Closed-loop vibratory stimulation for treatment of spasticity

Abstract

The technology described herein is directed to methods and systems for the treatment of spasticity.

Description

CLOSED-LOOP VIBRATORY STIMULATION FOR TREATMENT OF SPASTICITYCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application No. 63 / 603,230 filed November 28, 2023, the contents of which are incorporated herein by reference in their entirety.TECHNICAL FIELD

[0002] The technology described herein relates to devices, systems, and methods for the treatment of spasticity.BACKGROUND

[0003] Spasticity, a condition characterized by muscle stiffness and involuntary contractions, commonly arises from neurological disorders like multiple sclerosis and cerebral palsy. Spasticity can negatively impact balance, coordination, movement control, and fine motor control. Many existing treatments are highly invasive or involve medication that may cause significant side effects.

[0004] In normal muscle function, the contraction of a first muscle results in a stretching of an opposing muscle. This stretching provides an inhibitory signal to the first muscle and causes the first muscle to relax, ending the intended movement. In spasticity, the opposing muscle does not stretch, or does not stretch enough. Therefore, the first muscle continues to contract and a spasm results.SUMMARY

[0005] The inventors have found that vibrations applied to either the first muscle or the opposing muscle can force muscle activation. If the vibrations are applied during a spastic contraction, the spasm process can be interrupted. Accordingly, described herein are devices and systems which utilize vibration to provide spastic muscles input that signals muscle relaxation or shortening and thereby interrupt spasticity.

[0006] In one aspect of any of the embodiments, described herein is a system or device comprising: a) at least two vibratory motors; b) at least one gyroscope; and c) at least one accelerometer.In some embodiments of any of the aspects, the system or device further comprises at least one of: d) at least one controller; e) at least one power source; and f) at least one body attachment means.

[0007] In some embodiments of any of the aspects, at least one body attachment means is a wrap or strap. In some embodiments of any of the aspects, at least one body attachment means is a wrap orstrap that fully encircles a limb. In some embodiments of any of the aspects, at least one body attachment means is a wrap or strap that fully encircles a limb above a joint. In some embodiments of any of the aspects, the joint is a wrist, an ankle, an elbow, or a knee. In some embodiments of any of the aspects, the at least one body attachment means is a warp or strap that fully encircles a part of the body. In some embodiments of any of the aspects, the part of the body is the thoracic cavity, abdomen, back, or cervical region.

[0008] In some embodiments of any of the aspects, the at least one body attachment means comprises a magnetic closure. In some embodiments of any of the aspects, at least one body attachment means comprises an adhesive surface.

[0009] In some embodiments of any of the aspects, the at least two vibratory motors are attached to or enclosed by at least one body attachment means. In some embodiments of any of the aspects, the at least two vibratory motors are attached to or enclosed by a first body attachment means such that a first vibratory motor can be positioned at the location of a tendon of the first muscle of a set of agonist-antagonist muscles and a second vibratory motor can positioned at the location of a tendon of a second muscle of the set of agonist-antagonist muscles.

[0010] In some embodiments of any of the aspects, a first body attachment means is provided markings to index the first body attachment means to a specific position on a body; and the at least two vibratory motors are non-movably attached to or are enclosed by the first body attachment means such that, when the body attachment means is indexed to the body, a first vibratory motor is positioned at the location of a tendon of an agonist muscle and a second vibratory motor can positioned at the location of a tendon of a corresponding antagonist muscle.

[0011] In some embodiments of any of the aspects, a first body attachment means is formed to fit and attach to a body in only one position; and the at least two vibratory motors are non-movably attached to or enclosed by the first body attachment means such that, when the body attachment means is attached to the body, a first vibratory motor is positioned at the location of a tendon of an agonist muscle and a second vibratory motor can positioned at the location of a tendon of a corresponding antagonist muscle.

[0012] In some embodiments of any of the aspects, the at least two vibratory motors are attached to or enclosed by a first body attachment means; and the first body attachment means comprises a rigid portion at the location of each of the at least two vibratory motors, wherein the rigid portion is or is configured to be more distal from the body than the at least two vibratory motors.

[0013] In some embodiments of any of the aspects, the at least two vibratory motors are implanted or injected in a subject.

[0014] In some embodiments of any of the aspects, the system or device comprises two or more body attachment means, each body attachment means comprising at least: d) at least two vibratory motors;e) at least one gyroscope; and f) at least one accelerometer.In some embodiments of any of the aspects, the at least two vibratory motors, at least one gyroscope, and at least one accelerometer of each body attachment means is in communication with and / or controllable by a single controller.

