Trial reportStereotactic and functional neurosurgery2017
Infection and Erosion Rates in Trials of a Cranially Implanted Neurostimulator Do Not Increase with Subsequent Neurostimulator Placements.
Trial report in Stereotactic and functional neurosurgery, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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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.
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Who cites it
4 citing papers in PubMed, 32 citations in OpenAlex.
- Simultaneous craniotomy for resection and placement of responsive neurostimulation for treatment of medically refractory epilepsy: illustrative cases.Journal of neurosurgery. Case lessons · 2025Article
- Intracranial electroencephalographic biomarker predicts effective responsive neurostimulation for epilepsy prior to treatment.Epilepsia · 2022Article
- Responsive Neurostimulation as a Novel Palliative Option in Epilepsy Surgery.Neurologia medico-chirurgica · 2021Review
- Nine-year prospective efficacy and safety of brain-responsive neurostimulation for focal epilepsy.Neurology · 2020Article
Corrections and comments
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Authors and funding
6 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND/
aimsThe RNS® System utilizes a cranially implanted neurostimulator attached to leads placed at the seizure focus to provide brain responsive stimulation for the treatment of medically intractable partial onset epilepsy. Infection and erosion rates related to the cranial implant site were assessed overall and by neurostimulator procedure to determine whether rates increased with additional procedures.
methodsInfection and erosion rates were calculated as (1) chance per neurostimulator procedure, (2) incidence per patient implant year, and (3) rates for initial and each subsequent neurostimulator implant (generalized estimating equation).
resultsIn 256 patients followed for an average of 7 years, the infection rate was 3.7% per neurostimulator procedure (n = 31/840), and the rate of erosions was 0.8% per neurostimulator procedure (n = 7/840). Rates did not increase with subsequent neurostimulator procedures (p = 0.66, infection; p = 0.70, erosion). A prior infection or erosion at the implant site did not significantly increase the risk at a later procedure (p ≥ 0.05 for all combinations).
conclusionThese data indicate that the risk for infection compares favorably to other neurostimulation devices and suggest that rates of infection and erosion do not increase with subsequent neurostimulator replacements.
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Registered trials
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