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(HealthNewsDigest.com) – Epilepsy patients who have not responded to treatment with commonly used drugs may benefit from a new therapy that delivers high frequency bursts of stimulation, or microbursts, in patients who have drug-resistant epilepsy.
Microburst vagus nerve stimulation functions like a heart pacemaker. The device is surgically placed under the skin and attached to the vagus nerve, which sends regular pulses to the brain to prevent seizures from occurring. The stimulator’s settings can be changed according to each patient’s needs using a special programming wand, with no additional surgery needed.
Dr. Rebecca O’Dwyer, assistant professor of neurology, at the Rush University Medical Center in Chicago, Illinois, enrolled the first patient in the clinical study on February 28. The study examines the use of a new Microburst Vagus Nerve Stimulation Therapy System on drug-resistant epilepsy. The study will evaluate the initial safety and effectiveness of delivering high frequency bursts of stimulation, or microbursts, in patients who have drug-resistant epilepsy.
“At the Rush Epilepsy Center, we regularly collaborate with members of the neurosurgery and neuroradiology department in our research endeavors. We look forward to the results of this study and hope we can bring relief to more people with epilepsy,” said O’Dwyer.
Rush was the first in Chicago to offer epilepsy patients the original vagal nerve stimulator — which prevents seizures by sending mild pulses of electrical energy to the brain by way of the vagus nerve. Vagus nerve stimulation therapy was approved by the U.S. Food and Drug Administration in 1997 as an adjunctive treatment for drug-resistant epilepsy. The system consists of two implantable components: a programmable electronic pulse generator that is connected to a bipolar electrical lead, which sends mild pulses to stimulate the vagus nerve at regular intervals throughout the day.
“While vagus nerve stimulation at gradual intervals can be used for drug-resistant epilepsy, we are now exploring how higher frequency bursts delivered to the vagus nerve will affect epilepsy that does not respond to traditional therapies,” said O’Dwyer.
The pre-market feasibility study consists of two groups of patients with epilepsy, enrolling up to 40 patients in total at approximately 15 sites in the United States. The first group will include 20 patients with primary generalized tonic-clonic seizures. The second group will consist of 20 patients with partial onset seizures, including complex partial seizures with or without secondary generalization.
Each patient will participate in the study for a minimum of 15 months. Primary endpoints will measure the percent change in seizure frequency and occurrence of stimulation-related adverse events in comparison to a patient’s baseline. Activation of various areas of the brain in response to stimulation will be assessed using functional magnetic resonance imaging or fMRI. Secondary endpoints will be evaluated to assess changes from baseline in seizure severity, quality of life, antiepileptic drug use, suicidality and adverse events.
The VNS Therapy system was created by LivaNova PLC, a medical technology company.