Background: The Medtronic “Percept” is the first FDA-approved deep brain stimulation (DBS) device with sensing capabilities during active stimulation. Its real-world signal-recording properties have yet to be fully described. Objective: This study details three sources of artifact (and potential mitigations) in local field potential (LFP) signals collected by the Percept and assesses the potential impact of artifact on the future development of adaptive DBS (aDBS) using this device. Methods: LFP signals were collected from 7 subjects in both experimental and clinical settings. The presence of artifacts and their effect on the spectral content of neural signals were evaluated in both the stimulation ON and OFF states using three distinct offline artifact removal techniques. Results: Template subtraction successfully removed multiple sources of artifact, including (1) electrocardiogram (ECG), (2) nonphysiologic polyphasic artifacts, and (3) ramping-related artifacts seen when changing stimulation amplitudes. ECG removal from stimulation ON (at 0 mA) signals resulted in spectral shapes similar to OFF stimulation spectra (averaged difference in normalized power in theta, alpha, and beta bands ≤3.5%). ECG removal using singular value decomposition was similarly successful, though required subjective researcher input. QRS interpolation produced similar recovery of beta-band signal but resulted in residual low-frequency artifact. Conclusions: Artifacts present when stimulation is enabled notably affected the spectral properties of sensed signals using the Percept. Multiple discrete artifacts could be successfully removed offline using an automated template subtraction method. The presence of unrejected artifact likely influences online power estimates, with the potential to affect aDBS algorithm performance.
1. Deep brain stimulation is a widely used therapy for Parkinson’s disease (PD) but currently lacks dynamic responsiveness to changing clinical and neural states. Feedback control has the potential to improve therapeutic effectiveness, but optimal control strategy and additional benefits of “adaptive” neurostimulation are unclear. We implemented adaptive subthalamic nucleus stimulation, controlled by subthalamic or cortical signals, in three PD patients (five hemispheres) during normal daily life. We identified neurophysiological biomarkers of residual motor fluctuations using data-driven analyses of field potentials over a wide frequency range and varying stimulation amplitudes. Narrowband gamma oscillations (65-70 Hz) at either site emerged as the best control signal for sensing during stimulation. A blinded, randomized trial demonstrated improved motor symptoms and quality of life compared to clinically optimized standard stimulation. Our approach highlights the promise of personalized adaptive neurostimulation based on data-driven selection of control signals and may be applied to other neurological disorders.
Background: Hyperkinetic movement disorders involve excessive, involuntary movements such as ataxia, chorea, dystonia, myoclonus, tics, and tremor. Recent advances in artificial intelligence (AI) allow investigators to integrate multimodal instrumented movement measurements and imaging techniques and to analyze these data together at scale. In this systematic review, we aim to characterize AI’s performance in diagnosing and quantitatively phenotyping these disorders. Methods: We searched PubMed and Embase using a semi-automated article-screening pipeline. Results: Fifty-five studies met the inclusion criteria (n = 11,946 subjects). Thirty-five studies used machine learning, sixteen used deep learning, and four used both. Thirty-eight studies reported disease diagnosis, twenty-three reported quantitative phenotyping, and six reported both. Diagnostic accuracy was reported in 36 of 38 and correlation coefficients in 10 of 23 studies. Kinematics (e.g., accelerometers and inertial measurement units) were the most used dataset. Diagnostic accuracy was reported in 36 studies and ranged from 56 to 100% compared to clinical diagnoses to differentiate them from healthy controls. The correlation coefficient was reported in 10 studies and ranged from 0.54 to 0.99 compared to clinical ratings for quantitative phenotyping. Five studies had an overall judgment of “low risk of bias” and three had external validation. Conclusion: There is a need to adopt AI-based research guidelines to minimize reporting heterogeneity and bolster clinical interpretability.
We recorded over 500 h of neural activity in a patient with cervical dystonia using a sensing-enabled DBS device—the most extensive dataset to date. Multisite recordings were paired with wearable and kinematic analysis of 100+ home videos. Low-frequency and narrowband gamma oscillations correlated with tremor and were suppressed by DBS, which also induced entrained gamma oscillations. These neural changes tracked with clinical and kinematic improvements, suggesting potential biomarkers of DBS effectiveness.
One-third of the world’s 70 million people with epilepsy have seizures that are not controlled by medication; and implantable devices are an exciting option for treatment. These devices improve seizure control and can detect impending attacks, missed medication, and impaired cognition. Unfortunately, they have no way to share this information with their hosts in real-time – a limitation common to most medical devices. This is a missed opportunity for implants and wearables to learn from patients, focus on what matters most to them, and teach them how their behavior affects their health. Here, we present a device platform that converses with patients and learns to co-manage epilepsy. The inpatient pro-totype links scalp and intracranial EEG (electroencephalograms) to secure large language models that communicate freely and bidirectionally with their hosts through a smartphone app. An AI agent ingests biomarkers of sleep, medication level, cognition, and seizure risk extracted from brain activity. It con-verses with patients to inform them of clinical events and physiological trends, records their symptoms, responses, and behaviors, and automatically retrains itself to improve performance. Both patients and the AI agent can initiate conversations to teach each other and personalize interactions. We demon-strate this platform in 13 patients undergoing inpatient video-EEG monitoring for epilepsy and validate its performance. Algorithms for detecting seizures optimized their precision over several days without expert intervention – in contrast to the months of iterative, in-person physician programming currently required. Patients responded positively to messages regarding sleep, cognition, and seizure risk while rating the system as highly usable. The platform includes several safeguards, including a system for further algorithm fine-tuning using efficient expert review, and features that ensure data security and regulate communication content. Further work will link other biosensors to measure behavior, improve performance, and optimize therapeutic stimulation. We propose this system as a scalable platform for medical devices that can rapidly adapt to patient and provider needs; one that is broadly adaptable to improving care for many medical conditions.
Background The Medtronic “Percept” is the first FDA approved deep brain stimulation (DBS) device with sensing capabilities during active stimulation. Its real-world signal recording properties have yet to be fully described. Objective This study details sources of artifact (and potential mitigations) in local field potential (LFP) signals collected by the Percept, and assesses the potential impact of artifact on the future development of adaptive DBS (aDBS) using this device. Methods LFP signals were collected from seven subjects in both experimental and clinical settings. The presence of artifacts and their effect on the spectral content of neural signals were evaluated in both the stimulation ON and OFF states using three distinct offline artifact removal techniques. Results Template subtraction successfully removed multiple sources of artifact, including 1) electrocardiogram (ECG), 2) non-physiologic polyphasic artifacts, and 3) ramping related artifacts seen when changing stimulation amplitudes. ECG removal from stimulation ON (at 0 mA) signals recovered the spectral shape seen when OFF stimulation (averaged difference in normalized power in theta, alpha, and beta bands ≤ 3.5%). ECG removal using singular value decomposition was similarly successful, though required subjective researcher input. QRS interpolation produced similar recovery of beta-band signal, but resulted in residual low-frequency artifact. Conclusions Artifacts present when stimulation is enabled notably affected the spectral properties of sensed signals using the Percept. Multiple discrete artifacts could be successfully removed offline using an automated template subtraction method. The presence of unrejected artifact likely influences online power estimates, with the potential to affect aDBS algorithm performance.