First patient treated in study of neuromodulation device for Lennox-Gastaut Syndrome

NeuroPace Inc. announced that the first patient with Lennox-Gastaut Syndrome was treated in its investigational device exemption feasibility study, which will evaluate the company’s neuromodulation technology.

According to a release from NeuroPace, the ongoing study utilizes the RNS System, which has demonstrated safety and effectiveness of brain-responsive stimulation for treating medically intractable focal onset seizures in adults, and will assess whether brain-responsive neurostimulation can also be used to treat Lennox-Gastaut Syndrome (LGS).

The first procedure took place at Emory Healthcare in Atlanta and was performed by Robert E. Gross, MD, PhD, the MBNA Bowman Chair in Neurosurgery and professor and vice chair of the Emory University department of neurosurgery, the company stated.

According to the release, NeuroPace received a $9.3 million NIH grant through the Brain Research through Advancing Innovative Neurotechnologies (BRAIN Initiative), which will fund evaluation of the technology. The study is expected to be conducted at six sites and enroll 20 patients aged 12 years and older with LGS and drug-resistant generalized onset seizures.

“In addition to finding the best detection and stimulation settings for responsive neurostimulation in LGS, we are looking to identify changes in the recorded brain data that indicate whether the therapy is effective,” Martha Morrell, MD, chief medical officer at NeuroPace, said in the release. “These so-called biomarkers may help clinicians treat LGS and also facilitate future research, including the possibility of a larger clinical study into the mechanisms of the disease and treatment approaches.”

At present, antiseizure medications are the standard-of-care treatment for LGS, the company said, adding that seizures are rarely controlled — even with multiple medications — and it is typical for patients with LGS to experience increasing disability over their lifetime.

“Overall, treatment is rarely effective in LGS, and the outcome remains very poor,” Tracy Dixon-Salazar, PhD, executive director of the LGS Foundation, said in the release. “Those living with LGS need new treatment options for the many seizures, LGS-associated disorders and treatment side-effects our loved ones suffer.”