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A Rational Approach to Understanding and Evaluating Responsive Neurostimulation.

Nathaniel D Sisterson1, Thomas A Wozny2, Vasileios Kokkinos3,4

  • 1Department of Neurological Surgery, Brain Modulation Lab, University of Pittsburgh, Pittsburgh, PA, USA. nds38@pitt.edu.

Neuroinformatics
|January 11, 2020
PubMed
Summary

Daily device behavior in closed-loop epilepsy therapy is poorly understood. Analyzing RNS device logs alongside ECoG data reveals significant discrepancies in seizure detection accuracy, necessitating a combined approach for reliable performance assessment.

Keywords:
Closed-loopDevice configurationDrug-resistant epilepsyExtrapolationNeuromodulationSeizure detection

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Area of Science:

  • Neurology
  • Biomedical Engineering
  • Epilepsy Research

Background:

  • Closed-loop brain stimulation, particularly the RNS device, is vital in epilepsy management.
  • Daily operational insights into these devices are lacking, hindering therapy optimization and patient outcomes.
  • Understanding device performance is crucial for improving seizure reduction in epilepsy patients.

Purpose of the Study:

  • To quantify the accuracy of seizure detection and stimulation by the RNS device.
  • To compare device logging data with manually reviewed electrocorticography (ECoG) recordings.
  • To develop and evaluate a methodology for adjusting device log data for bias and incompleteness.

Main Methods:

  • Analysis of RNS System event logging data from twelve patients over a mean of 21.5 months.
  • Development of a weighted-means methodology to adjust for biases in event logs.
  • Evaluation using Bland-Altman plots and Wilcoxon signed-rank tests to compare adjusted and standard methods.

Main Results:

  • Mean seizure frequency reduction was 40.1% post-RNS implantation.
  • Significant differences (p < 10^-6) in accuracy, sensitivity, and specificity were found between extrapolated and standard results.
  • Event logging completeness varied: ECoG recordings (3.0%), Event Lists (72.9%), and Activity Logs (100%).

Conclusions:

  • RNS device performance metrics derived solely from event logs are unreliable.
  • Manual review of ECoG data is essential for accurate assessment of closed-loop system performance.
  • Combining device logs with ECoG review provides a more accurate extrapolation of detector and stimulation performance.