Epilepsy is the fourth most common neurological disorder in the United States and affects people of all ages. It’s a spectrum disorder and, as such, the kinds of seizures people suffer and how they are managed will vary from patient to patient. Currently about 3 million people in the US are living with epilepsy and experts predict that at least 1 in 26 people will develop epilepsy at some point in their lifetime.
For some patients, seizures can sometimes be controlled by medication, but in others, the drugs do not work. Patients with the most common form of partial or localized epilepsy have what is called drug-resistant mesial temporal lobe epilepsy (MTLE) and managing the disorder in these patients is especially difficult.
It was announced recently by the U.S. Food and Drug Administration's (FDA) that an Investigational Device Exemption, (IDE), had been granted for a new tool that could be used in certain surgical procedures designed to help control seizure activity. An IDE allows a device that is still in the development process to be approved for human clinical trials, in order to speed up completion and hopefully get a functioning device available to patients quicker. The SLATE ((Stereotactic Laser Ablation for Temporal Lobe Epilepsy) study will test a device called the Visualase MRI-Guided Laser Ablation Technology.
The study will treat approximately 120 adult patients with drug-resistant MTLE at selected epilepsy centers across the United States. After being evaluated to make sure they are candidates for surgery, participants will undergo the Visualase procedure which uses MRI-guided instruments to ablate areas of the brain where the epileptic seizures originate. Patients who have the procedure will be followed up for 12 months post-surgery. The follow-up will include medical assessments to judge the effectiveness of the procedure and whether or not it resulted in a reduction in the number of seizures as well as any adverse events, neuropsychological symptoms and qualify of life issues as well.
Medical professionals who treat patients for epilepsy are hopeful that the new device and improved surgical procedure could result in better outcomes for patients living with seizures that, so far, have been uncontrolled. In a press release from Medtronic, the company developing the system Robert Gross, M.D., Ph.D, MBNA/Bowman professor of neurosurgery and director, Functional, Stereotactic and Epilepsy Surgery Division at Emory University in Atlanta, GA said, "This is a significant step in collecting evidence regarding laser ablation as a treatment option for MTLE. We are eager to begin enrolling patients."
The procedure works by first drilling a small hole in the skull. A thin applicator cable is guided via MRI to the affected area of the brain and the light pulses of laser energy raise the temperature of the soft tissue, essentially killing off the part of the brain that sends out errant electrical signals that cause seizures. After those signals are stopped, other parts of the brain are thought to compensate for the small amount of lost tissue. The video below talks more about how the procedure could help those with uncontrolled seizures; check it out.
SOURCES: UCSF, Medtronic, Epilepsy Foundation