The randomised, multicentre, prospective, controlled pivotal study has been designed to evaluate the RNS System’s effectiveness and safety as an adjunctive therapy for the treatment of IGE, also called primary generalised epilepsy.
It will be conducted in participants aged 12 years and above with hard-to-treat IGE.
The study will specifically include IGE patients whose seizures are not controlled by antiseizure medications and experience primary generalised seizures, including generalised tonic clonic seizures with or without myoclonic or absence seizures.
The procedure was performed at Vanderbilt Health in Nashville, Tennessee, US, with co-investigators Dario Englot and Angela Crudele.
NeuroPace chief medical officer Martha Morrell said: “This is a groundbreaking study that could allow individuals who have drug-resistant generalised epilepsy to be treated with the RNS System.
“Brain-responsive neuromodulation is a proven therapy for drug-resistant focal epilepsy, with long-term studies demonstrating significant seizure reduction and quality of life improvements for patients.
“I look forward to investigating whether this therapy could provide similar benefits to patients suffering from primary generalised epilepsy, helping to fill a large unmet need in this population.”
The RNS System has been designed to provide personalised, data-driven treatment that targets the seizure source.
It works by continuously monitoring brain activity and is programmed to recognise the unique seizure pattern of a patient, automatically responding with imperceptible stimulation to prevent seizures before they start.
The system records and reports ongoing electroencephalogram (EEG) data that helps physicians to personalise patient care.
Last year, NeuroPace received US Food and Drugs Administration (FDA) Breakthrough Device Designation status for its RNS System to treat IGE.
It is claimed to be the only brain-responsive neuromodulation system that has been approved by the FDA.