NeuroPace is committed to continuing to improve the lives of people living with epilepsy.
See below for information on NeuroPace sponsored FDA-approved IDE clinical trials currently open to enrollment.
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
RNS System clinical study for teens 12 through 17 years of age with focal onset epilepsy
CLOSED TO ENROLLMENT
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
ClinicalTrials.gov:
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)
ClinicalTrials.gov:
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.
Estudio de estimulación de respuesta del sistema RNS para adolescentes y
adultos con el síndrome de Lennox-Gastaut (SLG)
Edad
A partir de los 12 años
Género
Todos
Tipo De Epilepsia
Epilepsia generalizada primaria resistente al tratamiento farmacológico, crisis epilépticas generalizadas primarias (síndrome de Lennox-Gastaut)
ClinicalTrials.gov:
Propósito del estudio
El propósito del estudio sobre el sistema RNS para el tratamiento del síndrome de Lennox-Gastaut (SGL) es generar datos preliminares sobre la seguridad y la eficacia de la neuroestimulación de respuesta cerebral de las redes talamocorticales como tratamiento complementario para reducir la frecuencia de las crisis epilépticas generalizadas en personas de 12 años o más con SLG resistente a los medicamentos antiepilépticos.
Indicaciones de uso y documentación técnica del producto para el estudio
El sistema RNS está en fase de investigación con respecto a las indicaciones de uso que se mencionan a continuación. El neuroestimulador RNS, modelo RNS-320, se usará en el estudio del síndrome de Lennox-Gastaut.
Los médicos deben remitirse al protocolo de investigación para conocer más información sobre el producto específica para el estudio.
Los pacientes deben comunicarse con el médico del estudio para obtener más información específica relacionada con la participación en el estudio.
AVISO: Dispositivo en fase de investigación. Limitado por las leyes de los Estados Unidos al uso en investigación para las siguientes indicaciones de uso:
El uso previsto en fase de investigación del sistema RNS® es como tratamiento complementario para reducir la frecuencia de las crisis epilépticas generalizadas en personas de 12 años o más con síndrome de Lennox-Gastaut que no responden al tratamiento con medicamentos antiepilépticos.
RNS System Responsive Stimulation for Adolescents with Epilepsy (RESPONSE) Study
Age
12 through 17
Gender
All
Epilepsy Type
Medically Refractory, Partial Onset Seizures
ClinicalTrials.gov:
Study Intent
The primary intent of this pivotal study is to determine whether the RNS System is safe and effective as an adjunctive therapy in individuals ages 12 through 17 years who have drug-resistant focal 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 RESPONSE study.
Clinicians should refer to the investigational protocol for additional product information specific to the study.
CAUTION—Investigational device. Limited by United States law to investigational use for the following Indications for Use:
The RNS System investigational intended use is as an adjunctive therapy in reducing the frequency of seizures in individuals 12 through 17 years of age with partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures (motor partial seizures, complex partial seizures and/or secondarily generalized seizures).
For medical and scientific questions about the RNS® System, please contact: medicalaffairs@neuropace.com