[0015] In some embodiments of any of the aspects, a first body attachment means is configured or placed above a first joint of a limb and a second body attachment means is configured or placed above a second joint of the limb. In some embodiments of any of the aspects, the system or device comprises a first body attachment means configured or placed to extend from above a first joint of a limb to above a second joint of the limb; wherein the first body attachment means comprises at least two vibratory motors, at least one gyroscope, and at least one accelerometer above the first joint of the limb and at least two vibratory motors, at least one gyroscope, and at least one accelerometer above the second joint of the limb. In some embodiments of any of the aspects, the first joint is a wrist and the second j oint is an elbow, or the first j oint is an ankle and the second j oint is a knee .

[0016] In some embodiments of any of the aspects, a portion of the at least two vibratory motors which is or is configured to be most distal from the body is rigid.

[0017] In some embodiments of any of the aspects, the system or device of any one of the preceding claims, comprises only two vibratory motors. In some embodiments of any of the aspects, the only two vibratory motors are attached to or enclosed by each body attachment means.

[0018] In some embodiments of any of the aspects, the controller and / or power source are physically connected to or connectable with one or more of the at least two vibratory motors, at least one gyroscope, and at least one accelerometer. In some embodiments of any of the aspects, the controller and / or power source are wirelessly connected to or connectable with one or more of the at least two vibratory motors, at least one gyroscope, and at least one accelerometer. In some embodiments of any of the aspects, the power source comprises a battery, a cord, and / or a wireless power source. In some embodiments of any of the aspects, the system or device further comprises at least one of a receiver, antenna, and / or transmitter.

[0019] In some embodiments of any of the aspects, the at least two vibratory motors are configured to provide vibration in the range of 60-100 Hz. In some embodiments of any of the aspects, the at least one gyroscope and at least one accelerometer are configured to detect movement of the body.

[0020] In some embodiments of any of the aspects, the controller is configured to activate at least one of the at least two vibratory motors when body motion is detected. In some embodiments of any of the aspects, the controller is configured to activate less than all of the at least two vibratory motors when body motion is detected. In some embodiments of any of the aspects, the controller is configured to separately control activation of each of the at least two vibratory motors when bodymotion is detected. In some embodiments of any of the aspects, the controller is configured to: classify a detected body movement; assign an agonist muscle position and antagonist muscle position for the classified detected body movement; and activate at least one vibratory motor at the location of the assigned antagonist muscle position. In some embodiments of any of the aspects, the controller is configured to: classify a detected body movement; assign an agonist muscle position and / or antagonist muscle position for the classified detected body movement; and activate at least one vibratory motor at the location of the assigned antagonist muscle position until the body movement a) slows below a threshold speed, b) changes direction or c) exhibits acceleration within certain bounds. In some embodiments of any of the aspects, the controller is configured to: classify a detected body movement; assign an agonist muscle position and antagonist muscle position for the classified detected body movement; activate at least one vibratory motor at the location of the assigned antagonist muscle position until the body movement changes direction or acceleration; and / or activate at least one vibratory motor at the location of the assigned agonist muscle position until the body movement slows below a threshold speed. In some embodiments of any of the aspects, the controller is configured to separately control activation of i) at least one vibratory motor at the location of the assigned antagonist muscle position and ii) at least one vibratory motor at the location of the assigned agonist muscle position.

[0021] In one aspect of any of the embodiments, described herein is a method of treating spasticity in a subject in need thereof, comprising: placing at least one body attachment means of a system or device described herein on the subject, or injecting or implanting the at least two vibration motors as described herein in the subject; whereby the at least one accelerometer and / or at least one gyroscope of the system or device detects body movement of the subject; the controller classifies the detected body movement and assigns an agonist muscle position and / or antagonist muscle position for the classified detected body movement; and the controller activates at least one vibratory motor at the location of the assigned antagonist or agonist muscle position.

[0022] In some embodiments of any of the aspects, the controller separately controls activation of each of the at least two vibratory motors when body motion is detected. In some embodiments of any of the aspects, the controller separately controls activation of i) at least one vibratory motor at the location of the assigned antagonist muscle position and ii) at least one vibratory motor at the location of the assigned agonist muscle position. In some embodiments of any of the aspects, the controller: classifies a detected body movement; assigns an agonist muscle position and antagonist muscle position for the classified detected body movement; andactivates at least one vibratory motor at the location of the assigned antagonist muscle position until the body movement slows below a threshold speed or the body movement a) slows below a threshold speed, b) changes direction or c) exhibits acceleration within certain bounds. In some embodiments of any of the aspects, the controller: classifies a detected body movement; assigns an agonist muscle position and antagonist muscleposition for the classified detected body movement; activates at least one vibratory motor at the location of the assigned antagonist muscle position until the body movement changes direction or acceleration; and / or activates at least one vibratory motor at the location of the assigned agonist muscle position until the body movement slows below a threshold speed.BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Fig. 1 depicts an image of an exemplary device.

