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Lifestyle Interventions for Epilepsy (LIFE Trial)

N/A

Recruiting

Led By Imad Najm, MD

Research Sponsored by Imad Najm MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to independently provide informed consent

Adult (ages 18-75) patients of the Cleveland Clinic Charles Shor Epilepsy Center with a confirmed diagnosis of epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-12 months from beginning of intervention

Awards & highlights

LIFE Trial Summary

This trial will test if behavior and wellness interventions can reduce seizure frequency for adult patients with medication resistant epilepsy.

Who is the study for?

Adults aged 18-75 with medication-resistant epilepsy, experiencing at least one seizure a month, can join this study. They must be able to consent and participate in yoga, music therapy or CBT without changing their seizure meds. Excluded are those with non-epileptic seizures, recent similar therapy, other trials' participation, serious chronic illnesses that affect safety in the study, intensive treatments like chemotherapy, pregnancy/postpartum status within six weeks.Check my eligibility

What is being tested?

The trial is testing if yoga, cognitive behavioral therapy (CBT), or music can help reduce seizures in adults who don't respond well to epilepsy drugs. Participants will be randomly assigned to one of these interventions and monitored for changes in their seizure frequency.See study design

What are the potential side effects?

Since the interventions involve lifestyle changes such as yoga and music therapy rather than medications there may not be typical side effects; however participants might experience muscle soreness from physical activity or emotional discomfort during CBT.

LIFE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can understand and agree to the study on my own.

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I am between 18 and 75 years old and have been diagnosed with epilepsy by the Cleveland Clinic.

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I don't expect to change my seizure medication soon.

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I have had at least one seizure in the last 30 days.

LIFE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-12 months from beginning of intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-12 months from beginning of intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-12 months from beginning of intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Seizures

Secondary outcome measures

Change in Stress

Quality of Life with Epilepsy

Side effects data

From 2021 Phase 4 trial • 12 Patients • NCT04135937

irritability

100%

80%

60%

40%

20%

Study treatment Arm

MESH

LIFE Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: YogaExperimental Treatment1 Intervention

The goal for the yoga intervention is to provide participants with instructor-guided safe, gentle yoga focused on meditation, breathing exercises, and mindfulness techniques to promote well-being and stress reduction. We aim for participants to utilize the skills and strategies taught through this intervention to reduce seizure frequency, anxiety symptoms, disability, and improve quality of life. Participants enrolled in the Yoga intervention group will receive one month of Instructor-Guided 70-minute virtual live yoga classes, twice per week, led by an experienced yoga therapist and co-instructor. During Months 2-3 participants in the Yoga Intervention will receive one 70-minute virtual live yoga class per week. Each session will have a set of specific poses, breathing exercises, meditation, and yoga philosophies developed by our yoga experts.

Group II: MusicExperimental Treatment1 Intervention

The aim of this intervention is for participants to learn and develop skills to reduce stress which may, in turn, decrease seizure frequency and improve quality of life. Participants will be exposed to a variety of ways that they might incorporate music into their daily lives as a means of self-expression, coping, and stress reduction. Participants enrolled in the Music Intervention group will receive one month of Instructor-Guided Intervention 70-minute virtual live music therapy sessions, twice per week, led by an experienced music therapist and co-instructor. An two months of a 70-minute virtual live music therapy session once per week.

Group III: Cognitive Behavioral TherapyExperimental Treatment1 Intervention

The goal of the Cognitive Behavioral Therapy (CBT) intervention is to provide patients with psycho-educational and behavioral health strategies to promote seizure prevention and stress management skills. We aim for participants to utilize the skills and strategies taught through this intervention to reduce seizure frequency, depression and anxiety symptoms, disability and improve quality of life. Participants enrolled in the CBT intervention group will receive 3 months of Instructor-Guided 90-minute, virtual group counseling session, once per week, led by a psychologist and a co-therapist.

Group IV: Standard of CareActive Control1 Intervention

Participants randomized to the Standard of Care Control Group will receive their usual standard epilepsy care. Participants will receive a brief monthly call for checking-in and collection of seizure frequency. Upon completion of the study, participants will receive access to online materials for all intervention modalities if they wish.

Group V: Enhanced Standard of CareActive Control1 Intervention

Participants randomized to the Enhanced Standard of Care Control Group will receive their usual standard epilepsy care and weekly scheduled, scripted, follow-up phone calls from a study team member to check-in on their health, epilepsy management, and seizure frequency. Upon completion of the study, participants will receive access to online materials for all intervention modalities if they wish.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Yoga

2008

Completed Phase 3

~3830

Cognitive Behavioral Therapy

2016

Completed Phase 4

~3120

Music

2013

Completed Phase 3

~1810

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Imad Najm MDLead Sponsor

The Cleveland ClinicLead Sponsor

1,033 Previous Clinical Trials

1,364,384 Total Patients Enrolled

Imad Najm, MDPrincipal InvestigatorThe Cleveland Clinic

Media Library

Cognitive Behavioral Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05283200 — N/A

Lifestyle Research Study Groups: Yoga, Cognitive Behavioral Therapy, Music, Standard of Care, Enhanced Standard of Care

Lifestyle Clinical Trial 2023: Cognitive Behavioral Therapy Highlights & Side Effects. Trial Name: NCT05283200 — N/A

Cognitive Behavioral Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05283200 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this trial open to individuals below the age of 40?

"This research initiative is recruiting anyone aged between 18 and 75 who wishes to participate."

Answered by AI

Are there any current openings for participants in this research?

"Assessing the information provided by clinicaltrials.gov, we can see that this trial is currently recruiting patients and has been since February 11th 2022. The study's details were last updated on June 22nd 2022."

Answered by AI

Is an individual able to partake in this experiment?

"To qualify for this trial, subjects must be aged between 18 and 75 with a healthy lifestyle. Ultimately, 1000 individuals need to be enrolled in the study."

Answered by AI

How many test subjects are being recruited for this experiment?

"Affirmative, according to clinicaltrials.gov this medical trial is presently recruiting individuals. This research was first published on February 11th 2022 and has been updated as recently as June 22nd 2022. The study seeks a thousand participants from one centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Imad Najm MD 2022. "Creating a Healthy L.I.F.E: Lifestyle Interventions For Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05283200.

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