Movement disorder therapy system and methods of tuning remotely, intelligently and/or automatically

• US 9,522,278 B1
• Filed: 12/09/2015
• Issued: 12/20/2016
• 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
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US14/963,687
• Time in Patent Office: 377 Days
• Field of Search: 607/2, 607/9, 607/45, 128/898
• US Class Current: 1/1
• 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 5/1124 Determining motor skills
• 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: 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: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices

Abstract

The present invention relates to methods for remotely and intelligently tuning movement disorder of therapy systems. 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 remotely and intelligently or automatically tuning a therapy device using objective quantified movement disorder symptom data to determine the therapy setting or parameters to be transmitted and provided to the subject via his or her therapy device. The present invention also provides treatment and tuning intelligently, automatically and remotely, allowing for home monitoring of subjects.

Claims

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

instructing a subject having a deep brain stimulation (DBS) device with a first level of DBS parameters to perform a first movement disorder test while the subject is undergoing DBS therapy or is under the effects of DBS therapy;

having a physician, clinician, technician or device with sensors determine a score to quantify a first motor symptom(s) of the subject from the first movement disorder test;

operating the subject'"'"'s DBS device under a second level of DBS parameters;

instructing the subject to perform at least one more movement disorder test while the subject is undergoing DBS therapy or is under the effects of DBS therapy under the second level of DBS parameters;

having a physician, clinician, technician or device with sensors determine a score to quantify a second motor symptom(s) of the subject during the at least one more movement disorder test;

combining, with a processor, data corresponding to the subject'"'"'s first motor symptom score, data corresponding to the test parameter(s) from the first movement disorder test and/or the first level of DBS parameter(s), data corresponding to the subject'"'"'s second motor symptom score and data corresponding to the test parameter(s) from the another movement disorder test and/or the second level of DBS parameter(s) to generate a tuning map for viewing by a clinician, technician or physician comprising a two-dimensional representation of a three-dimensional graph that illustrates a correlation between the test parameter(s) and/or DBS parameter(s), and the data corresponding to the subject'"'"'s quantified motor symptom(s) scores;

a clinician, technician or physician determining, based at least in part on the tuning map, a new level of DBS parameters;

entering the new level of DBS parameters into the subject'"'"'s DBS device such that the subject'"'"'s DBS device operates under the new level of DBS parameters; and

the DBS device supplies a stimulation current to the subject'"'"'s brain under the new level of DBS parameters to provide improved DBS therapy.

2. The method of claim 1, wherein the tuning map comprises a scatter plot of symptom severity scores, and the horizontal and vertical axes of the tuning map each represent either individual therapy parameters, or groupings of multiple therapy parameters.

3. The method of claim 2, wherein the vertical axis of the tuning map represents stimulation current amplitude and the horizontal axis represents different parameter groupings, the parameter groupings including different settings or values for parameters selected from stimulation frequency, amplitude, pulse width, pulse wavelength, waveform type, or contact configuration.

4. The method of claim 1, wherein the physician(s), clinician(s), or technician(s) determines the new level of DBS parameters based on the constraint of achieving at least a 50% reduction of the severity of at least one movement disorder symptom.

5. The method of claim 1, wherein the physician(s), clinician(s), or technician(s) determines the new level of DBS parameters based on the constraint of achieving at least a 50% reduction of at least one side effect from DBS therapy and/or medication.

6. The method of claim 1, wherein the physician(s), clinician(s), or technician(s) determines the new level of DBS parameters based on the constraint of achieving an improvement in battery life of the DBS device while reducing or not increasing the severity of at least one movement disorder symptom.

7. The method of claim 2, further comprising a step of instructing the subject to perform a third movement disorder test, and wherein the tuning map is a two-dimensional representation of a three-dimensional graph that provides a correlation between at least two test parameters and the results of at least three movement disorder tests.

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

instructing a subject having a deep brain stimulation (DBS) device with a first level of DBS parameters to perform a first movement disorder test while the subject is undergoing DBS therapy or is under the effects of DBS therapy;

having a physician, clinician, technician or device with sensors determine a score to quantify a first motor symptom(s) of the subject from the first movement disorder test;

operating the subject'"'"'s DBS device under a second level of DBS parameters;

instructing the subject to perform at least one more movement disorder test while the subject is undergoing DBS therapy or is under the effects of DBS therapy under the second level of DBS parameters;

having a physician, clinician, technician or device with sensors determine a score to quantify a second motor symptom(s) of the subject during the at least one more movement disorder test;

combining, with a processor, data corresponding to the subject'"'"'s first quantified motor symptom(s) score, data corresponding to the test parameter(s) from the first movement disorder test and/or the first level of DBS parameter(s), data corresponding to the subject'"'"'s second quantified motor symptom(s) score and data corresponding to the test parameter(s) from the another movement disorder test and/or the second level of DBS parameter(s) to generate a tuning map for viewing by a clinician, technician or physician comprising a two-dimensional representation of a three-dimensional graph wherein the tuning map graphically depicts coded indicators each relating to a quantified motor symptom scores, where the indicators are coded by one or more of color, pattern, or number representing each quantified score;

a clinician, technician or physician determining, based at least in part on the tuning map, a new level of DBS parameters;

entering the new level of DBS parameters into the subject'"'"'s DBS device such that the subject'"'"'s DBS device operates under the new level of DBS parameters; and

the DBS device supplies a stimulation current to the subject'"'"'s brain under the new level of DBS parameters to provide improved DBS therapy.

