Phase 2
N=50
External Trigeminal Nerve Stimulation for Epilepsy
Epilepsy · Seizure Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01159431 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Jun 2013
Primary outcome: Primary: 50% Responder Rate — 40.5; 15.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Trigeminal Nerve Stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Olive View-UCLA Education & Research Institute
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 50% Responder Rate |
40.5; 15.6 | — |
| PRIMARY Time to the 4th Seizure |
23; 18; 12.5; 15 | — |
| PRIMARY Change in Seizure Frequency |
-16.1; -10.5 | — |
| SECONDARY Response Ratio: Mean Percent Change in Seizures |
-13.9; -9.0 | — |
| SECONDARY Mood |
-8.13; -3.95 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Ages 18 - 70;
- No serious or progressive medical illness;
- A history of intractable partial seizures;
- At least two complex partial or tonic clonic generalized seizures per month in the last two consecutive months;
- MRI or EEG consistent with localization-related or partial epilepsy;
- Exposure to at least two antiepileptic drugs at adequate doses;
- Concurrent use of at least one antiepileptic drug at adequate doses;
- No change in antiepileptic dose for at least 30 days before study enrollment
Exclusion Criteria
- History of non-epileptic seizures;
- Inability to maintain accurate seizure calendars (self or caregiver);
- Frequent use of benzodiazepines for clusters defined as greater than four times a month;
- History of facial pain or trigeminal neuralgia;
- Concurrent vagus nerve stimulation;
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT01159431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.