Movement disorder therapy system, devices and methods, and intelligent methods of tuning

• US 20140074179A1
• Filed: 06/15/2013
• Published: 03/13/2014
• Est. Priority Date: 09/10/2012
• Status: Active Grant

• Current Assignee: Great Lakes Neurotechnologies Inc.
• Original Assignee: Great Lakes Neurotechnologies Inc.
• Inventors: Heldman, Dustin A, Pulliam, Christopher L, Giuffrida, Joseph P, Mera, Thomas O
• Granted Patent: US 9,211,417 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 2560/0456 Apparatus provided with a docking unit
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/1101 Detecting tremor
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/1124 Determining motor skills
• CPC Class Codes: A61B 5/1125 Grasping motions of hands
• CPC Class Codes: A61B 5/4082 Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6825 Hand
• CPC Class Codes: A61B 5/6887 mounted on external non-worn devices, e.g. non-medical devices
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36067 : Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36082 : Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36132 : using patient feedback
• CPC Class Codes: A61N 1/36135 : using physiological parameters
• CPC Class Codes: A61N 1/36139 : with automatic adjustment
• CPC Class Codes: A61N 1/37235 : Aspects of the external programmer
• CPC Class Codes: A61N 1/37247 : User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37282 : characterised by communication with experts in remote locations using a network
• CPC Class Codes: G16H 20/70 : relating to mental therapies, e.g. psychological therapy or autogenous training
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/50 : for simulation or modelling of medical disorders

Abstract

The present invention relates to methods for tuning treatment parameters in movement disorder therapy systems. The present invention further relates to a system for screening patients to determine viability as candidates for certain therapy modalities, such as deep brain stimulation (DBS). The present invention still further provides methods of quantifying movement disorders for the treatment of patients who exhibit symptoms of such movement disorders including, but not limited to, Parkinson'"'"'s disease and Parkinsonism, Dystonia, Chorea, and Huntington'"'"'s disease, Ataxia, Tremor and Essential Tremor, Tourette syndrome, stroke, and the like. The present invention yet further relates to methods of tuning a therapy device using objective quantified movement disorder symptom data acquired by a movement disorder diagnostic device to determine the therapy setting or parameters to be provided to the subject via his or her therapy device. The present invention also provides treatment and tuning remotely, allowing for home monitoring of subjects.

Claims

1. A method of tuning a movement disorder therapy system comprising steps of:

providing a movement disorder diagnostic device to a subject having a deep brain stimulation (DBS) device with a first level of DBS parameters, the movement disorder diagnostic device comprising at least one physiological or movement sensor having a signal, and a processor comprising an algorithm;

instructing the subject to perform at least one movement disorder test(s) while the subject is undergoing DBS therapy or is under the effects of DBS therapy;

measuring and quantifying motor symptoms of the subject based at least in part on the signal from the at least one physiological or movement sensor(s) during the at least one movement disorder test(s);

entering data corresponding to the subject'"'"'s measured and quantified motor symptoms into an algorithm;

providing, with the algorithm, a second level of DBS parameters based at least in part on the data entered into the algorithm; and

entering the second level of DBS parameters into the subject'"'"'s DBS device such that the subject'"'"'s DBS device operates under the second level of DBS parameters.

2. The method of claim 1, wherein the second level of DBS parameters corresponds to a quantifiable decrease in the severity and/or occurrence of at least one motor symptom.

3. The method of claim 1, wherein the second level of DBS parameters corresponds to a quantifiable decrease in the severity and/or occurrence of at least one side effect.

4. The method of claim 1, wherein the second level of DBS parameters corresponds to an increased ability for the subject to perform at least one activity of daily living.

5. The method of claim 1, wherein the second level of DBS parameters is automatically entered into the subject'"'"'s therapy device.

6. The method of claim 1, wherein the data corresponding to the subject'"'"'s measured and quantified motor symptoms and/or the second level of DBS parameters are displayed visually for review.

7. The method of claim 6, wherein the data and/or second level of DBS parameters are reviewed and approved by a clinician, physician or technician before being entered into the subject'"'"'s therapy device.

