Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01444183
Other study ID # 11-07-296E
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04595513 - Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants Phase 1/Phase 2
Completed NCT02909387 - Adapting Project UPLIFT for Blacks in Georgia N/A
Completed NCT05552924 - Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients N/A
Terminated NCT01668654 - Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS Phase 3
Not yet recruiting NCT05068323 - Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients N/A
Completed NCT03994718 - Creative Arts II Study N/A
Recruiting NCT04076449 - Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
Completed NCT00782249 - Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy N/A
Completed NCT03683381 - App-based Intervention for Treating Insomnia Among Patients With Epilepsy N/A
Recruiting NCT05101161 - Neurofeedback Using Implanted Deep Brain Stimulation Electrodes N/A
Active, not recruiting NCT06034353 - Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients N/A
Recruiting NCT05769933 - Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
Not yet recruiting NCT06408428 - Glioma Intraoperative MicroElectroCorticoGraphy N/A
Not yet recruiting NCT05559060 - Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)
Completed NCT02952456 - Phenomenological Approach of Epilepsy in Patients With Epilepsy
Completed NCT02977208 - Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use Phase 4
Completed NCT02646631 - Behavioral and Educational Tools to Improve Epilepsy Care N/A
Recruiting NCT02539134 - TAK-935 Multiple Rising Dose Study in Healthy Participants Phase 1
Terminated NCT02757547 - Transcranial Magnetic Stimulation for Epilepsy N/A
Completed NCT02491073 - Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL) N/A