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
RNS System clinical study for teens 12 through 17 years of age with focal onset epilepsy
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. Physician and Patient Manuals
applicable for this study are provided at the links that follow the investigational Indications for Use.
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.
Eligibility
Key Inclusion Criteria
- 12 years of age or older with drug-resistant idiopathic generalized epilepsy.
- Confirmed diagnosis of idiopathic generalized epilepsy with generalized tonic-clonic
seizures, with or without myoclonic or absence seizures. - 2 or more generalized tonic-clonic seizures during the combined 2 month retrospective
and 1 month prospective baseline. - Failed treatment with a minimum of two antiseizure medications.
- On stable antiseizure medications during 2 month retrospective baseline and willing to
remain on stable antiseizure medications during prospective Baseline and throughout
Blinded period. - Had routine EEG prior to enrollment with features consistent with IGE.
- No VNS, or VNS is OFF during the two month retrospective baseline and willing to keep
the VNS off during the study.
Key Exclusion Criteria
- Requires procedures contraindicated1 based on current RNS System labeling.
- Participant has a history of partial-onset seizures or EEG findings indicative of
partial-onset or symptomatic generalized abnormalities. - Diagnosed with active psychosis2, major depression or suicidal ideation in
preceding year. - Diagnosed with psychogenic or non-epileptic seizures in preceding year.
- Experienced unprovoked status epilepticus in preceding year.
1For contraindications refer to current manuals at www.neuropace.com
2Does not include post-ictal psychiatric symptoms
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. Physician and Patient Manuals
applicable for this study are provided at the links that follow the investigational Indications for Use.
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.
Eligibility
Key Inclusion Criteria
- Participant has medically intractable epilepsy defined as failure to achieve acceptable
seizure control without unacceptable medication related side effects despite trials of 2
or more antiseizure medications. - Participant had an average of ≥ 5 drop seizures per month in the 2 months preceding
enrollment. A drop seizure is defined as an epileptic seizure (atonic, tonic,
tonic-clonic, or myoclonic) involving the entire body, trunk, or head that leads or
could lead to a fall, injury, or slumping in a chair. - Participant’s scalp recorded EEG has features of LGS, such as multifocal spike, slow
spike and wave discharges, and paroxysmal fast activity. - Participant must (a) have a stable antiseizure medication (ASM) regimen for the 2 months
preceding enrollment and (b) be willing to remain on the stable regimen, as medically
able, through the Blinded Evaluation Period; rescue medication for acute seizure
clusters are permitted. A stable ASM regimen is defined as no introduction or
discontinuation of an ASM, and no change in an ASM dose of more than 25%. - Participant is not on a therapeutic diet for epilepsy, or if participant is on a
therapeutic diet for epilepsy must (a) have a stable diet for the 2 months preceding
enrollment and (b) be willing to remain on the stable diet, as medically able, through
the Blinded Evaluation Period. - Participant does not have a vagus nerve stimulator (VNS), or if participant does have a
VNS must (a) have had the VNS off for the 2 months preceding enrollment and (b) be
willing to remain with the VNS off through the end of the study.
Key Exclusion Criteria
- Participant is currently implanted with an electronic medical device that delivers
electrical energy to the brain. - Participant is currently implanted with an RNS Neurostimulator or NeuroPace Leads.
- Participant requires procedures that are contraindicated based on current RNS System
labeling. - Participant has a diagnosed unstable psychiatric disorder or any attempt or expressed
intent of suicide over the preceding 6 months. - In the opinion of the investigator, the participant has a clinically significant or
unstable medical condition [including alcohol, opioid, recreational cannabis (not for
therapeutic purposes) or other drug use disorder] or a progressive central nervous
system disease.
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)
Encuentre Un Centro
ClinicalTrials.gov:
NCT05339126
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. En los enlaces siguientes a las indicaciones de uso para la fase de investigación, se proporcionan los manuales para los médicos y para los pacientes correspondientes a este estudio. 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.
Manuales para los médicos
Manuales para los pacientes
Elegibilidad
Principales criterios de inclusión
- El participante tiene epilepsia resistente al tratamiento farmacológico que se define como la imposibilidad de lograr un control aceptable de las crisis epilépticas sin efectos secundarios inaceptables relacionados con los fármacos a pesar de haber probado 2 o más medicamentos antiepilépticos.
