Medical device dev Neuroelectrics today released results from an FDA investigational device exemption trial of its Starstim device intended to treat patients with drug resistant epilepsy, touting a significant reduction in seizure frequency.
The Starstim device from the Cambridge, Mass.-based company provides transcranial current stimulation, delivering mild electrical currents to the specific areas of the patient’s brain where seizures originate. The system is intended to be worn for 20 minutes per day, and is non-invasive, the company said.
“We are pleased that this clinical study has demonstrated the safety and efficacy of Starstim in treating epilepsy. We are proud of having conducted the first FDA-sanctioned clinical trial in transcranial current stimulation in any indication, positioning Neuroelectrics as the leader in developing an option for patients that employs this powerful therapeutic brain stimulation technology,” CEO Ana Maiques said in a prepared statement.
The study was performed at Boston Children’s Hospital, with adult patients referred from Beth Israel Deaconess Medical Center. A parallel study was also conducted at the National Institute of Neurology and Neurosurgery in Mexico City, the company said. Patients selected for the trial had not responded to at least two anti-epileptic medications, Neuroelectrics said.
Results from the trial indicated that treatment with the Starstim device resulted in a 40% reduction in seizure frequency in 75% of the patient population, measured out to eight weeks post-treatment. No device-related adverse events were reported during the study.
“We and our patients are delighted to have a non-invasive and non-pharmacologic option for those whose seizures have not been controlled by drugs or by surgery. Our patients and families have seen clear improvements in well-being and quality of life,” co-principal investigator Dr. Alexander Rotenberg said in a press release.