Device and method for monitoring and assessment of movement disorder symptoms

• US 10,085,689 B1
• Filed: 07/15/2016
• Issued: 10/02/2018
• Est. Priority Date: 06/18/2010
• Status: Active Grant

• Current Assignee: Great Lakes Neurotechnologies Inc.
• Original Assignee: Great Lakes Neurotechnologies Inc.
• Inventors: Giuffrida, Joseph P., Heldman, Dustin A., Mera, Thomas O.
• Primary Examiner(s): Hall, Deanna K
• Application Number:
  US15/210,990
• Time in Patent Office: 809 Days
• Field of Search: 600595
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61B 5/1101 Detecting tremor
• CPC Class Codes: A61B 5/4082 Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: G16H 40/67 for remote operation

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.

Claims

1. A method of monitoring the efficacy of either a drug or deep brain stimulation (DBS) therapy during treatment at alleviating a subject'"'"'s Parkinson'"'"'s disease symptoms, the method comprising the steps of:

a) administering at least one dose of a drug or DBS therapy treatment to the subject;

b) applying at least one sensor to the subject over a period of time, the sensor adapted for measuring movement of at least one of the subject'"'"'s extremities and to be in wired or wireless communication with a processor, the sensor and processor being part of a movement disorder monitoring device further comprising a memory, the processor adapted to process and analyze data collected with the at least one sensor and further to quantify severity of the subject'"'"'s movement disorder symptoms;

c) using the at least one sensor to collect movement data from the subject over a period of time;

d) preprocessing measured movement data with the processor of the movement disorder monitoring device;

e) quantifying severity of the subject'"'"'s movement disorder symptoms with the processor of the movement disorder monitoring device;

f) recording, by the subject, a journal or diary entry through an input on the movement disorder monitoring device at the subject'"'"'s discretion;

g) transmitting the preprocessed movement data, quantified symptom severity, and/or journal or diary entry to a remote database;

h) analyzing the preprocessed movement data, quantified symptom severity, and/or journal or diary entry with a second processor to determine the efficacy of the drug or DBS therapy at alleviating the subject'"'"'s Parkinson'"'"'s disease symptoms and to determine whether the dose of drug or DBS therapy administered to the subject should be changed; and

i) adjusting the subject'"'"'s dose of drug or DBS parameters according to the results of the analysis.

2. The method of claim 1, wherein the processor of the movement disorder monitoring device is further adapted to wirelessly communicate with a remote database and interact with software or algorithms on the remote database to compare and/or correlate the subject'"'"'s preprocessed movement data, quantified symptom severity, and/or journal or diary entry with data on the database.

3. The method of claim 2, wherein the movement disorder monitoring device further comprises a touch-sensitive display adapted at least in part be programmed manually or remotely by a clinician or physician to provide instructions and display data and reports to the subject and at least in part for the subject to record journal or diary entries at the subject'"'"'s discretion.

4. The method of claim 1, wherein the preprocessed movement data, quantified symptom severity, and/or journal or diary entry are consolidated into a report via software on the second processor and indexed and displayed relative to time for viewing and/or analysis by a clinician, physician, and/or the subject to provide an ordered measure of how the data or a subject'"'"'s symptoms change over time.

5. The method of claim 4, wherein the step of adjusting the subject'"'"'s dose of drug or DBS parameters is performed by a clinician, physician, or the subject based at least in part on the time-indexed report to provide accurate adjustment, efficient optimization of treatment results, or to ensure a more constant level of treatment efficacy.

6. The method of claim 5, wherein the time-indexed report comprises a two-dimensional table, with time on one axis of the table and movement disorder assessment tasks on the other axis of the table and spaces in the table are then filled with a value that represents the severity of a subject'"'"'s movement disorder symptom at a given time and with respect to a given movement disorder assessment task.

7. The method of claim 6, wherein each space in the table may also be color-coded to represent the level of severity of a subject'"'"'s movement disorder symptoms at any given time for any given assessment task.

8. A method of monitoring the efficacy of a drug or deep brain stimulation (DBS) therapy during treatment at alleviating a specific subject'"'"'s Parkinson'"'"'s disease symptoms, the method comprising the steps of:

a) administering at least one dose of a drug or DBS therapy treatment to the specific subject;

b) applying at least one sensor to the specific subject, the at least one sensor adapted for measuring movement of at least one of the specific subject'"'"'s extremities and to be in wired or wireless communication with a processor, the sensor and processor being part of a movement disorder monitoring device, the processor adapted to store data and to correlate data between the movement disorder monitoring device and external devices;

c) using the at least one sensor to collect movement data from the specific subject over a period of time;

d) preprocessing measured movement data with the processor of the movement disorder monitoring device;

