Neurostimulation with RNS System for Epilepsy
(RESPONSE Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byMartha Morrell, MD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: NeuroPace
Must be taking: Anti-seizure medications
Must not be taking: Chronic anticoagulants
Disqualifiers: Generalized seizures, Active psychosis, Major depression, Suicidal ideation, others
Stay on Your Current Meds
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, since the trial is for those who have not responded to at least two anti-seizure medications, you may be able to continue your current treatment. Please consult with the trial team for specific guidance.
What data supports the effectiveness of the RNS System treatment for epilepsy?
The RNS System treatment for epilepsy has shown to reduce seizures by 44% in the first year, with improvements to 60-66% in years 3 to 6, without negatively affecting cognition or mood.
12345Is the NeuroPace RNS System safe for humans?
The NeuroPace RNS System is considered a safe alternative for patients with epilepsy who do not respond to medication, as it provides on-demand electrical stimulation to reduce seizures without causing neurological harm.
12346How does the RNS System treatment for epilepsy differ from other treatments?
The RNS System is unique because it is a brain-responsive neurostimulation device that detects abnormal brain activity and delivers electrical stimulation to prevent seizures, unlike traditional treatments that rely on medication or surgery. It provides continuous monitoring and personalized intervention, offering a non-destructive alternative for patients who do not respond to medication and are not candidates for surgery.
12467Eligibility Criteria
This trial is for young individuals aged 12-17 with medically refractory partial onset epilepsy. They must have regular, countable seizures and not be pregnant or using certain medications. Participants need to commit to clinic visits, maintain a seizure diary, and have failed at least two anti-seizure drugs.Inclusion Criteria
Subject and/or parent/guardian must be willing and able to provide informed consent and assent when appropriate.
You have had medical tests that showed you have no more than two areas in your brain that can cause seizures.
I or my caregiver can reliably count and describe my distinct seizures.
+9 more
Exclusion Criteria
Subject is pregnant.
You have a device in your brain that sends electrical energy.
I have been diagnosed with severe mental health issues like psychosis or major depression in the last year.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Implantation and Initial Monitoring
Participants undergo implantation of the RNS System and initial monitoring for device-related adverse events
12 weeks
Regular visits for monitoring
Treatment
Participants receive responsive stimulation with the RNS System
12 months
Monthly visits for device adjustment and monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
Quarterly visits for ongoing assessment
Participant Groups
The RNS System RESPONSE Study is testing the safety and effectiveness of the RNS System as an additional treatment for epilepsy in adolescents. The study involves surgical implantation of this neurostimulator device.
1Treatment groups
Experimental Treatment
Group I: Evaluation Group (stimulation ON)Experimental Treatment1 Intervention
Group of participants that have an RNS System implanted and are being treated with responsive stimulation.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Westchester Medical CenterHawthorne, NY
Spectrum Health SystemGrand Rapids, MI
Spectrum HealthGrand Rapids, MI
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Who Is Running the Clinical Trial?
NeuroPaceLead Sponsor
References
Responsive neurostimulation: Review of clinical trials and insights into focal epilepsy. [2019]The responsive neurostimulator (RNS ®, NeuroPace Inc.) has been available clinically since 2013 for the treatment of medically refractory partial epilepsy. Using intracranial electrodes and a cranially implanted device, RNS ® provides on-demand electrical cortical stimulation to reduce seizures. A randomized, multicenter, double-blind clinical trial demonstrated seizure reduction compared with sham stimulation. Seizure reduction was improved and sustained over years in a long-term treatment trial. The RNS ® provides chronic ambulatory electrographic monitoring over years giving unprecedented insight into epilepsy dynamics. Studies to date have looked at the length of time to detecting bilateral seizure onsets in mesial temporal lobe epilepsy (MTLE), demonstrated biorhythms in interictal epileptiform activity over varied time scales, and shown promise in early detection of benefits of adding a new antiepileptic drug. Questions remain as to the boundaries of patient selection and lead placement. "This article is part of the Supplement issue Neurostimulation for Epilepsy."
The RNS System: brain-responsive neurostimulation for the treatment of epilepsy. [2021]Introduction: Epilepsy affects more than 1% of the US population, and over 30% of adults with epilepsy do not respond to antiseizure medications without life-impacting medication-related side effects. Resection of the seizure focus is not an option for many patients because it would cause unacceptable neurological or cognitive harm. For these patients, neuromodulation has emerged as a nondestructive, effective, and safe alternative. The NeuroPace® RNS® System, the only brain-responsive neurostimulation device, records neural activity from leads placed at one or two seizure foci. When the neurostimulator detects epileptiform activity, as defined for each patient by his or her physician, brief pulses of electrical stimulation are delivered to normalize the activity.Areas covered: This review describes the RNS System, the results of multi-year clinical trials, and the research discoveries enabled by the chronic ambulatory brain data collected by the RNS System.Expert commentary: Brain-responsive neurostimulation could potentially be used to treat any episodic neurological disorder that's accompanied by a neurophysiological biomarker of severity. Combining advanced machine learning approaches with the chronic ambulatory brain data collected by the RNS System could eventually enable automatic fine-tuning of detection and stimulation for each patient, creating a general-purpose neurotechnological platform for precision medicine.
Early detection rate changes from a brain-responsive neurostimulation system predict efficacy of newly added antiseizure drugs. [2021]Brain-responsive neurostimulation (RNS System, NeuroPace) is used to treat medically refractory focal epilepsy and also provides long-term ambulatory neurophysiologic data. We sought to determine whether these data could predict the clinical response to antiseizure drugs (ASDs).
A Novel Robotic-Assisted Technique to Implant the Responsive Neurostimulation System. [2021]The responsive neurostimulation system (RNS) (NeuroPace Inc, Mountain View, California) was approved as an adjunctive therapy for medically refractory focal epilepsy. RNS detects epileptiform patterns and delivers electrical stimulation to abort seizures.
Responsive Direct Brain Stimulation for Epilepsy. [2022]Closed-loop, responsive focal brain stimulation provides a new treatment option for patients with refractory partial onset seizures who are not good candidates for potentially curative epilepsy surgery. The first responsive brain neurostimulator (RNS® System, NeuroPace), provides stimulation directly to the seizure focus when abnormal electrocorticographic is detected. Seizure reductions of 44% at one year increase to 60 to 66% at years 3 to 6 of treatment. There is no negative impact on cognition and mood. Risks are similar to other implanted medical devices and therapeutic stimulation is not perceived.
Operative Technique and Lessons Learned From Surgical Implantation of the NeuroPace Responsive Neurostimulation® System in 57 Consecutive Patients. [2021]The Responsive Neurostimulation (RNS)® System (NeuroPace, Inc) is an implantable device designed to improve seizure control in patients with medically refractory focal epilepsy. Because it is relatively new, surgical pearls and operative techniques optimized from experience beyond a small case series have yet to be described.
Robot-Assisted Responsive Neurostimulator System Placement in Medically Intractable Epilepsy: Instrumentation and Technique. [2020]The management of medically refractory epilepsy patients who are not surgical candidates has remained challenging. Closed loop-or responsive-neurostimulation (RNS) is now an established therapy for the treatment of epilepsy with specific indications. The RNS® system (NeuroPace Inc, Mountainview, California) has recently been shown to be effective in reducing the seizure frequency of partial onset seizures. The electrode design consists of either intracerebral depth electrodes or subdural strip electrodes, and stereotaxis is typically used to guide placement into the EZ. Details on the operative techniques used to place these electrodes have been lacking.