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Active, not recruitingNCT05954182Updated Jul 27, 2026

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

An interventional study of Cognitive Intervention in Epilepsy, sponsored by Kayela Arrotta. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Kayela Arrotta · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Epilepsy

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03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's planned enrollment of 170 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Kayela Arrotta is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
170 participants (estimated)

Study arms

  • Experimental
    Cognitive Intervention

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

    Behavioral: Cognitive Intervention

  • No intervention
    Control

    Participants in this group will NOT receive the group sessions

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.

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What researchers measure

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

  5. Change in Mood

    As assessed by The Generalized Anxiety Disorder (GAD-7) questionnaire - Min/Max: 0-21 (higher score means worse outcome)

    Time frame: 3-12 months

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Study locations

1 site
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
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References and documents

Publications

  • Motamedi G, Meador K. Epilepsy and cognition. Epilepsy Behav. 2003 Oct;4 Suppl 2:S25-38. doi: 10.1016/j.yebeh.2003.07.004. PubMed 14527481 ↗
  • 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. PubMed 32208338 ↗
  • 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. PubMed 25524861 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05954182
Lead sponsor
Kayela Arrotta
Responsible party
Kayela Arrotta (Principal Investigator, The Cleveland Clinic) — Sponsor-investigator
First posted
Jul 20, 2023
Start date
Sep 20, 2023
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Jul 27, 2026

Study contacts

Kayela Arrotta, PhD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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