Movement disorder therapy system, devices and methods of tuning

• US 9,393,418 B2
• Filed: 04/12/2013
• Issued: 07/19/2016
• Est. Priority Date: 06/03/2011
• 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): SOREY, ROBERT A
• Application Number:
  US13/861,790
• Publication Number:
  US 20140005743A1
• Time in Patent Office: 1,194 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

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 if they are viable candidates for certain therapy modalities. 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, 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 allow a clinician, technician or physician to determine the therapy setting or parameters to be provided to the subject via his or her therapy device.

Claims

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

providing a movement disorder diagnostic device to a subject with an implanted deep brain stimulation (DBS) device operable according to adjustable DBS parameters,

wherein the movement disorder diagnostic device comprises at least one physiological or movement sensor capable of generating a signal, and the DBS parameters include one or more of stimulation frequency, amplitude, pulse width, pulse wavelength, waveform type, and contact configuration;

supplying, by the DBS device, a stimulation current to the subject'"'"'s brain under a set of first level DBS parameters;

instructing the subject to perform a first movement disorder test while the subject is undergoing DBS therapy or is under the effects of DBS therapy,

wherein the first movement disorder test corresponds to the set of first level DBS parameters of the DBS therapy;

measuring, by the movement disorder diagnostic device, symptomatic movement of the subject to obtain movement data based at least in part on the generated signal from the at least one physiological or movement sensor during the first movement disorder test;

supplying, by the DBS device, a stimulation current to the subject'"'"'s brain under a set of second level DBS parameters;

instructing the subject to perform a second movement disorder test while the subject is undergoing DBS therapy or is under the effects of DBS therapy, wherein the second movement disorder test corresponds to the set of second level DBS parameters of the DBS therapy;

measuring, by the movement disorder diagnostic device, symptomatic movement of the subject to obtain movement data based at least in part on the generated signal from the at least one physiological or movement sensor during the second movement disorder test;

transmitting, by the movement disorder diagnostic device, the measured movement data to a processor;

quantifying, by the processor, the subject'"'"'s motor symptoms based on the measured movement data;

combining, by the processor, data corresponding to the subject'"'"'s measured and quantified motor symptoms from the first movement disorder test, data corresponding to at least two test parameters from the first movement disorder test, data corresponding to the subject'"'"'s measured and quantified motor symptoms from the second movement disorder test, and data corresponding to the set of second level DBS parameters;

generating, by the processor, based on the combined data, a tuning map comprising a two-dimensional representation of a three-dimensional graph that illustrates a correlation between the test parameters and the data corresponding to the subject'"'"'s measured and quantified motor symptoms;

displaying, on a display or in a report, the generated tuning map for viewing by a clinician, technician or physician;

determining, by the clinician, technician or physician, based at least in part on the tuning map, a set of new level DBS parameters to alter the subject'"'"'s performance on at least one movement disorder test;

entering, automatically by the device with a processor or manually by the clinician, technician or physician, the set of new level DBS parameters into a programmer device in communication with the subject'"'"'s DBS device such that the subject'"'"'s DBS device operates under the set of new level DBS parameters; and

supplying, by the DBS device, a stimulation current to the subject'"'"'s brain under the set of new level DBS parameters to provide altered DBS therapy to the subject.

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 clinician, technician or physician determines the set of new level 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 clinician, technician or physician determines the set of new level 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 clinician, technician or physician determines the set of new level 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,

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:

providing a movement disorder diagnostic device to a subject with an implanted deep brain stimulation (DBS) device operable according to adjustable DBS parameters,

wherein the movement disorder diagnostic device comprises at least one physiological or movement sensor capable of generating a signal, and the DBS parameters include one or more of stimulation frequency, amplitude, pulse width, pulse wavelength, waveform type, and contact configuration;

supplying, by the DBS device, a stimulation current to the subject'"'"'s brain under a set of DBS parameters;

