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Responsive Neurostimulation for Generalized Epilepsy (NAUTILUS Trial)

Phase 3

Waitlist Available

Led By Martha Morrell, MD

Research Sponsored by NeuroPace

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant has had 2 or more generalized tonic-clonic seizures during the two month retrospective baseline

Participant is age 12 and older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up implant through 2 years post-implant

Awards & highlights

NAUTILUS Trial Summary

This trial shows that the RNS System for thalamic stimulation is safe and effective for reducing primary generalized seizures in individuals 12 years of age or older with drug-resistant idiopathic generalized epilepsy.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While not specified here, side effects may include discomfort or complications from the implant surgery, possible infection risk, device-related issues like malfunction or migration, and potential neurological effects such as changes in mood or memory.

NAUTILUS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 12 years old or older.

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

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I have tried at least two seizure medications without success.

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

NAUTILUS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ implant through 2 years post-implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~implant through 2 years post-implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and implant through 2 years post-implant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

12-week post-operative serious device-related adverse event (SADE) rate

Time to second generalized tonic-clonic (GTC) seizure

Secondary outcome measures

Amenorrhea

Other outcome measures

Affective status as assessed by the Beck Depression Inventory

Annual event rate of Serious Adverse Device Effects (SADEs)

Annual event rate of Serious Adverse Events (SAEs) of particular relevance

+5 more

NAUTILUS Trial Design

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

NeuroPaceLead Sponsor

10 Previous Clinical Trials

1,399 Total Patients Enrolled

Martha Morrell, MDPrincipal InvestigatorNeuroPace, Inc.

2 Previous Clinical Trials

224 Total Patients Enrolled

Media Library

Active Group (responsive stimulation ON) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05147571 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we enrolling patients for this research project currently?

"Yes, this is an ongoing study that is presently seeking patients. The listing on clinicaltrials.gov says the trial was first posted on 8/9/2022 and last updated on 11/9//2022."

Answered by AI

Has the FDA accepted Active Group's application for use?

"Active Group (responsive stimulation ON) has received a score of 3 for safety. This is based off of it being a Phase 3 trial, which suggests that not only is there some data supporting efficacy, but multiple rounds of data also support safety."

Answered by AI

In how many different geographical areas is this research project being run right now?

"9 sites are available for this study, they are: Nicklaus Children's Hospital in Miami, Mt. Sinai in New york, Spectrum Health Butterworth Hospital in Grand Rapids and 6 others."

Answered by AI