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

Primary Purpose

Epilepsy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Intervention
Sponsored by
Kayela Arrotta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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 Objective cognitive deficits as determined by a cognitive screening measure (Brief Assessment of Cognitive Health [BACH]) 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 epilepsy surgery Willing and able to participate in cognitive intervention Exclusion Criteria: Patients with a history 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 or current application for long term disability 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

Sites / Locations

  • Cleveland ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Intervention

Control

Arm Description

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

Participants in this group will NOT receive the group sessions

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
Change in Stress
As assessed by The Perceived Stress Scale (PSS) questionnaire - Min/Max: 0-16 (higher score means worse outcome)
Change in Mood
As assessed by The Patient Health Questionnaire (PHQ) questionnaire - Min/Max: 0-24 (higher score means worse outcome)
Change in Mood
As assessed by The Generalized Anxiety Disorder (GAD-7) questionnaire - Min/Max: 0-21 (higher score means worse outcome)

Full Information

First Posted
June 30, 2023
Last Updated
October 6, 2023
Sponsor
Kayela Arrotta
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1. Study Identification

Unique Protocol Identification Number
NCT05954182
Brief Title
Cognitive Enhancement Intervention for Creating a Healthy L.I.F.E (Lifestyle Interventions for Epilepsy)
Official Title
Cognitive Enhancement Intervention for Creating a Healthy L.I.F.E (Lifestyle Interventions for Epilepsy)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2023 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kayela Arrotta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Intervention
Arm Type
Experimental
Arm Description
Participants in this group will receive weekly, live, virtual group sessions for 12 weeks
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this group will NOT receive the group sessions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Intervention
Intervention Description
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 Outcome Measure Information:
Title
Change in Everyday Functioning
Description
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 Outcome Measure Information:
Title
Change in Cognitive function
Description
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
Title
Change in Quality of Life
Description
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
Title
Change in Stress
Description
As assessed by The Perceived Stress Scale (PSS) questionnaire - Min/Max: 0-16 (higher score means worse outcome)
Time Frame
3-12 months
Title
Change in Mood
Description
As assessed by The Patient Health Questionnaire (PHQ) questionnaire - Min/Max: 0-24 (higher score means worse outcome)
Time Frame
3-12 months
Title
Change in Mood
Description
As assessed by The Generalized Anxiety Disorder (GAD-7) questionnaire - Min/Max: 0-21 (higher score means worse outcome)
Time Frame
3-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Objective cognitive deficits as determined by a cognitive screening measure (Brief Assessment of Cognitive Health [BACH]) 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 epilepsy surgery Willing and able to participate in cognitive intervention Exclusion Criteria: Patients with a history 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 or current application for long term disability 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Lioi, PhD
Phone
216-444-5666
Email
lioia2@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kayela Arrotta, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Lioi, PhD
Phone
216-444-5666
Email
lioia2@ccf.org
First Name & Middle Initial & Last Name & Degree
Kayela Arrotta, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
14527481
Citation
Motamedi G, Meador K. Epilepsy and cognition. Epilepsy Behav. 2003 Oct;4 Suppl 2:S25-38. doi: 10.1016/j.yebeh.2003.07.004.
Results Reference
background
PubMed Identifier
32208338
Citation
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.
Results Reference
background
PubMed Identifier
25524861
Citation
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.
Results Reference
background

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

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