- El participante tiene un promedio de ≥5 crisis epilépticas con episodio de caída por mes en los 2 meses anteriores a la inscripción. Una crisis epiléptica con episodio de caída se define como una crisis epiléptica (atónica, tónica, tónico-clónica o mioclónica) que involucra todo el cuerpo, el tronco o la cabeza y que podría provocar que la persona sufra una caída, una lesión o se desplome en una silla.
- El EEG registrado desde el cuero cabelludo del participante tiene características del SLG, como puntas multifocales, descargas de punta y onda lenta y actividad paroxística rápida.
- El participante debe (a) tener un tratamiento estable con medicamentos antiepilépticos MAE) durante los 2 meses previos a la inscripción y (b) estar dispuesto a continuar con ese tratamiento estable, en la medida en que sea capaz desde el punto de vista médico, durante el período de evaluación con enmascaramiento. Se permiten los medicamentos de rescate para las series de crisis epilépticas agudas. Un tratamiento estable con MAE se define como la no introducción y la no discontinuación de un MAE, así como que no haya cambios de más del 25 % en la dosis de MAE.
- El participante no realiza una dieta terapéutica para la epilepsia o, en el caso de que realice una dieta terapéutica para la epilepsia, el paciente debe (a) llevar una dieta estable durante los 2 meses previos a la inscripción y (b) estar dispuesto a continuar con la dieta estable, en la medida en que sea capaz desde el punto de vista médico, durante el período de evaluación con enmascaramiento.
- El participante no tiene un estimulador del nervio vago (ENV) o, en el caso de que tenga un ENV, el participante debe (a) haber tenido el ENV apagado durante los 2 meses previos a la inscripción y (b) estar dispuesto a continuar con el ENV apagado hasta el final del estudio.
Principales criterios de exclusión
- El participante tiene actualmente implantado un dispositivo médico electrónico que administra energía eléctrica al cerebro.
- El participante tiene actualmente implantado un neuroestimuador RNS o cables conductores NeuroPace.
- El participante debe someterse a procedimientos que están contraindicados en función de las indicaciones actualmente autorizadas del sistema RNS.
- El participante tiene diagnóstico de un trastorno psiquiátrico inestable o ha intentado o expresado suicidarse en los últimos 6 meses.
- Según la opinión del investigador, el participante tiene una afección inestable o clínicamente significativa (incluido el trastorno por consumo de alcohol, opioides, cannabis con fines recreativos —no terapéuticos— u otras drogas) o una enfermedad progresiva del sistema nervioso central.
RNS System Responsive Stimulation for Adolescents with Epilepsy (RESPONSE) Study
Age
12 through 17
Gender
All
Epilepsy Type
Medically Refractory, Partial Onset Seizures
Find a Center
ClinicalTrials.gov:
NCT04839601
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. Physician and Patient Manuals applicable for this study are provided at the links that follow the investigational Indications for Use. 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).
Eligibility
Key Inclusion Criteria
- Disabling motor simple partial, complex partial and/or secondarily generalized seizures.
- Average of 3 or more disabling seizures over 2 most recent consecutive 30-day periods, with no period <2 seizures.
- Failed treatment with minimum of 2 anti-seizure medications.
- Undergone diagnostic testing as part of standard of care that identified no more than 2 epileptogenic regions.
- 12 through 17 years of age at time of implant.
- Not currently implanted with RNS Neurostimulator or RNS NeuroPace Leads.
Key Exclusion Criteria
- Primary generalized seizures.
- In investigator’s opinion, subject has clinically significant or unstable medical condition or progressive central nervous system disease.
- Diagnosed with active psychosis, major depression or suicidal ideation in preceding year.
- Diagnosed with psychogenic or non-epileptic seizures.
- Experienced unprovoked status epilepticus in preceding year.
- Requires procedures that are contraindicated based on current RNS System labeling.
- Is taking chronic anticoagulants.
For medical and scientific questions about the RNS® System, please contact: medicalaffairs@neuropace.com