9. The method of claim 8, further comprising a step of repeating the testing, measuring and quantifying, and combining steps a further time, and wherein the tuning map is a two-dimensional representation of a three-dimensional graph that provides a correlation between at least two test parameters and the results of at least three movement disorder tests.

10. The method of claim 8, wherein the tuning map is populated entirely by scores derived at least in part from the signal from the at least one physiological or movement sensor-during the at least one movement disorder test and no human observation or calculation is required to populate the tuning map.

11. The method of claim 8, wherein the physician(s), clinician(s), or technician(s) determines the new level of DBS parameters based on the constraint of achieving at least a 50% reduction of the subject'"'"'s severity of at least one movement disorder symptom.

12. The method of claim 8, wherein the physician(s), clinician(s), or technician(s) determines the new level of DBS parameters based on the constraint of achieving at least a 50% reduction of at least one side effect of the subject from DBS therapy and/or medication.

13. The method of claim 8, wherein the physician(s), clinician(s), or technician(s) determines the new level of DBS parameters based on the constraint of achieving an improvement in battery life of the DBS device while reducing or not increasing the severity of at least one movement disorder symptom.

14. The method of claim 9, further comprising a step of repeating the testing, measuring and quantifying, and combining steps yet another time, and wherein the tuning map is a two-dimensional representation of a three-dimensional graph that provides a correlation between at least two test parameters and the results of at least four movement disorder tests.

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

instructing a subject having a deep brain stimulation (DBS) device with a first level of DBS parameters to perform a first movement disorder test while the subject is undergoing DBS therapy or is under the effects of DBS therapy;

having a physician, clinician, technician or device with sensors determine a score to quantify a first motor symptom(s) of the subject from the first movement disorder test;

operating the subject'"'"'s DBS device under a second level of DBS parameters;

instructing the subject to perform at least one more movement disorder test while the subject is undergoing DBS therapy or is under the effects of DBS therapy under the second level of DBS parameters;

having a physician, clinician, technician or device with sensors determine a score to quantify a second motor symptom(s) of the subject during the at least one more movement disorder test;

combining, with a processor, data corresponding to the subject'"'"'s first quantified motor symptom(s) score, data corresponding to the test parameter(s) from the first movement disorder test and/or the first level of DBS parameter(s), data corresponding to the subject'"'"'s second quantified motor symptom(s) score and data corresponding to the test parameter(s) from the another movement disorder test and/or the second level of DBS parameter(s) to generate a tuning map for viewing by a clinician, technician or physician comprising a two-dimensional representation of a three-dimensional graph, the tuning map further graphically depicting one or more of sensor recordings, subject responses, subject perceptions, clinician observations, clinician scores or device scores;

a clinician, technician or physician determining, based at least in part on the tuning map, a new level of DBS parameters;

entering the new level of DBS parameters into the subject'"'"'s DBS device such that the subject'"'"'s DBS device operates under the new level of DBS parameters; and

the DBS device supplies a stimulation current to the subject'"'"'s brain under the new level of DBS parameters to provide improved DBS therapy.

16. The method of claim 15, further comprising a step of repeating the testing, measuring and quantifying, and combining steps a further time, and wherein the tuning map is a two-dimensional representation of a three-dimensional graph that provides a correlation between at least two test parameters and the results of at least four movement disorder tests.

17. The method of claim 15, wherein the tuning map is populated entirely by scores derived at least in part from the signal from the at least one physiological or movement sensor during the at least one movement disorder test and no human observation or calculation is required to populate the tuning map.

18. The method of claim 15, wherein the physician(s), clinician(s), or technician(s) chooses or determines the previously tested or new level of DBS parameters based on the constraint of achieving at least a 50% reduction of the subject'"'"'s severity of movement disorder symptoms.

19. The method of claim 15, wherein the physician(s), clinician(s), or technician(s) chooses or determines the previously tested or new level of DBS parameters based on the constraint of achieving at least a 50% reduction of the subject'"'"'s side effects from DBS therapy and/or medication.

20. The method of claim 15, wherein the physician(s), clinician(s), or technician(s) chooses or determines the previously tested or new level of DBS parameters based on the constraint of achieving an improvement in battery life of the DBS device while reducing or not increasing the severity of at least one movement disorder symptom.