Stress Management Intervention for Living With Epilepsy (SMILE)

Study Overview
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Brief Summary
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The study will examine whether a stress reduction intervention reduces the number of seizures in people with drug resistant epilepsy.

Detailed Description
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The study will examine whether a stress reduction intervention reduces the number of seizures in people with drug resistant epilepsy. In the proposed randomized controlled, double blind trial, the investigators will enroll subjects with frequent seizures, especially those who identify stress as a seizure precipitant. There is an observational phase (8-12 weeks) and a treatment phase (12 weeks). During the observational phase, subjects will be monitored multiple times daily via smart phone devices, in order to identify high risk days for seizures. In the treatment phase, subjects will be randomly assigned to one of two groups receiving different focused attention practices. These behavioral interventions will be administered daily with extra interventions applied on days of higher risk.

Official Title
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Pre-emptive Treatment in Epilepsy Using Electronic Diaries: Towards a New Frontier in Epilepsy Therapy

Conditions
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Epilepsy

Intervention / Treatment
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* Behavioral: Progressive muscle relaxation
* Behavioral: Sham exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and above English speaking Partial epilepsy consistent with ILAE criteria supported by either EEG or MRI data Experiencing at least 2 seizures/month Reported awareness of all seizures, including seizures in a cluster One of the following: Patient-reported ability to self-predict seizures Patient-reported awareness of trigger factors, including stress Patient-reported awareness of premonitory features Able to maintain accurate e-diary independently Minimum 6th grade reading level as screened by WRAT administration Must be on a stable dose of anti-epileptic drugs for at least 30 days prior to study entry May be on stable dose of SSRI, SNRI, or atypical antipsychotic for at least 6 months May be on a stable dose of benzodiazepines (if so, dose stable for at least 30 days prior to study entry) For inclusion in clinical trial phase, patient must be/have: A minimum of 4 seizures documented in the 8-week baseline phase (or 6 seizures in the 12-week extended baseline phase) At least 1 seizure per 4-week period in two of the three 4-week periods in the extended baseline phase Diaries satisfactorily completed during baseline phase Complied with study requirements during the baseline phase Exclusion Criteria: Non-motor simple partial seizures only Concurrent VNS use History of suicide attempt within the past 2 years Current suicidality Not competent to sign consent Status epilepticus within the previous 6 months Began regularly using behavioral techniques for stress reduction within past 3 months Did not benefit from an adequate trial of a valid stress reduction technique Progressive neurologic condition that the investigator believes would affect seizure frequency Any history of substance abuse within the previous 2 years History of poor medication compliance as judged by the investigator Psychiatric illness that requires change in medication dose Any medical or psychiatric condition that would impair reliable participation in the trial Intermittent use of benzodiazepines (if used for sleep, will be determined case by case)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Progressive muscle relaxation<br>Subjects practice a progressive muscle relaxation exercise for 15 minutes every AM and 5 minutes every PM | Behavioral: Progressive muscle relaxation<br>* Subjects practice a progressive muscle relaxation exercise for 15 minutes every AM and 5 minutes every PM Both groups will practice twice daily, one 15 minute practice in the AM and a 5 minute practice in the PM. An additional 5 minute mid-day practice will occur only when e-diary entries from experience sampling meet specific predetermined criteria.<br>|
| Sham Comparator: Sham exercise<br>Subjects practice a sham exercise consisting of focused attention activities | Behavioral: Sham exercise<br>* The focused attention practices will consist of one or more of the following components: movement of body parts, breathing exercises, and writing exercises. Both groups will practice twice daily, one 15 minute practice in the AM and a 5 minute practice in the PM. An additional 5 minute mid-day practice will occur only when e-diary entries from experience sampling meet specific predetermined criteria.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in seizure frequency |  | End of baseline and end of 12 week clinical trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, seizures, stress reduction