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Creating a Healthy L.I.F.E: Lifestyle Interventions For Epilepsy (LIFE)

Primary Purpose

Lifestyle

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Cognitive Behavioral Therapy
Music
Sponsored by
Imad Najm MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lifestyle focused on measuring Epilepsy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult (ages 18-75) patients of the Cleveland Clinic Charles Shor Epilepsy Center with a confirmed diagnosis of epilepsy
  • Ability to independently provide informed consent
  • At the time of enrollment, patients must have had at least 1 seizure within the past 30 days
  • No anticipated anti-seizure medication adjustments
  • Internet access and the ability to participate in online video streaming
  • Reading abilities at or above 8th grade level as determined by the Wide Range Achievement Test- 4th Edition (WRAT-4) Reading subtest
  • Willing and able to participate in any of the assigned interventions which may include yoga therapy, music therapy, or CBT

Exclusion Criteria:

  • Patients with a history of non-epileptic or psychogenic seizures
  • Any patient that has engaged in yoga, music therapy, or epilepsy-specific CBT within the last 6 months
  • 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
  • Participants with a diagnosed, symptomatic, chronic illness (i.e., significant psychiatric concerns, liver, gastrointestinal, respiratory, renal, cardiac, etc.) who, based on primary investigator review, will not be able to safely or effectively participate in the study.
  • Undergoing intensive medical treatment for serious or life-threatening illness (e.g., chemotherapy, etc.) that would impact study participation.
  • Currently pregnant or less than 6 weeks postpartum
  • Significant hearing loss
  • Blindness
  • Musicogenic epilepsy or seizures

Sites / Locations

  • Cleveland ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

No Intervention

No Intervention

Arm Label

Yoga

Cognitive Behavioral Therapy

Music

Standard of Care

Enhanced Standard of Care

Arm Description

The goal for the yoga intervention is to provide participants with instructor-guided safe, gentle yoga focused on meditation, breathing exercises, and mindfulness techniques to promote well-being and stress reduction. We aim for participants to utilize the skills and strategies taught through this intervention to reduce seizure frequency, anxiety symptoms, disability, and improve quality of life. Participants enrolled in the Yoga intervention group will receive one month of Instructor-Guided 70-minute virtual live yoga classes, twice per week, led by an experienced yoga therapist and co-instructor. During Months 2-3 participants in the Yoga Intervention will receive one 70-minute virtual live yoga class per week. Each session will have a set of specific poses, breathing exercises, meditation, and yoga philosophies developed by our yoga experts.

The goal of the Cognitive Behavioral Therapy (CBT) intervention is to provide patients with psycho-educational and behavioral health strategies to promote seizure prevention and stress management skills. We aim for participants to utilize the skills and strategies taught through this intervention to reduce seizure frequency, depression and anxiety symptoms, disability and improve quality of life. Participants enrolled in the CBT intervention group will receive 3 months of Instructor-Guided 90-minute, virtual group counseling session, once per week, led by a psychologist and a co-therapist.

The aim of this intervention is for participants to learn and develop skills to reduce stress which may, in turn, decrease seizure frequency and improve quality of life. Participants will be exposed to a variety of ways that they might incorporate music into their daily lives as a means of self-expression, coping, and stress reduction. Participants enrolled in the Music Intervention group will receive one month of Instructor-Guided Intervention 70-minute virtual live music therapy sessions, twice per week, led by an experienced music therapist and co-instructor. An two months of a 70-minute virtual live music therapy session once per week.

Participants randomized to the Standard of Care Control Group will receive their usual standard epilepsy care. Participants will receive a brief monthly call for checking-in and collection of seizure frequency. Upon completion of the study, participants will receive access to online materials for all intervention modalities if they wish.

Participants randomized to the Enhanced Standard of Care Control Group will receive their usual standard epilepsy care and weekly scheduled, scripted, follow-up phone calls from a study team member to check-in on their health, epilepsy management, and seizure frequency. Upon completion of the study, participants will receive access to online materials for all intervention modalities if they wish.

Outcomes

Primary Outcome Measures

Seizure Frequency
Reduction in seizure frequency

Secondary Outcome Measures

Change in Stress
Change in stress as measured by improvement on the Patient Health Questionnaire-8.
Change in Stress
Change in stress as measured by improvement on the Generalized Anxiety Disorder 7 scales.
Quality of Life with Epilepsy
Change in reported Quality of Life as measured by improvement in the Quality of Life in Epilepsy assessment.

Full Information

First Posted
February 11, 2022
Last Updated
June 30, 2023
Sponsor
Imad Najm MD
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1. Study Identification

Unique Protocol Identification Number
NCT05283200
Brief Title
Creating a Healthy L.I.F.E: Lifestyle Interventions For Epilepsy
Acronym
LIFE
Official Title
Creating a Healthy L.I.F.E: Lifestyle Interventions For Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2022 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Imad Najm MD

