Deep brain stimulation system and method with multi-modal, multi-symptom neuromodulation

Patent metadata

Field	Value
Publication number	US-11318311-B2
Application number	US-202017002136-A
Country	US
Kind code	B2
Filing date	Aug 25, 2020
Priority date	Oct 21, 2016
Publication date	May 3, 2022
Grant date	May 3, 2022

Abstract

Described here is a deep brain stimulation (“DBS”) approach that targets several relevant nodes within brain circuitry, while monitoring multiple symptoms for efficacy. This approach to multi-symptom monitoring and stimulation therapy may be used as an extra stimulation setting in extant DBS devices, particularly those equipped for both stimulation and sensing. The therapeutic efficacy of DBS devices is extended by optimizing them for multiple symptoms (such as sleep disturbance in addition to movement disorders), thus increasing quality of life for patients.

First claim

What is claimed is:

1. A method for controlling a sleep pattern of a subject, comprising the steps of:
receiving electrical data obtained from a deep brain stimulator (DBS) implanted in a subcortical structure including a globus pallidus of a brain of the subject;
determining that the subject is in an awake state based on analyzing the electrical data from the subcortical structure based on first phase amplitude coupling (PAC) data from the globus pallidus;
analyzing the electrical data from the DBS implanted in the subcortical structure to identify second PAC data,
the second PAC data being reduced compared to the first PAC data from the awake state;

determining that the subject is in an NREM sleep stage based on identifying at least one of a K complex or a spindle in the second PAC data and; and
stimulating, based on determining that the subject is in the NREM sleep stage, the subcortical structure of the brain of the subject by applying a patterned stimulation to the subcortical structure with a stimulation frequency of 10 Hz to at least one of induce sleep or awaken the subject.

2. The method of claim 1 , wherein the patterned stimulation includes a charge balanced pulse train comprising a maximal energy delivered at a center frequency Fc to amplify oscillations with center frequency Fc.

3. The method of claim 2 , further comprising identifying a phase angle of the electrical data associated with a maximum amplification of oscillations with center frequency Fc, and
stimulating the subcortical structure of the brain of the subject at the identified phase angle using at least one electrode of the DBS.

4. The method of claim 1 , wherein the globus pallidus includes at least one of a globus pallidus internal (GPI) segment, a globus pallidus external (GPe) segment, and the subcortical structure further includes one of: a subthalamic nucleus (STN) or a thalamus.

5. The method of claim 1 , wherein the electrical data comprises a plurality of frequency bands, and
wherein determining that the subject is in the NREM sleep stage further comprises:
determining that the subject is in the NREM sleep stage based on calculating a relative power associated with each of the plurality of frequency bands.

6. The method of claim 1 , wherein, when the patterned stimulation has been applied to induce sleep, the method further comprises:
adjusting control of the DBS to reduce the patterned stimulation based on determining that the subject is in the NREM sleep stage.

7. The method of claim 1 , further comprising:
stopping application of the patterned stimulation,
receiving further electrical data obtained from the subcortical structure of the brain of the subject,
determining that the subject is no longer in the NREM sleep stage based on analyzing the further electrical data, and
resuming the patterned stimulation of the DBS based on determining that the subject is no longer in the NREM sleep stage.

8. The method of claim 1 , wherein determining that the subject is in the NREM sleep stage based on analyzing the electrical data further comprises:
determining that the subject is asleep during a preprogrammed waking period, and
adjusting control of the DBS based on determining that the subject is in the NREM sleep stage by transmitting a signal from the DBS to alert the subject to wake up.

9. The method of claim 1 , wherein determining that the subject is in the NREM sleep stage includes determining a power of activity of the electrical data in a frequency range of 160 to 240 Hz.

10. The method of claim 1 , wherein the stimulation frequency of 10 Hz reduces body movements of the subject.

11. The method of claim 1 , further comprising recording the electrical data using the DBS.

12. The method of claim 1 , wherein stimulating the subcortical structure is performed at a different site than a site for receiving the electrical data from the subcortical structure.

13. The method of claim 1 , wherein stimulating the subcortical structure of the brain of the subject includes enhancing sleep metrics including at least one of sleep efficiency, REM start time, number of sleep cycles, or a number of times a REM stage sleep occurs.

14. The method of claim 1 , further comprising:
determining that the subject is asleep during a preprogrammed waking period, and
alerting, based on determining that the subject is asleep during the preprogrammed waking period, the patient by performing at least one of:
sending a signal to an external device for the subject to wake up, or
triggering a different set of stimulation parameters to interfere with the subject's transition into sleep.

15. The method of claim 14 , wherein the external device includes at least one of a patient programmer or a smart watch.

16. A system for controlling a sleep pattern of a subject, comprising a controller including a processor and instructions that, when executed by the processor, configure the system to:
receive electrical data obtained from a deep brain stimulator (DBS) implanted in a subcortical structure including a globus pallidus of a brain of the subject;
determine that the subject is in an awake state based on analyzing the electrical data from the subcortical structure based on first phase amplitude coupling (PAC) data from the globus pallidus;
analyze the electrical data from the DBS implanted in the subcortical structure to identify second PAC data,
the second PAC data being reduced compared to the first PAC data from the awake state;

determine that the subject is in an NREM sleep stage based on identifying at least one of a K complex or a spindle in the second PAC data and; and
stimulate the subcortical structure of the brain of the subject by applying a patterned stimulation to the subcortical structure with a stimulation frequency of 10 Hz to at least one of induce sleep or awaken the subject based on determining that the subject is in the NREM sleep stage.

17. The system of claim 16 , wherein the patterned stimulation includes a charge balanced pulse train comprising a maximal energy delivered at a center frequency Fc to amplify oscillations with center frequency Fc.

18. The system of claim 17 , wherein the processor is further configured to identify a phase angle of the electrical data associated with a maximum amplification of oscillations with center frequency Fc, and
stimulate the subcortical structure of the brain of the subject at the identified phase angle using at least one electrode of the DBS.

19. The system of claim 16 , wherein the globus pallidus includes at least one of a globus pallidus internal (GPI) segment, a globus pallidus external (GPe) segment, and the subcortical structure further includes one of: a subthalamic nucleus (STN) or a thalamus.

20. The system of claim 16 , wherein the electrical data comprises a plurality of frequency bands, and wherein the processor is further configured to determine that the subject is in the NREM sleep stage based on calculating a relative power associated with each of the plurality of frequency bands.

21. The system of claim 16 , wherein, when the patterned stimulation has been applied to induce sleep, the processor is further configured to:
adjust control of the DBS to reduce the patterned stimulation based on determining that the subject is in the NREM sleep stage.

22. The system of claim 16 , wherein the processor is further configured to:
stop application of the patterned stimulation,
receive further electrical data obtained fro

Assignees

• Univ Minnesota

Inventors

• Molnar Gregory Frederick
• Johnson Luke
• Sanabria David Escobar
• Bello Ii Edward Mark
• Vitek Jerrold L
• Johnson Matthew D

Classifications

• A61B5/293

  Invasive · CPC title

• A61B2503/42

  for laboratory research · CPC title

• A61N1/36139 Primary

  with automatic adjustment · CPC title

• G16H50/20

  for computer-aided diagnosis, e.g. based on medical expert systems · CPC title

• A61N2007/0026

  Stimulation of nerve tissue · CPC title