NeuroPace is committed to continuing to improve the lives of people living with epilepsy.
RNS System clinical study for adults and teens 12 years and older with idiopathic generalized epilepsy
CLOSED TO ENROLLMENT
RNS System clinical study for adults and teens 12 years and older with Lennox‑Gastaut Syndrome
CLOSED TO ENROLLMENT
Researchers are studying how the RNS System has worked in teenagers with focal epilepsy. This is a records-only study, participation is by invitation, and NeuroPace Nurse Navigators contact eligible patients directly.
RNS System Pivotal Study of Responsive Bilateral Thalamic Stimulation for Idiopathic Generalized Seizures (NAUTILUS) Study
Age
12 or older
Gender
All
Epilepsy Type
Medically Refractory Idiopathic Generalized Epilepsy, Primary generalized seizures
Find a Center
ClinicalTrials.gov:
NCT05147571
Study Intent
The primary intent of the NAUTILUS Pivotal Study is to determine if the RNS System is safe and effective
as an additional therapy in individuals 12 years and older who have drug-resistant idiopathic
generalized epilepsy.
Study Indication for Use & Product Labeling
The RNS System is investigational for the Indications for Use below. The RNS Neurostimulator Model RNS-320 will be used in the NAUTILUS Study.
Clinicians should refer to the investigational protocol for additional product information specific to
the study.
Patients should contact their study physician for additional information specific to participation in
this study.
CAUTION–Investigational device. Limited by United States law to investigational use for the
following Indications for Use:
The RNS® System is intended for thalamic stimulation as an adjunctive therapy for the treatment of
primary generalized seizures in individuals 12 years of age or older who have drug-resistant
idiopathic generalized epilepsy.
RNS System Responsive Stimulation for Teens and Adults with Lennox-Gastaut Syndrome (LGS) Study
Age
12 and older
Gender
All
Epilepsy Type
Medically Refractory Primary Generalized Epilepsy, Primary generalized seizures (Lennox-Gastaut
Syndrome)
Find a Center
ClinicalTrials.gov:
NCT05339126
Study Intent
The purpose of the RNS System Lennox-Gastaut Syndrome (LGS) study is to generate preliminary safety and effectiveness data for brain-responsive neurostimulation of thalamocortical networks as an adjunctive therapy in reducing the frequency of generalized seizures in individuals 12 years of age or older with LGS who are refractory to antiseizure medications.
Study Indication for Use & Product Labeling
The RNS System is investigational for the Indications for Use below. The RNS Neurostimulator Model RNS-320 will be used in the Lennox-Gastaut Syndrome Study.
Clinicians should refer to the investigational protocol for additional product information specific to
the study.
Patients should contact their study physician for additional information specific to participation in
this study.
CAUTION–Investigational device. Limited by United States law to investigational use for the following Indications for Use:
The RNS® System is intended as an adjunctive therapy in reducing the frequency of generalized seizures in individuals 12 years of age or older with Lennox-Gastaut Syndrome who are refractory to antiseizure medications.
The AURORA Study: Understanding Responsive Neurostimulation in Young People with Epilepsy
ADOLESCENT PARTICIPANTS · RETROSPECTIVE · RECORDS + QUESTIONNAIRE
Age
12–17 years old at the time of implant
Gender
All
Epilepsy Type
Focal
ClinicalTrials.gov:
Researchers are studying how the RNS System has worked in teenagers with focal epilepsy, seizures that begin in one specific area of the brain.The RNS System is a small, implanted device that continuously monitors brain activity. When it detects unusual electrical patterns that may lead to a seizure, it delivers a gentle pulse to interrupt that activity. Participants have this device, or have had it, during their clinical care.Because this is a retrospective study, researchers look only at health information already collected as part of normal medical care. Participants will also be asked to complete a short questionnaire about seizure history.By allowing access to health records and completing the questionnaire, participants help researchers understand how well RNS therapy works in teenagers, knowledge that could improve epilepsy treatment for future generations of young patients.
| 100participants in study | 12–17 years oldat the time of implant | $40Visa gift card |
What Participation Involves
Participation has two components:
- Give permission to access medical records
- Complete the questionnaire, a short survey about seizure types and history, completed at the participant’s convenience in approximately 10–15 minutes.
What we will NOT do
- Contact participants beyond the questionnaire
- Request any new tests or evaluations
- Alter current treatment in any way
- Access unrelated medical records
- Share identifiable information publicly
- Use data for commercial purposes
Compensation
As a thank-you, participants will receive a $40 Visa gift card upon completion of the questionnaire. There is no other cost or financial obligation associated with participation. The gift card is provided regardless of answers given and does not depend on any particular outcome.
Privacy & Data Protection
Protecting participant privacy is a top priority. All data handling complies with HIPAA and is overseen by an Institutional Review Board (IRB).
- De-identification: names and identifying details are removed before data is analyzed or shared with the research team.
- Limited access: only authorized researchers with a specific need may access study data. All access is logged and monitored.
- Aggregate reporting: publications present findings as group statistics only. Individual participant data will never be identifiable.
- IRB oversight: this study has been reviewed and approved by an ethics board to ensure it meets all standards for health records research.
Results may be published in medical journals or presented at scientific conferences. All published findings use only group-level, de-identified data. No participant’s name will ever appear in any publication.
For medical and scientific questions about the RNS® System, please contact: medicalaffairs@neuropace.com
