Trial reportEpilepsia2014
Two-year seizure reduction in adults with medically intractable partial onset epilepsy treated with responsive neurostimulation: final results of the RNS System Pivotal trial.
Trial report in Epilepsia, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 245 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
RNS® System Long-term Treatment (LTT) Clinical Investigation
RNS® System Post-Approval Study in Epilepsy
Who cites it
245 citing papers in PubMed, 4 syntheses or guidelines pooled it, 632 citations in OpenAlex.
- The comparison of DBS and RNS for adult drug-resistant epilepsy: a systematic review and meta-analysis.Frontiers in human neuroscience · 2024Pooled it
- Systematic Review of Cost-Effectiveness Analysis for Surgical and Neurostimulation Treatments for Drug-Resistant Epilepsy in Adults.Neurology · 2023Pooled it
- Predictors of outcomes after surgery for medically intractable insular epilepsy: A systematic review and individual participant data meta-analysis.Epilepsia open · 2023Pooled it
- Deep brain and cortical stimulation for epilepsy.The Cochrane database of systematic reviews · 2017Pooled it
- Trial
- Deep brain stimulation of the thalamus for intractable epilepsy (FRANCE study): A randomized clinical trial.Epilepsia · 2026Trial
- Early assessment of responsive neurostimulation for drug-resistant epilepsy in China: A multicenter, self-controlled study.Chinese medical journal · 2025Trial
- Chronic adaptive deep brain stimulation versus conventional stimulation in Parkinson's disease: a blinded randomized feasibility trial.Nature medicine · 2024Trial
- Infection and Erosion Rates in Trials of a Cranially Implanted Neurostimulator Do Not Increase with Subsequent Neurostimulator Placements.Stereotactic and functional neurosurgery · 2017Trial
- Gamma suppression correlates with thalamic stimulation therapeutic response in intractable epilepsy.Epilepsia · 2026Article
- Article
- Engineering Neuronal Network Connectivity Through Precise and Scalable Electrical Modulation.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Long-term neuropsychiatric outcomes after neuromodulation in epilepsy patients: a systematic review and meta-analysis.Acta neurologica Belgica · 2026Review
- Virtual Responsive Neurostimulation Implantation: From Intracranial Connectivity to Optimized Lead Placement.medRxiv : the preprint server for health sciences · 2026Article
- Postapproval Study for Brain-Responsive Neurostimulation for Drug-Resistant Focal Epilepsy: Three-Year Efficacy and Interim Safety Results.Neurology · 2026Article
- Epilepsy: Molecular Pathogenesis and Emerging Therapies.MedComm · 2026Review
- Responsive neurostimulation in children, adolescents, and young Adults-Longitudinal effectiveness and safety.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026Article
- Materials and System Design for Self-Decision Bioelectronic Systems.Advanced materials (Deerfield Beach, Fla.) · 2026Review
- Objective outcome assessment in epilepsy surgery using ultralong-term subcutaneous EEG: A case report.Epilepsia open · 2026Article
- sEEG-guided responsive neurostimulation to treat neocortical epilepsy: A multicenter retrospective study of the efficacy and safety of depth electrode-mediated neuromodulation.Epilepsia open · 2026Article
185 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
36 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo demonstrate the safety and effectiveness of responsive stimulation at the seizure focus as an adjunctive therapy to reduce the frequency of seizures in adults with medically intractable partial onset seizures arising from one or two seizure foci.
methodsRandomized multicenter double-blinded controlled trial of responsive focal cortical stimulation (RNS System). Subjects with medically intractable partial onset seizures from one or two foci were implanted, and 1 month postimplant were randomized 1:1 to active or sham stimulation. After the fifth postimplant month, all subjects received responsive stimulation in an open label period (OLP) to complete 2 years of postimplant follow-up.
resultsAll 191 subjects were randomized. The percent change in seizures at the end of the blinded period was -37.9% in the active and -17.3% in the sham stimulation group (p = 0.012, Generalized Estimating Equations). The median percent reduction in seizures in the OLP was 44% at 1 year and 53% at 2 years, which represents a progressive and significant improvement with time (p < 0.0001). The serious adverse event rate was not different between subjects receiving active and sham stimulation. Adverse events were consistent with the known risks of an implanted medical device, seizures, and of other epilepsy treatments. There were no adverse effects on neuropsychological function or mood. SIGNIFICANCE: Responsive stimulation to the seizure focus reduced the frequency of partial-onset seizures acutely, showed improving seizure reduction over time, was well tolerated, and was acceptably safe. The RNS System provides an additional treatment option for patients with medically intractable partial-onset seizures.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.