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

wherein the at least one movement disorder test corresponds to the set DBS parameters of the DBS therapy;

measuring, by the movement disorder diagnostic device, symptomatic movement of the subject to obtain movement data based at least in part on the generated signal from the at least one physiological or movement sensor during the at least one movement disorder test;

transmitting, by the movement disorder diagnostic device, the measured movement data to a processor;

quantifying, by the processor, the subject'"'"'s motor symptoms based on the measured movement data;

combining, by the processor, data corresponding to the subject'"'"'s measured and quantified motor symptoms with data corresponding to at least two test parameters;

generating, by the processor, based on the combined data, a tuning map that graphically depicts coded indicators each relating to an objective measured and quantified motor symptom score,

wherein the indicators are coded by one or more of color, pattern, or number representing quantified score;

displaying, on a display or in a report, the generated tuning map for viewing by a clinician, technician or physician;

repeating the supplying, instructing, measuring, transmitting, quantifying, combining, generating, and displaying steps at least one more time, each time with the subject'"'"'s DBS device operating under a set of different level DBS parameters, resulting in the further population of the tuning map;

determining, by the clinician, technician or physician, based at least in part on the tuning map, a set of new level DBS parameters to alter the subject'"'"'s performance on at least one movement disorder test;

entering, automatically by the device with a processor or manually by the clinician, technician or physician, the set of new level DBS parameters into a programmer device in communication with the subject'"'"'s DBS device such that the subject'"'"'s DBS device operates under the set of new level DBS parameters; and

supplying, by the DBS device, a stimulation current to the subject'"'"'s brain under the set of new level DBS parameters to provide altered DBS therapy to the subject.

9. The method of claim 8, further comprising a step of repeating the supplying, instructing, measuring, transmitting, quantifying, combining, generating, and displaying steps a further time,

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 generated 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 clinician, technician or physician determines the set of new level 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 clinician, technician or physician determines the set of new level 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 clinician, technician or physician determines the set of new level 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 supplying, instructing, measuring, transmitting, quantifying, combining, generating, and displaying steps yet another time,

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:

providing a movement disorder diagnostic device to a subject with an implantable deep brain stimulation (DBS) device operable according to adjustable DBS parameters,

wherein the movement disorder diagnostic device comprises at least one physiological or movement sensor capable of generating a signal, and the DBS parameters include one or more of stimulation frequency, amplitude, pulse width, pulse wavelength, waveform type, and contact configuration;

supplying, by the DBS device, a stimulation current to the subject'"'"'s brain under a set of DBS parameters;

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

wherein the at least one movement disorder test corresponds to the set of DBS parameters of the DBS therapy;

measuring, by the movement disorder diagnostic device, symptomatic movement of the subject to obtain movement data based at least in part of the generated signal from the at least one physiological or movement sensor during the at least one movement disorder test;

transmitting, by the movement disorder diagnostic device, the measured movement data to a processor;

quantifying, by the processor, the subject'"'"'s motor symptoms based on the measured movement data;

combining, by the processor, data corresponding to the subject'"'"'s measured and quantified motor symptoms with data corresponding to at least two test parameters;

generating, by the processor, based on the combined data, a tuning map that graphically depicting one or more of sensor recordings, subject responses, subject perceptions, clinician observations, or scores derived at least in part from the generated signal from the at least one physiological or movement sensor during the at least one movement disorder test;

displaying, on a display or in a report, the generated tuning map for viewing by a clinician, technician or physician;

repeating the supplying, instructing, measuring, transmitting, quantifying, combining, generating, and displaying steps at least two more times, each time with the subject'"'"'s DBS device operating under a set of different level DBS parameters, resulting in the further population of the tuning map;

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

entering, automatically by the device with a processor or manually by the clinician, technician or physician, the set of previously tested or new level DBS parameters to the subject'"'"'s DBS device; and

supplying, by the DBS device, a stimulation current to the subject'"'"'s brain under the set of previously tested or new level DBS parameters to provide DBS therapy to the subject.

16. The method of claim 15, further comprising a step of repeating the supplying, instructing, measuring, transmitting, quantifying, combining, generating, and displaying steps a further time,

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 generated 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 clinician, technician or physician chooses or determines the set of previously tested or new level 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 clinician, technician or physician chooses or determines the set of previously tested or new level 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 clinician, technician or physician chooses or determines the set of previously tested or new level 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.