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.
Poorly controlled epilepsy is a disabling condition, affecting over one million Americans. Neurostimulation is a promising alternative for patients who have failed medical therapy, and who are not resective surgical candidates. Trigeminal Nerve Stimulation (TNS) is a novel form of neurostimulation, and has a strong antiepileptic effect in an animal model of seizures. Preliminary data in humans indicates TNS is well tolerated and may be effective in people with intractable epilepsy. TNS is an alternative mode of neurostimulation, because the Trigeminal Nerve can be stimulated in minimally-invasive fashion. This is a randomized double blind study of Trigeminal Nerve Stimulation, which compares high stimulation to an active control. Subjects with poorly controlled partial onset seizures who meet all inclusion and exclusion criteria, enter a 6-week baseline period, and then are randomized in double-blind fashion to high or low intensity stimulation for 18 weeks. 50 subjects are to be enrolled at two sites. Study outcomes are the following: 1. Percent change in seizure frequency during the treatment period compared with the baseline (pre-treatment) period. 2. Time to the 4th seizure The primary comparisons will be between and within groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
External stimulation of the supraorbital branch of the Trigeminal Nerve using a digital TENs unit
USC Department of Neurology
Los Angeles, California, United States
Olive View/UCLA Medical Center
Sylmar, California, United States
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.
Time frame: 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
Time frame: treatment period (18-weeks)
Change in Seizure Frequency
Percent change in seizure frequency from baseline
Time frame: 18 weeks
Response Ratio: Mean Percent Change in Seizures
Response Ratio: Mean Percent Change in seizures over the treatment period, where \[T-B\] / \[T+B\] x 100%, where T = seizure frequency during the treatment period, and B = seizure frequency during the baseline period.
Time frame: 18 weeks
Mood
Mean change in score on the Beck Depression Inventory. The Beck Inventory is a patient reported mood scale. The minimum score is 0, and the maximum score is 63. Scores of less than 10 are considered in the normal range. Scores above 10 are consistent with depression. Higher scores indicate higher degrees of depression, with scores of \> 25 consistent with severe depression.
Time frame: 18-weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.