Status:
ACTIVE_NOT_RECRUITING
Creating a Healthy L.I.F.E: Lifestyle Interventions For Epilepsy
Lead Sponsor:
Imad Najm MD
Conditions:
Lifestyle
Eligibility:
All Genders
18-75 years
Phase:
NA
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 stil...
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), stre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05283200
Start Date
February 11 2022
End Date
June 1 2026
Last Update
October 23 2025
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195