stress Scale (PSS) questionnaire - Min/Max: 0-16 (higher score means worse outcome)

Time frame
3-12 months
4

Change in Mood

As assessed by The Patient Health Questionnaire (PHQ) questionnaire - Min/Max: 0-24 (higher score means worse outcome)

Time frame
3-12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kayela Arrotta

Lead sponsor

The Cleveland Clinic

Sponsor institution

Source ClinicalTrials.gov
Apply now