NCT01159431|CompletedPhase 2ResultsDMC
External Trigeminal Nerve Stimulation for Epilepsy
Randomized Double Blind Study of External Trigeminal Nerve Stimulation for Intractable Epilepsy
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Sponsor study identifier
interventional
50
1 country
2
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2011
Actual (reported)Study Completion
June 2011
Actual (reported)This study investigates a new therapy for epilepsy called Trigeminal Nerve Stimulation (TNS). TNS involves external electrical stimulation of sensory nerve located above the eyes and over the forehead. The purpose of this study is to determine if TNS is safe and effective using a rigorous randomized active-control clinical trial design in 50 people with epilepsy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
July 7, 2010
Actual (reported)July 9, 2010
Actual (reported)June 2011
Actual (reported)June 2011
Actual (reported)June 3, 2013
Actual (reported)50% Responder Rate
Change in responder rate, at end of study (18 weeks) Absolute percent of subjects with 50% reduction in seizures, 18 weeks compared with 6 weeks Note, the number is not a mean or median, but a fixed percentage.
Treatment period, 18 weeks (end of double blind period) compared with first 6 weeks
Time to the 4th Seizure
Number of Days to the 4th seizure
treatment period (18-weeks)
Change in Seizure Frequency
Percent change in seizure frequency from baseline
18 weeks
Response Ratio: Mean Percent Change in Seizures
18 weeks
Mood
18-weeks
External stimulation of the supraorbital branch of the Trigeminal Nerve using a digital TENs unit
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
USC Department of Neurology
Los Angeles, California, 90033, United States
Olive View/UCLA Medical Center
Sylmar, California, 91342, United States
DeGiorgio CM, Murray D, Markovic D, Whitehurst T. Trigeminal nerve stimulation for epilepsy: long-term feasibility and efficacy. Neurology. 2009 Mar 10;72(10):936-8. doi: 10.1212/01.wnl.0000344181.97126.b4. No abstract available.
DeGiorgio CM, Soss J, Cook IA, Markovic D, Gornbein J, Murray D, Oviedo S, Gordon S, Corralle-Leyva G, Kealey CP, Heck CN. Randomized controlled trial of trigeminal nerve stimulation for drug-resistant epilepsy. Neurology. 2013 Feb 26;80(9):786-91. doi: 10.1212/WNL.0b013e318285c11a. Epub 2013 Jan 30.
Due to sample size and high variability in seizure frequency, median change did not achieve significance. To constrain variability, the RRATIO was used to assess seizure frequency. The RRATIO demonstrated within groups differences, p=0.04 ANOVA.
Christopher M DeGiorgio, MD
University of California, Los Angeles
Christi Heck, MD
University of Southern California
50 participants (actual enrollment reported by the registry).
First Submitted
July 7, 2010
First Posted
July 9, 2010
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Study Evaluating the Pharmacokinetics of Keppra Extended Release (XR) in Children and Adults With Epilepsy
Contact the study team to confirm eligibility.
Primary Completion
June 2011
Actual (reported)Study Completion
June 2011
Actual (reported)Last Updated
June 3, 2013
Results First Posted
June 3, 2013
Record last verified: 2013-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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