8. A method of tuning a movement disorder therapy system comprising steps of:

providing a movement disorder diagnostic device to a subject having a deep brain stimulation (DBS) device with a first level of DBS parameters, the movement disorder diagnostic device comprising at least one physiological or movement sensor having a signal, and a processor comprising an algorithm;

instructing the subject to perform at least one movement disorder test(s) while the subject is undergoing DBS therapy or is under the effects of DBS therapy;

measuring and quantifying motor symptoms of the subject based at least in part on the signal from the at least one physiological or movement sensor(s) during the at least one movement disorder test(s);

entering data corresponding to the subject'"'"'s measured and quantified motor symptoms into an algorithm;

determining, with the algorithm, at least two optional groups of DBS parameters, each optional group of parameters corresponding to a different desired outcome or constraint;

selecting one of the at least two optional groups of DBS parameters; and

entering the selected optional group of DBS parameters into the subject'"'"'s DBS device such that the subject'"'"'s DBS device operates under the second level of DBS parameters.

9. The method of claim 8, wherein the at least two optional groups of DBS parameters each correspond to a different motor symptom, and the selected group of parameters corresponds to a quantifiable decrease in the severity and/or occurrence of the selected motor symptom.

10. The method of claim 8, wherein at least one of the at least two optional groups of DBS parameters corresponds to a motor symptom, and at least one of the at least two optional groups of DBS parameters corresponds to a side effect, and the selected group of parameters corresponds to a quantifiable decrease in the severity and/or occurrence of the selected motor symptom or side effect.

11. The method of claim 8, wherein at least one of the at least two optional groups of DBS parameters corresponds to an activity of daily living, and selecting that group corresponds to an increase in the subject'"'"'s ability to perform the selected activity.

12. The method of claim 8, wherein the user is able to select a different group of optional parameters based at least in part on an activity the subject wishes to perform or a symptom or side effect that is occurring.

13. The method of claim 8, wherein the selected optional group of DBS parameters is automatically entered into the subject'"'"'s therapy device.

14. The method of claim 13, wherein the data corresponding to the subject'"'"'s measured and quantified motor symptoms and/or the selected optional group of DBS parameters are displayed visually for review, and the displayed data and/or second level of DBS parameters are reviewed and approved by a clinician, physician or technician before being entered into the subject'"'"'s therapy device.

15. A method of tuning a movement disorder therapy system comprising steps of:

providing a movement disorder diagnostic device to a subject having a deep brain stimulation (DBS) device with a first level of DBS parameters, the movement disorder diagnostic device comprising at least one physiological or movement sensor having a signal, and a processor comprising an algorithm;

instructing the subject to perform at least one movement disorder test(s) while the subject is undergoing DBS therapy or is under the effects of DBS therapy;

measuring and quantifying motor symptoms of the subject based at least in part on the signal from the at least one physiological or movement sensor(s) during the at least one movement disorder test(s);

entering data corresponding to the subject'"'"'s measured and quantified motor symptoms into an algorithm;

providing, with the algorithm, a second level of DBS parameters based at least in part on the data entered into the algorithm; and

automatically entering the second level of DBS parameters into the subject'"'"'s DBS device such that the subject'"'"'s DBS device operates under the second level of DBS parameters.

16. The method of claim 15, wherein the at least two optional groups of DBS parameters each correspond to a different motor symptom, and the combined group of DBS parameters corresponds to a quantifiable decrease in the severity and/or occurrence of the selected motor symptom.

17. The method of claim 15, wherein at least one of the at least two optional groups of DBS parameters corresponds to a motor symptom, and at least one of the at least two optional groups of DBS parameters corresponds to a side effect, and the combined group of DBS parameters corresponds to a quantifiable decrease in the severity and/or occurrence of the selected motor symptom(s) and/or side effect(s).

18. The method of claim 15, wherein at least one of the at least two optional groups of DBS parameters corresponds to an activity of daily living, and the combined group of DBS parameters corresponds to an increase in the subject'"'"'s ability to perform the selected activity based on the selected activity and at least one other selected activity, symptom or side effect.

19. The method of claim 15, wherein the data corresponding to the subject'"'"'s measured and quantified motor symptoms and/or the second level of DBS parameters are displayed visually for review.

20. The method of claim 19, wherein the data and/or second level of DBS parameters are reviewed and approved by a clinician, physician or technician before being entered into the subject'"'"'s therapy device.