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An implanted device for brain-responsive neurostimulation (RNS System) isapproved as an effective treatment to reduce seizures in adults withmedically-refractory focal epilepsy. Clinical trials of the RNS Systemdemonstrate population-level reduction in average seizure frequency, buttherapeutic response is highly variable. Recent evidence links seizures tocyclical fluctuations in underlying risk. We tested the hypothesis thateffectiveness of responsive neurostimulation varies based on current statewithin cyclical risk fluctuations. We analyzed retrospective data from 25adults with medically-refractory focal epilepsy implanted with the RNS System.Chronic electrocorticography was used to record electrographic seizures, andhidden Markov models decoded seizures into fluctuations in underlying risk.State-dependent associations of RNS System stimulation parameters with changesin risk were estimated. Higher charge density was associated with improvedoutcomes, both for remaining in a low seizure risk state and for transitioningfrom a high to a low seizure risk state. The effect of stimulation frequencydepended on initial seizure risk state: when starting in a low risk state,higher stimulation frequencies were associated with remaining in a low riskstate, but when starting in a high risk state, lower stimulation frequencieswere associated with transition to a low risk state. Findings were consistentacross bipolar and monopolar stimulation configurations. The impact of RNS onseizure frequency exhibits state-dependence, such that stimulation parameterswhich are effective in one seizure risk state may not be effective in another.These findings represent conceptual advances in understanding the therapeuticmechanism of RNS, and directly inform current practices of RNS tuning and thedevelopment of next-generation neurostimulation systems.

Evidence of state-dependence in the effectiveness of responsive neurostimulation for seizure modulation