EpilepsyNAUTILUSNCT05147571
RNS System NAUTILUS Study
A study testing Responsive stimulation in people with Epilepsy and Idiopathic Generalized Epilepsy, run by NeuroPace at 23 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Epilepsy, Idiopathic Generalized Epilepsy, Generalized Tonic Clonic Seizure
- What is being tested?
- Responsive stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 23 sitesUnited States
- Study dates
- 9 Aug 2022to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant is age 12 and older.
- Participant is male or is a female of childbearing potential who is surgically sterile, 2 years postmenopausal, or practices a reliable method of contraception (hormonal, barrier method or abstention).
- Participant failed treatment with a minimum of two antiseizure medications (used in appropriate doses) with adequate monitoring of compliance and the effects of treatment, as determined by the investigator.
- Participant is able to maintain an electronic diary alone or with the assistance of a competent individual.
- Participant is able to attend clinic appointments in accordance with the study schedule.
- Participant or parent(s) or legal representative have signed an IRB approved written informed consent/assent. The informed consent form or specific assent form, where required, will be signed and dated by minors.
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- Participant is not currently implanted with an RNS Neurostimulator or NeuroPace Leads.
- In the investigator's opinion, participant is able to tolerate a neurosurgical procedure.
- Participant with a confirmed diagnosis of idiopathic generalized epilepsy experiencing primary generalized tonic-clonic seizures, with or without myoclonic or absence seizures, consistent with the International League against Epilepsy Revised Classification of Seizures (2017).
- Participant has had 2 or more generalized tonic-clonic seizures during the two month retrospective baseline.
- Participant has had a routine electroencephalogram (EEG) within 2 years prior to enrollment with electroencephalographic features consistent with idiopathic generalized epilepsy; other concomitant anomalies must be explained by adequate past medical history.
- Participant has been on a stable antiseizure medication (ASM) regimen during the two month retrospective baseline and is willing to remain on a stable ASM regimen during the prospective Baseline and throughout the Effectiveness Evaluation Period, if medically possible; rescue benzodiazepine medications for acute seizure clusters are permitted.
- Participant has undergone computed tomography (CT) or magnetic resonance imaging (MRI) within 10 years prior to enrollment that ruled out a progressive cause of epilepsy or an abnormality likely to be associated with focal-onset seizures.
- Participant does not have a vagus nerve stimulator (VNS, LivaNova) or Participant's VNS is OFF during the two month retrospective baseline and participant is willing to keep the VNS off during the study.
Who cannot join
- Participant is pregnant.
- Participant is participating in a therapeutic investigational drug or other device study.
- Participant is implanted with an electronic medical device that delivers electrical energy to the brain.
- Participant requires procedures that are contraindicated based on current RNS System labeling.
- Participant has been diagnosed with active psychosis, major depression or suicidal ideation in the preceding year. Participants with post-ictal psychiatric symptoms need not be excluded.
- In the opinion of the investigator, the participant has a clinically significant or unstable medical condition (including alcohol and/or drug abuse) or a progressive central nervous system disease.
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- Participant has a history of partial-onset seizures or EEG findings within the past 2 years indicative of partial-onset or symptomatic generalized abnormalities.
- Participant has been diagnosed with psychogenic or non-epileptic seizures in the preceding year.
- Participant has experienced unprovoked status epilepticus in the preceding year.
- Participant is taking any anticoagulants.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
University of New Mexico
Albuquerque, New Mexico, 87131
University of Colorado
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Spectrum Health Butterworth Hospital
Grand Rapids, Michigan, 48503
Baylor College of Medicine
Houston, Texas, 77030
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Indiana University Health
Indianapolis, Indiana, 46202
University of Kansas Medical Center
Kansas City, Kansas, 66160
Mary Hitchcock Memorial Hospital (Dartmouth)
Lebanon, New Hampshire, 03756
University of Louisville
Louisville, Kentucky, 40202
Nicklaus Children's Hospital
Miami, Florida, 33155
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
New York University Langone
New York, New York, 10016
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Mayo Clinic - Arizona
Phoenix, Arizona, 85054
UPMC
Pittsburgh, Pennsylvania, 15213
Oregon Health and Science University
Portland, Oregon, 97239
Mayo Clinic - Rochester
Rochester, Minnesota, 55902
University of Utah Healthcare
Salt Lake City, Utah, 84132
Washington University
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33606
About this study
Official title: RNS® System Responsive Thalamic Stimulation for Primary Generalized Seizures (NAUTILUS) Study
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.
