Trial reportNeurology2015
Long-term treatment with responsive brain stimulation in adults with refractory partial seizures.
Trial report in Neurology, 2015. 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 246 papers, 6 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
246 citing papers in PubMed, 6 syntheses or guidelines pooled it, 626 citations in OpenAlex.
- Neurostimulation in children with drug-resistant epilepsy: strategies in subcortical targeting and systematic review of the evidence.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2025Pooled it
- Responsive neurostimulation in pediatric epilepsy: a systematic review and individual patient meta-analysis supplemented by a single institution case series in 105 aggregated patients.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2024Pooled it
- Automated algorithms for seizure forecast: a systematic review and meta-analysis.Journal of neurology · 2024Pooled it
- A Systematic Review of Interventions for Health Anxiety Presentations Across Diverse Chronic Illnesses.International journal of behavioral medicine · 2019Pooled it
- Multiple Subpial Transections for Medically Refractory Epilepsy: A Disaggregated Review of Patient-Level Data.Neurosurgery · 2018Pooled it
- Deep brain and cortical stimulation for epilepsy.The Cochrane database of systematic reviews · 2017Pooled it
- Trial
- Early assessment of responsive neurostimulation for drug-resistant epilepsy in China: A multicenter, self-controlled study.Chinese medical journal · 2025Trial
- Multisensory flicker modulates widespread brain networks and reduces interictal epileptiform discharges.Nature communications · 2024Trial
- Trial
- Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Drug-Resistant Epilepsy in the MORE Multicenter Patient Registry.Neurology · 2023Trial
- Network reorganization of anterograde thalamic connectivity during non-periodic patterned deep brain stimulation.iScience · 2026Article
- Stereo-electroencephalography-guided responsive neuromodulation: A propensity-matched cohort study.Epilepsia · 2026Article
- Long-term neuropsychiatric outcomes after neuromodulation in epilepsy patients: a systematic review and meta-analysis.Acta neurologica Belgica · 2026Review
- The seizure embedding map: a spatio-temporal transformer for comparing patients by ictal intracranial EEG features at scale.Journal of neural engineering · 2026Article
- Single pulse electrical stimulation in white matter modulates iEEG visual responses in human early visual cortex.PLoS computational biology · 2026Article
- 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
- Robotic Surgery in Pediatric Epilepsy : Current Evidence, Clinical Impact, and Future Directions.Journal of Korean Neurosurgical Society · 2026Article
- Epilepsy: Molecular Pathogenesis and Emerging Therapies.MedComm · 2026Review
186 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
40 authors at 20 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe long-term efficacy and safety of responsive direct neurostimulation was assessed in adults with medically refractory partial onset seizures.
methodsAll participants were treated with a cranially implanted responsive neurostimulator that delivers stimulation to 1 or 2 seizure foci via chronically implanted electrodes when specific electrocorticographic patterns are detected (RNS System). Participants had completed a 2-year primarily open-label safety study (n = 65) or a 2-year randomized blinded controlled safety and efficacy study (n = 191); 230 participants transitioned into an ongoing 7-year study to assess safety and efficacy.
resultsThe average participant was 34 (±11.4) years old with epilepsy for 19.6 (±11.4) years. The median preimplant frequency of disabling partial or generalized tonic-clonic seizures was 10.2 seizures a month. The median percent seizure reduction in the randomized blinded controlled trial was 44% at 1 year and 53% at 2 years (p < 0.0001, generalized estimating equation) and ranged from 48% to 66% over postimplant years 3 through 6 in the long-term study. Improvements in quality of life were maintained (p < 0.05). The most common serious device-related adverse events over the mean 5.4 years of follow-up were implant site infection (9.0%) involving soft tissue and neurostimulator explantation (4.7%).
conclusionsThe RNS System is the first direct brain responsive neurostimulator. Acute and sustained efficacy and safety were demonstrated in adults with medically refractory partial onset seizures arising from 1 or 2 foci over a mean follow-up of 5.4 years. This experience supports the RNS System as a treatment option for refractory partial seizures. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that for adults with medically refractory partial onset seizures, responsive direct cortical stimulation reduces seizures and improves quality of life over a mean follow-up of 5.4 years.
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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.