NeuroPace received FDA nod for IDE trial on closed-loop neuromodulation therapy for idiopathic generalized epilepsy (IGE)

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NeuroPace has received an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) allowing is to proceed with the “NAUTILUS study”—which will assess the company’s RNS electrical stimulation system in patients with drug-resistant idiopathic generalized epilepsy (IGE). This IDE approval follows NeuroPace receiving FDA Breakthrough Device designation status in March 2021.

The Neuropace RNS system is a non-drug closed-loop neuromodulation system that both monitors and responds to changing brain state, applying electrical stimulation only when it is likely to have a benefit which is typically before clinical symptoms occur. The central challenge with neuromodulation for epilepsy (in its treatment in general) is blocking the abnormal epileptic brain activity while sparing normal brain function. But optimization stimulation for only those moment where “undesirable” activity occurs, the RNS closed-loop system aims to be more specific.

Idiopathic generalized epilepsy (IGE) an epilepsy disorder understood to have a strong underlying genetic basis. Patients with an IGE are typically otherwise normal and have no structural brain abnormalities. People with IGE often have a family history of epilepsy making it seem there is a genetic predisposition.

The “NAUTILUS” Phase 3 clinical study will be the first (in the USA) to evaluate the use of NeuroPace’s RNS technology for the treatment of IGE. It is a prospective, single-blinded, multicenter randomized trial design with enrollment starting in 2022.

In 2014, NeuroPace received US FDA premarket approval for RNS for the treatment for adults with partial onset seizures that have not been controlled with two or more antiepileptic drugs. If the trial is successful, this would expand the indications for the Neuropace RNS system is indicted.

In addition to Neuropace, Medtronic currently offer a closed-loop Deep Brain Stimulation system, for investigational use only. The RNS system is invasive and required implantation. Non-invasive neuromodulation approach are also being investigated including focused ultrasound (FUS), Transcranial Magnetic Stimulation (TMS), and transcranial Direct Current Stimulation (tDCS). Because non-invasive technologies cannot be on (worn) all the time, they generally rely in inducing lasting (plastic) changes in the brain. Invasive systems like RNS are always present (since they are implanted) and can work only by acute “responsive” stimulation.

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