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

Lifestyle Clinical Trial

— LIFE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05283200
• Other study ID #: IRB 21-975
• Status: Recruiting
• Phase: N/A
• Start date: February 11, 2022
• Est. completion date: June 2026

Study information

• Verified date: June 2024
• Source: The Cleveland Clinic
• Contact: Arden Bischof, MS
• Phone: 216-444-3652
• Email: bischoa2[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Lifestyle

Intervention

Behavioral:
• Yoga
Yoga instructor will teach gentle yoga focused on meditation, breathing exercises, and mindfulness techniques to promote well-being and stress reduction
• Cognitive Behavioral Therapy
Psychologist will provide patients with psycho-educational and behavioral health strategies to promote seizure prevention and stress management skills
• Music
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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Imad Najm MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure Frequency	Reduction in seizure frequency	3-12 months from beginning of intervention
Secondary	Change in Stress	Change in stress as measured by improvement on the Patient Health Questionnaire-8.	3-12 months from beginning of intervention
Secondary	Change in Stress	Change in stress as measured by improvement on the Generalized Anxiety Disorder 7 scales.	3-12 months from beginning of intervention
Secondary	Quality of Life with Epilepsy	Change in reported Quality of Life as measured by improvement in the Quality of Life in Epilepsy assessment.	3-12 months from beginning of intervention