High sensitivity movement disorder treatment device or system

Inventors

Giuffrida, Joseph P. • Heldman, Dustin A.

Assignees

Great Lakes Neurotechnologies Inc

Abstract

The present invention relates to a movement disorder monitor with high sensitivity, and a method of measuring the severity of a subject's movement disorder. The present invention additionally relates to a drug delivery system for dosing a subject in response to the increased severity of a subject's symptoms. The present invention provides for a system and method, which can accurately and repeatably quantify symptoms of movements disorders, accurately quantifies symptoms utilizing both kinetic information and/or electromyography (EMG) data, that can be worn continuously to provide continuous information to be analyzed as needed by the clinician, that can provide analysis in real-time, that allows for home monitoring of symptoms in subject's with these movement disorders to capture the complex fluctuation patterns of the disease over the course of days, weeks or months, that maximizes subject safety, and that provides substantially real-time remote access to data by the clinician or physician.

Core Innovation

The disclosed invention provides a movement disorder device or system for treating a subject's movement disorder through deep brain stimulation based on a calculated severity of symptoms of the subject's movement disorder. A diagnostic component includes a sensor unit component and a processor, where the sensor unit component includes at least one sensor having a signal associated with external body motion. The processor receives the signal and calculates a quantified severity of the subject's symptoms of movement disorder in real time.

The system further includes a treatment delivery component that comprises at least one electronic component or actuator adapted for adjusting a device for deep brain stimulation treatment, where an electrical output of the deep brain stimulation is adjusted based in part on the calculated quantified severity in real time. The diagnostic component is required to have a real-time average intraclass correlation (ICC) of at least about 0.60 for the quantified severity of the subject's particular symptoms of movement disorder. The disclosed embodiments also allow symptom severity calculation to be based at least in part on an electromyogram (EMG) sensor measuring electrical muscle activity.

The disclosed invention also provides a movement disorder device or system that treats a subject's movement disorder with a pharmaceutical based on a calculated severity of symptoms of the subject's movement disorder. In this configuration, the diagnostic component receives a signal associated with external body motion and calculates a quantified severity of the subject's symptoms of movement disorder in real time, and the treatment delivery component adjusts the pharmaceutical based in part on the calculated quantified severity in real time. In addition, the diagnostic component is required to have a real-time average intraclass correlation (ICC) of at least about 0.60, and symptom severity may be calculated based at least in part on measured electrical muscle activity from an EMG sensor.

Claims Coverage

The independent claims cover a movement-disorder monitoring and treatment system that calculates a real-time quantified severity of symptoms from external body motion sensing, and adjusts either deep brain stimulation output and/or a pharmaceutical based on that quantified severity in real time. Across the independent claims, the diagnostic component includes a sensor unit and processor, and imposes quality constraints using real-time average intraclass correlation (ICC) or real-time average minimum detectable change (MDC), with optional EMG-based severity calculation in dependent claims.

Overall, the independent claims require a sensor-based diagnostic component that calculates a quantified severity in real time from signals associated with external body motion, treatment delivery components that adjust either deep brain stimulation electrical output and/or pharmaceutical based on that calculated severity in real time, and diagnostic reliability/performance constraints using either real-time average intraclass correlation (ICC) of at least about 0.60 or real-time average minimum detectable change (MDC) representing about 25% or less of a total scale on a rating scale when calibrated or adjusted.

Stated Advantages

Documented Applications