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| Name | Class |
|---|---|
| Charles L Shor Foundation for Epilepsy Research | UNKNOWN |
| University of Cincinnati | OTHER |
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The study will examine whether a stress reduction intervention reduces the number of seizures in people with drug resistant epilepsy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progressive muscle relaxation | Active Comparator | Subjects practice a progressive muscle relaxation exercise for 15 minutes every AM and 5 minutes every PM |
|
| Sham exercise | Sham Comparator | Subjects practice a sham exercise consisting of focused attention activities |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progressive muscle relaxation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in seizure frequency | End of baseline and end of 12 week clinical trial |
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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:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheryl Haut, MD | Montefiore Medical Center | Principal Investigator |
| Michael Privitera, MD | University of Cincinnati | Principal Investigator |
| Susannah Cornes, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States | ||
| Montefiore Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19138755 | Background | 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. | |
| 17998482 | Background | Haut 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. |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D001326 | Autogenic Training |
| ID | Term |
|---|---|
| D006990 | Hypnosis |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| Sham exercise | Behavioral | 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. |
|
| The Bronx |
| New York |
| 10467 |
| United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| 19646331 | Background | 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. |
| 16310021 | Background | 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. doi: 10.1016/j.jpsychores.2005.04.008. |
| 31645468 | Derived | Privitera 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. |
| 29444968 | Derived | Haut 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |