ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-11

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05283200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Imad Najm, MD

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Imad Najm MD

Imad Najm, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-11

Study Completion Date2026-06

Study Record Updates

Study Start Date2022-02-11

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

Epilepsy

Additional Relevant MeSH Terms

Lifestyle