Clinical trial NCT05283200: Creating a Healthy L.I.F.E: Lifestyle Interventions For Epilepsy
Official title: Creating a Healthy L.I.F.E: Lifestyle Interventions For Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lifestyle
Keywords: Epilepsy
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Seizure Frequency
timeFrame: 3-12 months from beginning of intervention
Secondary outcomes:
measure: Change in Stress
timeFrame: 3-12 months from beginning of intervention
measure: Change in Stress
timeFrame: 3-12 months from beginning of intervention
measure: Quality of Life with Epilepsy
timeFrame: 3-12 months from beginning of intervention
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Imad Najm, MD
role: PRINCIPAL_INVESTIGATOR
References: