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

Not Applicable

Recruiting

• Conditions: Lifestyle

• Registration Number: NCT05283200
• Lead Sponsor: Imad Najm MD

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.

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

Study Timeline

• Study Start: 2022-02-11
• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-16
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10
• Primary Completion: 2026-02
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Seizure Frequency	3-12 months from beginning of intervention	Reduction in seizure frequency

Secondary Outcome Measures

Name	Time	Method
Change in Stress	3-12 months from beginning of intervention	Change in stress as measured by improvement on the Generalized Anxiety Disorder 7 scales.
Quality of Life with Epilepsy	3-12 months from beginning of intervention	Change in reported Quality of Life as measured by improvement in the Quality of Life in Epilepsy assessment.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States