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Analyzing Neural Activity and Connectivity Using Intracranial EEG Data with SPM Software
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Simulating Clinical Trials With and Without Intracranial EEG Data.

Daniel M Goldenholz1, Joseph J Tharayil1,2, Rubin Kuzniecky3

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Utilizing intracranial EEG (icEEG) confirmed seizures in clinical trials significantly enhances statistical power compared to relying solely on patient-reported events. This improved accuracy can accelerate drug discovery and reduce trial costs.

Keywords:
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Area of Science:

  • Neurology
  • Clinical Trials
  • Biostatistics

Background:

  • Clinical trials for neurological disorders often rely on patient-reported seizure data.
  • The utility of electrographic seizure data, particularly from chronically implanted intracranial EEG (icEEG), in improving trial efficiency is not well understood.

Purpose of the Study:

  • To determine if incorporating knowledge of clinically silent (electrographic) seizures improves the statistical efficiency of clinical trials.
  • To compare the statistical power of clinical trial outcomes based on different seizure data collection methods.

Main Methods:

  • A Monte Carlo bootstrapping simulation study was conducted using data from 10 patients with chronically implanted subdural electrodes over an average of 1 year.
  • Simulated trials assessed statistical power using patient-reported seizures with icEEG confirmation, all patient-reported events, or all icEEG-confirmed seizures.
  • Drug efficacy was simulated at 10%, 20%, 30%, 40%, and 50%, with outcomes measured by responder rates (RR50) and median percentage change (MPC).

Main Results:

  • The median percentage change (MPC) method consistently demonstrated higher statistical power than the 50%-responder rate (RR50) method across simulated drug strengths.
  • Statistical power increased proportionally with simulated drug efficacy.
  • Using all available icEEG-confirmed seizures yielded significantly higher statistical power (p<0.001) compared to using patient-reported events, regardless of icEEG confirmation.

Conclusions:

  • Simulation results indicate that enhanced seizure detection accuracy through chronically implanted icEEG significantly improves the statistical power of clinical trials.
  • Advanced seizure detection devices, both invasive and noninvasive, hold potential for increasing statistical efficiency, expediting drug discovery, and reducing clinical trial expenses.