RNS System NAUTILUS Study
← catalyst calendarSponsored by NeuroPace (industry) · NPCE — their whole pipeline →.
Phase
Not applicable
Status
Completed
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
100actual
Sites
23
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-08-09 | actual | When the study began enrolling |
| Primary completion | 2025-04-04 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-03-31 | actual | The whole study's end, after follow-up |
| First posted | 2021-12-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-08 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Epilepsy
- Idiopathic Generalized Epilepsy
- Generalized Tonic Clonic Seizure
Interventions
- Device: Responsive stimulation
- Device: Sham stimulation
Primary outcomes
what the primary-completion date above is the date OF12-week post-operative serious device-related adverse event (SADE) rate
measured 84 days post-implant (12 weeks)
Time to second generalized tonic-clonic (GTC) seizure
measured 9-month Effectiveness Evaluation Period
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