Read the detailed description
NeuroPace is sponsoring the NAUTILUS Study with the RNS System for thalamic stimulation as an adjunctive therapy for the treatment of generalized seizures in individuals 12 years of age or older who have drug-resistant idiopathic generalized epilepsy. The RNS System is currently approved by the FDA for use in patients 18 years and older with hard-to-treat partial-onset seizures. The same device will be used in the NAUTILUS Study.
The study is a prospective, multicenter, single-blind, randomized, sham stimulation controlled pivotal study and participants will be followed for two years after placement of the RNS System. The study will enroll a maximum of 100 participants within the United States to ensure that at least 80 participants are implanted with the RNS System.
The study design includes a two-month retrospective and one-month prospective baseline. All participants will have detection enabled at the time of implant. At one month post-implant, participants will be randomized 1:1 to Active or Sham stimulation. For those randomized to the Active group, stimulation will be enabled. Participants will be blinded to their own randomization status until the 2nd GTC occurs for that individual, they completed the 9-month Effectiveness Evaluation Period (12-months post-implant), or the 60th GTC-event occurs in the group, whichever occurs first. After that, patients will be unblinded and patients in the Sham group (responsive stimulation OFF) will have responsive stimulation enabled (responsive stimulation ON).
- Being tested
- Responsive stimulation, Sham stimulation
- Keywords
- Medically refractory, Responsive neurostimulation, RNS System, Thalamic stimulation
- Medical subject headings
- Epilepsy, Epilepsy, Idiopathic Generalized, Epilepsy, Tonic-Clonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Responsive stimulationDevice
The RNS System provides closed loop responsive brain stimulation. The Neurostimulator monitors the electrical activity of the brain to detect abnormal activity that could lead to a seizure. If abnormal activity is detected, the neurostimulator delivers electrical stimulation to the brain through the leads to help prevent the seizure before it occurs.
Sham stimulationDevice
For those in the Sham Stimulation group, the RNS System will be set to detect abnormal activity but will not have responsive stimulation enabled. Both Sham and Active groups will undergo therapy testing at each appointment in order to maintain the blind.
| Study group | Role | What they receive |
|---|---|---|
| Active Group (responsive stimulation ON) | Active comparator | Participants are implanted with the RNS System and are receiving treatment with responsive stimulation. Receives: Device: Responsive stimulation |
| Sham Group (responsive stimulation OFF) | Sham comparator | Participants are implanted with the RNS System and are not receiving treatment with responsive stimulation. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-week post-operative serious device-related adverse event (SADE) rate
The primary safety endpoint is the percent of participants with serious device-related adverse events (SADE) at 84 days (12 weeks) post-implant.
Measured: 84 days post-implant (12 weeks)
Time to second generalized tonic-clonic (GTC) seizure
The primary effectiveness endpoint is the time to a participant's 2nd GTC seizure (also defined as a GTC-event) during the 9-month Effectiveness Evaluation Period. Across participants, once the 60th GTC-event occurs, the study will have collected the necessary data to assess the primary effectiveness endpoint; all participants will then be unblinded.
Measured: 9-month Effectiveness Evaluation Period
Secondary outcomes (1)
Percent change in monthly rate of days with any type of generalized seizure (generalized tonic-clonic, myoclonic, absence)
The secondary effectiveness endpoint will be the percent change in the monthly rate of days with any type of generalized seizure (generalized tonic-clonic, myoclonic or absence) during the 9-month Effectiveness Evaluation Period compared to baseline.
Measured: 9-month Effectiveness Evaluation Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start9 Aug 2022
- Primary completion4 Apr 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroPace
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martha Morrell, MD, Principal investigator, NeuroPace, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147571
- Sponsor's protocol ID
- NP10016
- Acronym
- NAUTILUS
- Status last verified
- Jun 2026
- First submitted
- 23 Nov 2021
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RNS® System Responsive Thalamic Stimulation for Primary Generalized Seizures (NAUTILUS) Study
- ClinicalTrials.gov ID
- NCT05147571
- Acronym / sponsor ID
- NAUTILUS / NP10016
- Keywords
- Medically refractory, Responsive neurostimulation, RNS System, Thalamic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- NeuroPaceIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
NeuroPace is sponsoring the NAUTILUS Study with the RNS System for thalamic stimulation as an adjunctive therapy for the treatment of generalized seizures in individuals 12 years of age or older who have drug-resistant idiopathic generalized epilepsy. The RNS System is currently approved by the FDA for use in patients 18 years and older with hard-to-treat partial-onset seizures. The same device will be used in the NAUTILUS Study.
