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

NCT05283200 | Active Not Recruiting

• 1 other identifier: IRB 21-975
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Lifestyle

Keywords

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Seizure Frequency

  Reduction in seizure frequency

  3-12 months from beginning of intervention

Secondary Outcomes (3)

• Change in Stress

  3-12 months from beginning of intervention

• Change in Stress

  3-12 months from beginning of intervention

• Quality of Life with Epilepsy

  3-12 months from beginning of intervention

Study Arms (5)

Yoga

EXPERIMENTAL

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

Cognitive Behavioral Therapy

EXPERIMENTAL

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

Music

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Enhanced Standard of Care

NO INTERVENTION

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.

Interventions

Yoga BEHAVIORAL

Yoga instructor will teach gentle yoga focused on meditation, breathing exercises, and mindfulness techniques to promote well-being and stress reduction

Yoga

Cognitive Behavioral Therapy BEHAVIORAL

Psychologist will provide patients with psycho-educational and behavioral health strategies to promote seizure prevention and stress management skills

Cognitive Behavioral Therapy

Music BEHAVIORAL

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.

Music

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imad Najm MD: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Yoga; Cognitive Behavioral Therapy; Music Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Sensory Art Therapies; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Imad Najm, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 16, 2022
• Study Start: February 11, 2022
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)