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
A prospective controlled, randomized study to examine the effects of behavioral and wellness-based interventions on seizure frequency for adult patients with medication resistant epilepsy who are still experiencing 1 or more seizures per month.
Detailed Description
In this prospective controlled, randomized study, investigators aim to assess the impact of integrative behavioral and wellness-based interventions on seizure frequency (primary outcome measure), stress, cognitive function, and quality of life (secondary outcome measures) in patients with difficult to treat epilepsy. The study team will accomplish these objectives through three active interventions that include: cognitive behavioral therapy (CBT), yoga therapy, and music therapy. This study will have two control groups who will continue with their standard of care as guided by their epilepsy provider. Investigators will measure the effects of our interventions using seizure diaries, cognitive assessments, and health and quality of life questionnaires. In this study, the study team will collect, process, store, and analyze human biospecimens of enrolled participants for research purposes to assess the potential biologic impact of our interventions. Collection, processing, storage, and data management of the biospecimens to be used for this study, and future studies, will be completed through Lerner Research Institute.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yoga
Arm Type
Experimental
Arm Description
The goal for the yoga intervention is to provide participants with instructor-guided safe, gentle yoga focused on meditation, breathing exercises, and mindfulness techniques to promote well-being and stress reduction. We aim for participants to utilize the skills and strategies taught through this intervention to reduce seizure frequency, anxiety symptoms, disability, and improve quality of life. Participants enrolled in the Yoga intervention group will receive one month of Instructor-Guided 70-minute virtual live yoga classes, twice per week, led by an experienced yoga therapist and co-instructor. During Months 2-3 participants in the Yoga Intervention will receive one 70-minute virtual live yoga class per week. Each session will have a set of specific poses, breathing exercises, meditation, and yoga philosophies developed by our yoga experts.
Arm Title
Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
The goal of the Cognitive Behavioral Therapy (CBT) intervention is to provide patients with psycho-educational and behavioral health strategies to promote seizure prevention and stress management skills. We aim for participants to utilize the skills and strategies taught through this intervention to reduce seizure frequency, depression and anxiety symptoms, disability and improve quality of life. Participants enrolled in the CBT intervention group will receive 3 months of Instructor-Guided 90-minute, virtual group counseling session, once per week, led by a psychologist and a co-therapist.
Arm Title
Music
Arm Type
Experimental
Arm Description
The aim of this intervention is for participants to learn and develop skills to reduce stress which may, in turn, decrease seizure frequency and improve quality of life. Participants will be exposed to a variety of ways that they might incorporate music into their daily lives as a means of self-expression, coping, and stress reduction. Participants enrolled in the Music Intervention group will receive one month of Instructor-Guided Intervention 70-minute virtual live music therapy sessions, twice per week, led by an experienced music therapist and co-instructor. An two months of a 70-minute virtual live music therapy session once per week.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Participants randomized to the Standard of Care Control Group will receive their usual standard epilepsy care. Participants will receive a brief monthly call for checking-in and collection of seizure frequency. Upon completion of the study, participants will receive access to online materials for all intervention modalities if they wish.
Arm Title
Enhanced Standard of Care
Arm Type
No Intervention
Arm Description
Participants randomized to the Enhanced Standard of Care Control Group will receive their usual standard epilepsy care and weekly scheduled, scripted, follow-up phone calls from a study team member to check-in on their health, epilepsy management, and seizure frequency. Upon completion of the study, participants will receive access to online materials for all intervention modalities if they wish.
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
Yoga instructor will teach gentle yoga focused on meditation, breathing exercises, and mindfulness techniques to promote well-being and stress reduction
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
Psychologist will provide patients with psycho-educational and behavioral health strategies to promote seizure prevention and stress management skills
Intervention Type
Behavioral
Intervention Name(s)
Music
Intervention Description
Music therapist will teach a variety of ways that participants might incorporate music into their daily lives as a means of self-expression, coping, and stress reduction.
Primary Outcome Measure Information:
Title
Seizure Frequency
Description
Reduction in seizure frequency
Time Frame
3-12 months from beginning of intervention
Secondary Outcome Measure Information:
Title
Change in Stress
Description
Change in stress as measured by improvement on the Patient Health Questionnaire-8.
Time Frame
3-12 months from beginning of intervention
Title
Change in Stress
Description
Change in stress as measured by improvement on the Generalized Anxiety Disorder 7 scales.
Time Frame
3-12 months from beginning of intervention
Title
Quality of Life with Epilepsy
Description
Change in reported Quality of Life as measured by improvement in the Quality of Life in Epilepsy assessment.
Time Frame
3-12 months from beginning of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (ages 18-75) patients of the Cleveland Clinic Charles Shor Epilepsy Center with a confirmed diagnosis of epilepsy Ability to independently provide informed consent At the time of enrollment, patients must have had at least 1 seizure within the past 30 days No anticipated anti-seizure medication adjustments Internet access and the ability to participate in online video streaming Reading abilities at or above 8th grade level as determined by the Wide Range Achievement Test- 4th Edition (WRAT-4) Reading subtest Willing and able to participate in any of the assigned interventions which may include yoga therapy, music therapy, or CBT Exclusion Criteria: Patients with a history of non-epileptic or psychogenic seizures Any patient that has engaged in yoga, music therapy, or epilepsy-specific CBT within the last 6 months 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 Participants with a diagnosed, symptomatic, chronic illness (i.e., significant psychiatric concerns, liver, gastrointestinal, respiratory, renal, cardiac, etc.) who, based on primary investigator review, will not be able to safely or effectively participate in the study. Undergoing intensive medical treatment for serious or life-threatening illness (e.g., chemotherapy, etc.) that would impact study participation. Currently pregnant or less than 6 weeks postpartum Significant hearing loss Blindness Musicogenic epilepsy or seizures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arden Bischof, MS
Phone
216-444-3652
Email
jacobsa19@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imad Najm, MD
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
Cleveland Clinic
First Name & Middle Initial & Last Name & Degree
Imad Najm, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Creating a Healthy L.I.F.E: Lifestyle Interventions For Epilepsy

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