Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Stress Management Intervention for Living With Epilepsy (SMILE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Charles L Shor Foundation for Epilepsy Research
University of Cincinnati
Information provided by (Responsible Party):
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01444183
First received: September 15, 2011
Last updated: October 2, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Epilepsy
Behavioral: Focused Attention A
Behavioral: Focused Attention B
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pre-emptive Treatment in Epilepsy Using Electronic Diaries: Towards a New Frontier in Epilepsy Therapy

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Change in seizure frequency [ Time Frame: End of baseline and end of 12 week clinical trial ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Focused Attention A Behavioral: Focused Attention A

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.

Sham Comparator: Focused Attention B Behavioral: Focused Attention B

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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

    1. Patient-reported ability to self-predict seizures
    2. Patient-reported awareness of trigger factors, including stress
    3. 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444183

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
Montefiore Medical Center
Charles L Shor Foundation for Epilepsy Research
University of Cincinnati
Investigators
Principal Investigator: Sheryl Haut, MD Montefiore Medical Center
Principal Investigator: Michael Privitera, MD University of Cincinnati
Principal Investigator: Susannah Cornes, MD University of California, San Francisco