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RNS System RESPONSE Study

NCT04839601 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-05-22

No results posted yet for this study

Summary

To demonstrate that the RNS System is safe and effective as an adjunctive therapy in individuals age 12 through 17 years with medically refractory partial onset epilepsy.

Conditions

  • Epilepsy
  • Partial Seizure
  • Neurostimulator; Complications
  • Drug Resistant Epilepsy
  • Focal Epilepsy

Interventions

DEVICE

RNS System

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.

Sponsors & Collaborators

  • NeuroPace

    lead INDUSTRY

Principal Investigators

  • Martha Morrell, MD · NeuroPace, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-27
Primary Completion
2025-05-01
Completion
2025-05-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04839601 on ClinicalTrials.gov