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Active, Not Recruiting

NCT Number: NCT05954182

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Everyday Functioning

    Time frame: 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 outcomes

  1. Change in Cognitive function

    Time frame: 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)

  2. Change in Quality of Life

    Time frame: 3-12 months

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

  3. Change in Stress

    Time frame: 3-12 months

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

  4. Change in Mood

    Time frame: 3-12 months

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

  5. Change in Mood

    Time frame: 3-12 months

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

Sponsors and collaborators

Lead sponsor

Kayela Arrotta

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2023
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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