Deep Brain Stimulation Guided by Brain Mapping to Treat Cognitive Impairment

Brief Summary

This trial is a 12-month safety and feasibility study, enrolling up to six participants. These participants will serve as their own controls, structured in multiple parts that follow an initial short-term stereo electroencephalography (SEEG) mapping period. During this trial we aim to demonstrate the safety of acute and chronic network-guided stimulation in Mild Cognitive Impairment by evaluating adverse effects, tolerability, and feasibility during both the short- term SEEG mapping phase and subsequent permanent DBS therapy. In addition to safety measures, therapeutic results as follows are to be tested for: (1) Develop patient-specific stimulation parameters for the treatment of MCI, as well as develop and test memory state classifiers by enrolling six individuals to undergo intracranial mapping (SEEG). We will use targeted memory tasks to generate neural data needed for state distinctions, and conduct a systematic parameter search to identify and develop optimal settings for each patient. (2) Assess efficacy of open loop stimulation by delivering a fixed open loop protocol based on the parameters discovered earlier, while SEEG electrodes remain in place, and testing the efficacy of the trained classifier to detect favorable brain states. (3) Evaluate chronic DBS therapy by implanting a permanent system in participants who show an acute beneficial response to assess long term outcomes. (4) Assess therapeutic outcomes and refine protocols by measuring reductions in memory-related impairment. The above findings will guide further refinement of the device and protocol.