Trigeminal Nerve Stimulation as Adjunctive Treatment for Drug-Resistant Epilepsy

A phase II trial suggests modest efficacy. Are the findings sufficient to justify a phase III study?

This phase II, double-blind clinical trial was designed to test the safety and efficacy of external trigeminal nerve stimulation (eTMS) in drug-resistant epilepsy (DRE), following encouraging results from a pilot feasibility study (Neurology 2009; 72:936). Researchers randomized 50 patients with DRE to treatment or active control. Bipolar transcutaneous stimulation of ophthalmic nerve branches was applied for at least 12 hours a day (stimulation frequency, 120 Hz; pulse duration <250 µs for active treatment, 2 Hz and 50 µs for control stimulation). Primary outcomes — change in seizure frequency and responder rate (number of subjects with ≥50% seizure frequency reduction) — were measured against a 6-week baseline at 6, 12, and 18 weeks of tr…

Reviewing Author

Robert C. Knowlton, MD, MSPH

Disclosures

Consultant/Advisory BoardMore Health, Inc.; The Alliance of Medical Companies

Grant/Research SupportNIH Small Business Innovation Research

Leadership Positions in Professional SocietiesSouthern Epilepsy & EEG Society (Treasurer)

Robert C. Knowlton, MD, MSPH

Disclosures

Consultant/Advisory BoardMore Health, Inc.; The Alliance of Medical Companies

Grant/Research SupportNIH Small Business Innovation Research

Leadership Positions in Professional SocietiesSouthern Epilepsy & EEG Society (Treasurer)