Responsive Neurostimulation for Generalized Epilepsy (NAUTILUS Trial)

Recruiting in Palo Alto (17 mi)

+23 other locations

Overseen ByMartha Morrell, MD

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: NeuroPace

Stay on your current meds

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?To demonstrate that the RNS System for thalamic stimulation is safe and effective as an adjunctive therapy for the reduction of primary generalized seizures in individuals 12 years of age or older who have drug-resistant idiopathic generalized epilepsy.

Eligibility Criteria

This trial is for individuals aged 12 or older with drug-resistant idiopathic generalized epilepsy who haven't had a neurostimulator implanted. They must have experienced at least two tonic-clonic seizures recently, be on stable seizure medication, and able to attend clinic visits. Women of childbearing age should use reliable contraception.

Inclusion Criteria

I have had 2 or more severe seizures in the last 2 months.

I am 12 years old or older.

I have been diagnosed with a type of epilepsy that causes different seizure types.

I have tried at least two seizure medications without success.

I've had a CT or MRI in the last 10 years that showed no progressive epilepsy causes.

Exclusion Criteria

I have had a severe seizure without a clear cause in the last year.

I was diagnosed with non-epileptic seizures in the last year.

I am currently taking blood thinners.

I have had partial-onset seizures or related EEG findings in the last 2 years.

Participant Groups

The RNS System NAUTILUS Study tests the safety and effectiveness of responsive thalamic stimulation as an additional treatment for reducing primary generalized seizures compared to sham (fake) stimulation in participants with drug-resistant epilepsy.

2Treatment groups

Active Control

Placebo Group

Group I: Active Group (responsive stimulation ON)Active Control1 Intervention

Participants are implanted with the RNS System and are receiving treatment with responsive stimulation.

Group II: Sham Group (responsive stimulation OFF)Placebo Group1 Intervention

Participants are implanted with the RNS System and are not receiving treatment with responsive stimulation.