EpilepsySMILENCT01444183
Stress Management Intervention for Living With Epilepsy (SMILE)
A study testing Progressive muscle relaxation in people with Epilepsy, run by Montefiore Medical Center at 3 sites in United States.
Trial summary
The study will examine whether a stress reduction intervention reduces the number of seizures in people with drug resistant epilepsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Progressive muscle relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2012to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 19Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Cincinnati
Cincinnati, Ohio, 45267
University of California San Francisco
San Francisco, California, 94143
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Pre-emptive Treatment in Epilepsy Using Electronic Diaries: Towards a New Frontier in Epilepsy Therapy
The study will examine whether a stress reduction intervention reduces the number of seizures in people with drug resistant epilepsy.
Read the detailed 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.
- Conditions
- Epilepsy
- Being tested
- Progressive muscle relaxation, Sham exercise
- Keywords
- Epilepsy, seizures, stress reduction
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive muscle relaxationBehavioural
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 exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Progressive muscle relaxation | Active comparator | Subjects practice a progressive muscle relaxation exercise for 15 minutes every AM and 5 minutes every PM Receives: Behavioral: Progressive muscle relaxation |
| Sham exercise | Sham comparator | Subjects practice a sham exercise consisting of focused attention activities Receives: Behavioral: Sham exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in seizure frequency
Measured: End of baseline and end of 12 week clinical trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Charles L Shor Foundation for Epilepsy Research, University of Cincinnati
- Responsible party
- Principal investigator, Sheryl Haut, Montefiore Medical Center
- Investigators
- Sheryl Haut, MD, Principal investigator, Montefiore Medical CenterMichael Privitera, MD, Principal investigator, University of CincinnatiSusannah Cornes, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444183
- Sponsor's protocol ID
- 11-07-296E
- Acronym
- SMILE
- Status last verified
- Apr 2015
- First submitted
- 15 Sep 2011
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19138755Haut SR, Hall CB, Masur J, Lipton RB. Seizure occurrence: precipitants and prediction. Neurology. 2007 Nov 13;69(20):1905-10. doi: 10.1212/01.wnl.0000278112.48285.84.
PubMed 17998482Heron 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.
PubMed 19646331Nickel 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. doi: 10.1016/j.jpsychores.2005.04.008.
PubMed 16310021Privitera M, Haut SR, Lipton RB, McGinley JS, Cornes S. Seizure self-prediction in a randomized controlled trial of stress management. Neurology. 2019 Nov 26;93(22):e2021-e2031. doi: 10.1212/WNL.0000000000008539. Epub 2019 Oct 23.
PubMed 31645468Haut SR, Lipton RB, Cornes S, Dwivedi AK, Wasson R, Cotton S, Strawn JR, Privitera M. Behavioral interventions as a treatment for epilepsy: A multicenter randomized controlled trial. Neurology. 2018 Mar 13;90(11):e963-e970. doi: 10.1212/WNL.0000000000005109. Epub 2018 Feb 14.
PubMed 29444968
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-emptive Treatment in Epilepsy Using Electronic Diaries: Towards a New Frontier in Epilepsy Therapy
- ClinicalTrials.gov ID
- NCT01444183
- Acronym / sponsor ID
- SMILE / 11-07-296E
- Conditions
- Epilepsy
- Keywords
- Epilepsy, seizures, stress reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Charles L Shor Foundation for Epilepsy Research, University of Cincinnati
- Study start
- Jan 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will examine whether a stress reduction intervention reduces the number of seizures in people with drug resistant epilepsy.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive muscle relaxation | Active comparator | Behavioral: Progressive muscle relaxationSubjects practice a progressive muscle relaxation exercise for 15 minutes every AM and 5 minutes every PM |
| Sham exercise | Sham comparator | Behavioral: Sham exerciseSubjects practice a sham exercise consisting of focused attention activities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive muscle relaxationSubjects 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. | Behavioural | Progressive muscle relaxation |
| Sham exerciseThe 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. | Behavioural | Sham exercise |
Primary outcome
Change in seizure frequency
Time frame: End of baseline and end of 12 week clinical trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Background: PubMed 19138755Hall 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.
- Background: PubMed 17998482Haut SR, Hall CB, Masur J, Lipton RB. Seizure occurrence: precipitants and prediction. Neurology. 2007 Nov 13;69(20):1905-10. doi: 10.1212/01.wnl.0000278112.48285.84.
- Background: PubMed 19646331Heron 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.
- Background: PubMed 16310021Nickel 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. doi: 10.1016/j.jpsychores.2005.04.008.
- Derived from this study: PubMed 31645468Privitera M, Haut SR, Lipton RB, McGinley JS, Cornes S. Seizure self-prediction in a randomized controlled trial of stress management. Neurology. 2019 Nov 26;93(22):e2021-e2031. doi: 10.1212/WNL.0000000000008539. Epub 2019 Oct 23.
- Derived from this study: PubMed 29444968Haut SR, Lipton RB, Cornes S, Dwivedi AK, Wasson R, Cotton S, Strawn JR, Privitera M. Behavioral interventions as a treatment for epilepsy: A multicenter randomized controlled trial. Neurology. 2018 Mar 13;90(11):e963-e970. doi: 10.1212/WNL.0000000000005109. Epub 2018 Feb 14.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheryl Haut, MD principal investigator
Montefiore Medical Center
Michael Privitera, MD principal investigator
University of Cincinnati
Susannah Cornes, MD principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive muscle relaxation in people with Epilepsy, run by Montefiore Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in seizure frequency (time frame: End of baseline and end of 12 week clinical trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01444183, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.