Lifestyle interventions for epilepsy management

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

This study tests whether lifestyle changes like therapy, yoga, or music can help adults with epilepsy who don't respond to medication by reducing their seizures and improving their overall well-being.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Cleveland Clinic (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT05283200 on ClinicalTrials.gov

What this trial studies

This study examines the effects of behavioral and wellness-based interventions on seizure frequency in adults with medication-resistant epilepsy. Participants will be randomly assigned to receive cognitive behavioral therapy, yoga therapy, or music therapy, while control groups will continue their standard care. The study aims to measure outcomes such as seizure frequency, stress levels, cognitive function, and quality of life through various assessments and questionnaires. Additionally, human biospecimens will be collected for future research on the biological impact of these interventions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a confirmed diagnosis of epilepsy who experience at least one seizure per month and are willing to participate in the interventions.

Not a fit: Patients with non-epileptic seizures or those who have recently engaged in similar therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new non-pharmacological treatment options for patients with difficult-to-treat epilepsy.

How similar studies have performed: While there have been studies exploring lifestyle interventions for epilepsy, this specific combination of therapies is novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Imad Najm, MD — The Cleveland Clinic
• Study coordinator: Arden Bischof, MS

Conditions: Lifestyle, Epilepsy