The study is a prospective, multicenter, single-blind, randomized, sham stimulation controlled pivotal study and participants will be followed for two years after placement of the RNS System. The study will enroll a maximum of 100 participants within the United States to ensure that at least 80 participants are implanted with the RNS System.
The study design includes a two-month retrospective and one-month prospective baseline. All participants will have detection enabled at the time of implant. At one month post-implant, participants will be randomized 1:1 to Active or Sham stimulation. For those randomized to the Active group, stimulation will be enabled. Participants will be blinded to their own randomization status until the 2nd GTC occurs for that individual, they completed the 9-month Effectiveness Evaluation Period (12-months post-implant), or the 60th GTC-event occurs in the group, whichever occurs first. After that, patients will be unblinded and patients in the Sham group (responsive stimulation OFF) will have responsive stimulation enabled (responsive stimulation ON).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Group (responsive stimulation ON) | Active comparator | Device: Responsive stimulationParticipants are implanted with the RNS System and are receiving treatment with responsive stimulation. |
| Sham Group (responsive stimulation OFF) | Sham comparator | Device: Sham stimulationParticipants are implanted with the RNS System and are not receiving treatment with responsive stimulation. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Participant is age 12 and older.
- Participant is male or is a female of childbearing potential who is surgically sterile, 2 years postmenopausal, or practices a reliable method of contraception (hormonal, barrier method or abstention).
- Participant failed treatment with a minimum of two antiseizure medications (used in appropriate doses) with adequate monitoring of compliance and the effects of treatment, as determined by the investigator.
- Participant is able to maintain an electronic diary alone or with the assistance of a competent individual.
- Participant is able to attend clinic appointments in accordance with the study schedule.
Key exclusion criteria (10 listed)
- Participant is pregnant.
- Participant is participating in a therapeutic investigational drug or other device study.
- Participant is implanted with an electronic medical device that delivers electrical energy to the brain.
- Participant requires procedures that are contraindicated based on current RNS System labeling.
- Participant has been diagnosed with active psychosis, major depression or suicidal ideation in the preceding year. Participants with post-ictal psychiatric symptoms need not be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Responsive stimulationThe RNS System provides closed loop responsive brain stimulation. The Neurostimulator monitors the electrical activity of the brain to detect abnormal activity that could lead to a seizure. If abnormal activity is detected, the neurostimulator delivers electrical stimulation to the brain through the leads to help prevent the seizure before it occurs. | Device | Active Group (responsive stimulation ON) |
| Sham stimulationFor those in the Sham Stimulation group, the RNS System will be set to detect abnormal activity but will not have responsive stimulation enabled. Both Sham and Active groups will undergo therapy testing at each appointment in order to maintain the blind. | Device | Sham Group (responsive stimulation OFF) |
Primary outcome
12-week post-operative serious device-related adverse event (SADE) rate
Time frame: 84 days post-implant (12 weeks)
The primary safety endpoint is the percent of participants with serious device-related adverse events (SADE) at 84 days (12 weeks) post-implant.
Time to second generalized tonic-clonic (GTC) seizure
Time frame: 9-month Effectiveness Evaluation Period
The primary effectiveness endpoint is the time to a participant's 2nd GTC seizure (also defined as a GTC-event) during the 9-month Effectiveness Evaluation Period. Across participants, once the 60th GTC-event occurs, the study will have collected the necessary data to assess the primary effectiveness endpoint; all participants will then be unblinded.
1 secondary outcome
Percent change in monthly rate of days with any type of generalized seizure (generalized tonic-clonic, myoclonic, absence)
Time frame: 9-month Effectiveness Evaluation Period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Morrell, MD principal investigator
NeuroPace, Inc.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Responsive stimulation in people with Epilepsy and Idiopathic Generalized Epilepsy, run by NeuroPace at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-week post-operative serious device-related adverse event (SADE) rate (time frame: 84 days post-implant (12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.