e) quantifying severity of the subject'"'"'s movement disorder symptoms with the processor of the movement disorder monitoring device;

f) recording, by the subject, a journal or diary entry through an input on the movement disorder monitoring device at the subject'"'"'s discretion;

g) analyzing the collected data to determine the efficacy of the drug or DBS therapy at alleviating the specific subject'"'"'s Parkinson'"'"'s disease symptoms and to determine whether the dose of drug or DBS therapy administered to the specific subject should be changed; and

h) adjusting the specific subject'"'"'s dose of drug or DBS parameters according to the results of the analysis,

wherein the movement disorder monitoring device is adapted to transmit measured data to a remote database in near real-time as data is collected from the subject and the preprocessed movement data, quantified symptom severity, and/or journal or diary entry are consolidated into a report via software on the second processor and indexed and displayed relative to time for viewing and/or analysis by a clinician, physician, and/or the subject to provide an ordered measure of how the data or a subject'"'"'s symptoms change over time.

9. The method of claim 8, wherein near real-time means that the time between starting of movement disorder monitoring data analysis and generation of the final report is less than 6 hours.

10. The method of claim 8, wherein near real-time means that the time between starting of movement disorder monitoring data analysis and generation of the final report is less than 3 hours.

11. The method of claim 10, wherein processor of the movement disorder monitoring device is further adapted to wirelessly communicate with a remote database and interact with software or algorithms on the remote database to compare and/or correlate the subject'"'"'s preprocessed movement data, quantified symptom severity, and/or journal or diary entry with data on the database.

12. The method of claim 11, wherein the movement disorder monitoring device further comprises a touch-sensitive display adapted at least in part be programmed manually or remotely by a clinician or physician to provide instructions and display data and reports to the subject and at least in part for the subject to record journal or diary entries at the subject'"'"'s discretion.

13. The method of claim 8, wherein the step of adjusting the subject'"'"'s dose of drug or DBS parameters is performed by a clinician, physician, or the subject based at least in part on the time-indexed report to provide accurate adjustment, efficient optimization of treatment results, or to ensure a more constant level of treatment efficacy.

14. A method of monitoring the efficacy of either a drug or deep brain stimulation (DBS) therapy during treatment at alleviating a specific subject'"'"'s Parkinson'"'"'s disease symptoms, the method comprising the steps of:

a) administering at least one dose of a drug or DBS therapy treatment to the specific subject;

b) applying at least one sensor to the specific subject, the sensor adapted for measuring movement of at least one of the subject'"'"'s extremities and to be in wired or wireless communication with a processor, the sensor and processor being part of a movement disorder monitoring device further comprising a memory, the processor adapted to process and analyze data collected with the at least one sensor and further to quantify severity of the subject'"'"'s movement disorder symptoms;

c) using the at least one sensor to collect movement data from the specific subject over a period of time;

d) preprocessing measured movement data with the processor of the movement disorder monitoring device;

e) quantifying severity of the subject'"'"'s movement disorder symptoms with the processor of the movement disorder monitoring device;

f) transmitting the preprocessed movement data and/or quantified symptom severity to a remote database;

g) analyzing the collected preprocessed movement data and/or the quantified symptom severity with a second processor to determine the efficacy of the drug or DBS therapy at alleviating the subject'"'"'s Parkinson'"'"'s disease symptoms and to determine whether the dose of drug or DBS therapy administered to the specific subject should be changed; and

h) adjusting the specific subject'"'"'s dose of drug or DBS parameters, if necessary, according to the results of the analysis,

wherein the movement disorder monitoring device is adapted to transmit preprocessed movement data and/or quantified symptom severity to the remote data base in near real-time as data is collected from the subject.

15. The method of claim 14, further comprising the step of recording, by the subject, a journal or diary entry through an input on the movement disorder monitoring device at the subject'"'"'s discretion, and the journal or diary entry is transmitted with or instead of the preprocessed movement data and/or quantified symptom severity.

16. The method of claim 15, wherein near real-time means that the time between starting of movement disorder monitoring data analysis and generation of the final report is less than 6 hours.

17. The method of claim 15, wherein near real-time means that the time between starting of movement disorder monitoring data analysis and generation of the final report is less than 3 hours.

18. The method of claim 17, wherein the processor of the movement disorder monitoring device is further adapted to wirelessly communicate with a remote database and interact with software or algorithms on the remote database to compare and/or correlate the subject'"'"'s preprocessed movement data, quantified symptom severity, and/or journal or diary entry with data on the database.

19. The method of claim 18, wherein the movement disorder monitoring device further comprises a touch-sensitive display adapted at least in part be programmed manually or remotely by a clinician or physician to provide instructions and display data and reports to the subject and at least in part for the subject to record journal or diary entries.