Stress Management Intervention for Living With Epilepsy (SMILE)

Epilepsy Clinical Trial

— SMILE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444183
• Other study ID #: 11-07-296E
• Status: Completed
• Phase: N/A
• First received: September 15, 2011
• Last updated: April 17, 2018
• Start date: January 2012
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Epilepsy

Intervention

Behavioral:
• Progressive muscle relaxation
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.
• Sham exercise
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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	University of Cincinnati	Cincinnati	Ohio
United States	University of California San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Montefiore Medical Center	Charles L Shor Foundation for Epilepsy Research, University of Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (4)

Hall CB, Lipton RB, Tennen H, Haut SR. Early follow-up data from seizure diaries can be used to predict subsequent seizures in same cohort by borrowing strength across participants. Epilepsy Behav. 2009 Mar;14(3):472-5. doi: 10.1016/j.yebeh.2008.12.011. Epub 2009 Jan 10. — View Citation

Haut SR, Hall CB, Masur J, Lipton RB. Seizure occurrence: precipitants and prediction. Neurology. 2007 Nov 13;69(20):1905-10. — View Citation

Heron KE, Smyth JM. Ecological momentary interventions: incorporating mobile technology into psychosocial and health behaviour treatments. Br J Health Psychol. 2010 Feb;15(Pt 1):1-39. doi: 10.1348/135910709X466063. Epub 2009 Jul 28. Review. — View Citation

Nickel C, Kettler C, Muehlbacher M, Lahmann C, Tritt K, Fartacek R, Bachler E, Rother N, Egger C, Rother WK, Loew TH, Nickel MK. Effect of progressive muscle relaxation in adolescent female bronchial asthma patients: a randomized, double-blind, controlled study. J Psychosom Res. 2005 Dec;59(6):393-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in seizure frequency		End of baseline and end of 12 week clinical trial