RNS System for Drug-Resistant Focal Epilepsy in Adolescents: A Real-World Study

Part of paid clinical trials in Waltham, Massachusetts.

Sponsor
NeuroPace
Study ID
NCT07823465
Status
Enrolling By Invitation

Conditions

  • Drug-resistant Focal Epilepsy
  • Focal Epilepsy

Eligibility Criteria

Sex
ALL
Age
13 Years - 19 Years
Healthy Volunteers
Not accepted

Interventions

  • NeuroPace RNS System — DEVICE
    The NeuroPace RNS System is an implantable, closed-loop responsive neurostimulation device for drug-resistant focal epilepsy. It continuously monitors electrocorticographic activity through leads placed at one or two seizure foci in the brain and, when it detects the electrical patterns associated with seizure onset, delivers brief, typically imperceptible electrical stimulation directly to that focus to interrupt the seizure before it spreads or produces symptoms.

Study Details

The NeuroPace RNS System is FDA-approved for adults with drug-resistant focal epilepsy but is not yet approved for adolescents. This study uses real-world data to evaluate the RNS System's safety and effectiveness in adolescents aged 12 through 17 who have already received the device in routine clinical practice. Data will come from patient-authorized electronic health records and patient-reported outcomes collected through a central study site, not a traditional trial infrastructure. Up to 100 evaluable patients across the United States sites will be enrolled, with results intended to support expansion of the RNS System's approved indication to include this adolescent population.

Key Dates

First listed
Sep 16, 2026
Start date
Sep 14, 2026
Status verified
Sep 2026
Primary completion
Feb 28, 2027
Completion
May 31, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Cohort
    Adolescents (ages 12 through 17) in the United States with drug-resistant focal epilepsy who have already been implanted with the NeuroPace RNS System (Model 320) in routine clinical practice, with implants occurring from 2018 through December 31, 2024.

Primary Outcome Measure

Rate of Serious Adverse Device Events (SADE) [ Time Frame: Implantation through 84 days post-implant ]

Locations (1)

FacilityCityStateZIPSite coordinators
OM1's Central Site (Virtual Site)WalthamMassachusetts02451-

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By research site
OM1's Central Site (Virtual Site)· Waltham, MA

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