RNS System LGS Feasibility Study
← catalyst calendarSponsored by NeuroPace (industry) · NPCE — their whole pipeline →. With National Institute of Neurological Disorders and Stroke (NINDS), University of Florida.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
24estimated
Sites
6
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 | 2022-10-04 | actual | When the study began enrolling |
| Primary completion | 2026-05-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2022-04-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Epilepsy
- Lennox Gastaut Syndrome
- Lennox-Gastaut Syndrome, Intractable
- Seizures
- Seizures, Generalized
Intervention
- Device: RNS System
Primary outcomes
what the primary-completion date above is the date OFSafety: Annual device-related serious adverse event (SADE) rate
measured 12 months post-implant
Safety: Annual device-related serious adverse event (SADE) rate
measured 24 months post-implant
Effectiveness: Blinded evaluation period (BEP) responder rate
measured 12 months post-implant
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