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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lifestyle
• Intervention / Treatment: Behavioral: Yoga; Behavioral: Cognitive Behavioral Therapy; Behavioral: Music

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.

The CBT arm is currently closed to enrollment as of 8/14/2023.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult (ages 18-75) patients of the Cleveland Clinic 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 or music therapy

Exclusion Criteria:

• Patients with a history of non-epileptic or psychogenic seizures
• Any patient that has engaged in yoga or music therapy 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 participate in the study safely or effectively.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yoga; 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.	Behavioral: Yoga; Yoga instructor will teach gentle yoga focused on meditation, breathing exercises, and mindfulness techniques to promote well-being and stress reduction
Experimental: Cognitive Behavioral Therapy; 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.	Behavioral: Cognitive Behavioral Therapy; Psychologist will provide patients with psycho-educational and behavioral health strategies to promote seizure prevention and stress management skills
Experimental: Music; 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.	Behavioral: Music; 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.
No Intervention: Enhanced Standard of Care; 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.
No Intervention: Standard of Care; Participants randomized to the Standard of Care Control Group will receive their usual standard epilepsy care. For Months 1-3 participants will receive weekly online surveys as well as brief monthly calls checking-in and collecting their seizure frequency. Participants will continue to receive brief monthly calls for checking-in and collection of seizure frequency Months 4-12. Upon completion of the study, participants will receive access to online materials for all intervention modalities if they wish.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure Frequency	Reduction in seizure frequency	3-12 months from beginning of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Stress	Change in stress as measured by improvement on the Patient Health Questionnaire-8.	3-12 months from beginning of intervention
Change in Stress	Change in stress as measured by improvement on the Generalized Anxiety Disorder 7 scales.	3-12 months from beginning of intervention
Quality of Life with Epilepsy	Change in reported Quality of Life as measured by improvement in the Quality of Life in Epilepsy assessment.	3-12 months from beginning of intervention

Collaborators and Investigators

• Sponsor: Imad Najm MD
• Investigators: Principal Investigator: Imad Najm, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2022
• Primary Completion (Actual): February 28, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Epilepsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Therapeutics; Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Patient Care; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Sensory Art Therapies; Yoga; Cognitive Behavioral Therapy; Music Therapy
• Other Study ID Numbers: IRB 21-975

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patient identifiers will be removed and a unique number will be assigned to each subject/specimen. Paper records will be stored in locked filing cabinets and access will be limited to the study PIs and designated research coordinators. Coded specimens will be stored in secured laboratories in locked freezers at CCF. Electronic subject data may be stored with restricted access. Clinical data will be maintained in a password protected REDCap database with restricted access limited to the named study investigators, and personal health information will be flagged.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No