Device and method for monitoring and assessment of movement disorder symptoms
Inventors
Heldman, Dustin A. • Giuffrida, Joseph P. • Mera, Thomas O.
Assignees
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Publication Number
US-11986317-B1
Publication Date
2024-05-21
Expiration Date
Abstract
The present invention is directed to a device and method for monitoring and assessment of movement disorder symptoms. The device and method disclosed herein are particularly amenable to remote monitoring of a subject's movement disorder symptoms. Briefly stated, in certain preferred embodiments of the present invention the movement disorder monitoring device accompanies a subject to a remote location where the device is used to record data relating to the severity of a subject's movement disorder symptoms over a period of time. This data is then subsequently used by physicians or other clinicians in optimizing and assessing treatment options directed at alleviating a subject's movement disorder symptoms. The method and device of the present invention can be used to monitor symptoms of a number of movement disorders including but not limited to dystonia, essential tremor, Huntington's disease, various ataxias, multiple sclerosis, psychogenic tremor, and Parkinson's disease.
Core Innovation
The invention relates to a portable movement-disorder monitoring device and a remote monitoring method for recording movement data and quantified symptom severity of a subject outside a clinic over time. The monitoring device includes a memory and at least one sensor configured to acquire movement data corresponding to movement disorder symptoms of at least one of the subject’s extremities, and to process and analyze the movement data to quantify severity. A first processor communicates with a database or other remote facility to transmit acquired movement data and/or quantified symptom severity, including as data is collected from the subject in near real-time.
The invention further relates to a therapy device combination that provides and/or adjusts therapy or treatment for movement disorder symptoms. The system includes a drug dose or a drug pump or deep brain stimulation (DBS) device comprising therapy or treatment parameters, where the drug pump or DBS device provides therapy or treatment based on therapy or treatment parameters. The database or at least one second processor, or an algorithm based on the database, receives the movement data and/or quantified symptom severity and analyzes them to determine a quantified efficacy of the drug dose or drug pump or DBS therapy or treatment parameters at alleviating the subject’s movement disorder symptoms, and determines whether the drug dose or drug pump or DBS therapy or treatment parameters should be changed.
The invention generates a system output comprising new drug dose and/or new therapy or treatment parameters for the drug pump or DBS device based at least in part on the results of the analysis. A remote interface provides clinician or physician access to the movement data, quantified symptom severity, quantified efficacy, and/or system output and allows the new drug dose or new therapy or treatment parameters to be entered into the drug pump or DBS device. The system also produces time-indexed report data for viewing and/or analysis, with an ordered measure of how data and/or symptoms change over time, and can include subject journal or diary entry data via a subject interface that enables subject-controlled input.
Claims Coverage
The partial set contains three independent claims (clm-00001, clm-00008, and clm-00015). Across these independent claims, the coverage centers on a therapy device combination that integrates movement data acquisition and severity quantification, remote analysis of quantified efficacy, therapy parameter change determination, and clinician access to updated therapy output, with near-real-time transmission and time-indexed report display in some forms.
Therapy device combination with quantified efficacy analysis and therapy adjustment
A system comprising a drug dose adapted to be provided or a drug pump or DBS device adapted to provide drug dose or DBS therapy based on therapy or treatment parameters; a movement disorder monitoring device with memory and at least one sensor for acquiring movement data corresponding to movement disorder symptoms of at least one subject extremity, wired or wireless communication with at least one first processor to process and analyze the movement data and quantify severity; a database or other remote facility with at least one second processor or algorithm adapted to receive acquired movement data and/or quantified symptom severity; processors adapted to analyze the movement data and/or quantified symptom severity to determine quantified efficacy of the drug dose or drug pump or DBS therapy or treatment parameters and determine whether therapy parameters should be changed; a system output comprising a new drug dose or new therapy or treatment parameters based at least in part on the analysis; and at least one remote interface adapted for clinician/physician access and allowing entry of the new drug dose or new therapy or treatment parameters into the drug pump or DBS device.
Near-real-time database transmission and time-indexed report generation
A therapy device combination in which the movement disorder monitoring device transmits movement data and quantified symptom severity to a database in near real-time as data is collected; processors generate a report via software and index and display the report data relative to time for viewing and/or analysis by a clinician, physician, and/or the subject, providing an ordered measure of how the data or a subject’s symptoms change over time.
Near-real-time transmission of preprocessed movement data and clinician-controlled therapy output
A therapy device combination where the movement disorder monitoring device is adapted to transmit preprocessed movement data and/or quantified symptom severity to the database in near real-time as data is collected from the subject, combined with analysis to determine quantified efficacy and whether the drug dose or drug pump or DBS therapy or treatment parameters should be changed, and a system output comprising new drug dose or new therapy or treatment parameters entered via a remote interface for clinician/physician access.
Across the independent claims, the core inventive structure is a closed-loop therapy management system: movement data are acquired from subject extremities and used to quantify symptom severity, the database or remote facility determines quantified efficacy and whether therapy parameters should change, and updated drug dose or DBS parameters are provided as system output through a remote interface, with some embodiments emphasizing near real-time transmission and time-indexed report display.
Stated Advantages
Enables clinician or physician access to movement data, quantified symptom severity, quantified efficacy, and system output for entering new therapy or treatment parameters.
Determines quantified efficacy of a drug dose or drug pump or DBS therapy or treatment parameters at alleviating the subject’s movement disorder symptoms and supports deciding whether the therapy or treatment parameters should be changed.
Generates time-indexed report data providing an ordered measure of how data or a subject’s symptoms change over time.
Allows the new drug dose or new therapy or treatment parameters to be entered into the drug pump or DBS device based at least in part on the analysis results.
Documented Applications
Remote monitoring of movement-disorder symptoms outside a clinic, including recording movement data and quantified symptom severity over time with time-indexed reports.
Tracking and analyzing treatment efficacy and determining whether to adjust therapy or treatment parameters for a subject’s movement disorder symptoms.
Providing a clinician/physician interface for review of movement data, quantified symptom severity, quantified efficacy, and system output and for entering updated therapy parameters.
Support for subject journal or diary input as part of movement-disorder monitoring, and correlation of such entries with monitoring data for reporting and analysis [procedural detail omitted for safety].
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