At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
Trigeminal Nerve Stimulationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Double Blind Study of External Trigeminal Nerve Stimulation for Intractable Epilepsy
Olive View-UCLA Education & Research Institute·interventional·Posted Jul 9, 2010·Updated Jun 3, 2013
In Brief
A Phase 2 clinical trial evaluating Trigeminal Nerve Stimulation for Epilepsy and Seizure Disorders. Completed, enrolled 50 participants across 2 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Seizure Disorders
CountriesUnited States
CollaboratorsEpilepsy Foundation, Boston Scientific Corporation
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedJul 2010
Primary CompletionJun 2011
TodayJul 2026
First PostedJul 9, 2010
Enrollment StartJan 1, 2008
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 16.0 years ago
Interventions
Trigeminal Nerve Stimulationdevice
External stimulation of the supraorbital branch of the Trigeminal Nerve using a digital TENs unit