[0024] Fig. 2 depicts a schematic of an exemplary device.

[0025] Fig. 3 depicts a schematic of controller workflow.

[0026] Fig. 4 depicts a schematic of an exemplary device.

[0027] Fig. 5 depicts a schematic of an exemplary system.DETAILED DESCRIPTION

[0028] As described herein, the inventors have found that vibrations applied during a spasm, e.g, during initiation of the spasm, can interrupt the spasm process, signalling to the agonist muscle that it should relax, thereby ending the spasm. Provided herein are devices, systems, and methods that can detect a spasm and apply the appropriate vibration to treat spasticity.

[0029] In one aspect of any of the embodiments, described herein is a system or device comprising: a) at least two vibratory motors; b) at least one gyroscope; and c) at least one accelerometer.

[0030] Exemplary embodiments are depicted in Figs. 4 and 5. For example, Fig. 4 depicts an exemplary device 100 comprising two vibratory motors 101, a gyroscope 110, an accelerometer 120, a controller 130, and a power source 140, and a body attachment means 150. The two vibratory motors 101, the gyroscope 110, the accelerometer 120, the controller 130, and the power source 140 are enclosed in the body attachment means 150, that takes the form of a strap or band that can be wrapped around a limb or body portion. The two vibratory motors 101 are spaced so that one is placed at a agonist muscle and the other is placed at an antagonist muscle.

[0031] As another example, Fig. 5 depicts an exemplary system 200 comprising two vibratory motors 101, a gyroscope 110, an accelerometer 120, a controller 130, a power source 140, and a body attachment means 150. The two vibratory motors 101, the gyroscope 110, the accelerometer 120, and the power source 140 are enclosed in the body attachment means 150, that takes the form of a strap or band that can be wrapped around a limb or body portion. The two vibratory motors 101 are spaced so that one is placed at a agonist muscle and the other is placed at an antagonist muscle. The controller 130 is a separate physical component, e.g., a computer or hand-held device, not attached to or nor enclosed by the body attachment means 150, and which is wirelessly connected to the two vibratory motors 101, the gyroscope 110, and the accelerometer 120.

[0032] In some embodiments of any of the aspects, the device 100 comprises at least two vibratory motors 101, a gyroscope 110, an accelerometer 120, a controller 130, and a power source 140, and a body attachment means 150. In some embodiments of any of the aspects, the system 200 comprises at least two vibratory motors 101, a gyroscope 110, an accelerometer 120, a controller 130, and a power source 140, and a body attachment means 150. In some embodiments of any of the aspects, the at least two vibratory motors 101, the gyroscope 110, the accelerometer 120, the controller 130, and the power source 140 are enclosed in the body attachment means 150. In some embodiments of any of the aspects, the at least two two vibratory motors 101 are spaced so that one is placed at an agonist muscle and the other is placed at an antagonist muscle. In some embodiments of any of the aspects, the at least two vibratory motors 101 are connected to the controller 130 and the power source 140 by a wire(s). In some embodiments of any of the aspects, the gyroscope 110 and the accelerometer 120 are connected to the controller 130 and the power source 140 by a wire(s). In some embodiments of any of the aspects, the controller 130 is connected to the power source 140 by a wire(s). In some embodiments of any of the aspects, the at least two two vibratory motors 101 are spaced so that one is placed at an agonist muscle and the other is placed at an antagonist muscle.

[0033] In some embodiments of any of the aspects, the device 100 comprises at least two vibratory motors 101, a gyroscope 110, an accelerometer 120, a controller 130, and a power source 140, and a body attachment means 150. In some embodiments of any of the aspects, the system 200 comprises at least two vibratory motors 101, a gyroscope 110, an accelerometer 120, a controller 130, and a power source 140, and a body attachment means 150. In some embodiments of any of the aspects, the at least two vibratory motors 101, the gyroscope 110, the accelerometer 120, the controller 130, and the power source 140 are enclosed in the body attachment means 150. In some embodiments of any of the aspects, the at least two two vibratory motors 101 are spaced so that one is placed at an agonist muscle and the other is placed at an antagonist muscle. In some embodiments of any of the aspects, the at least two vibratory motors 101 are connected to the controller 130 wirelessly. In some embodiments of any of the aspects, the at least two vibratory motors 101 are connected to the the power source 140 by a wire(s). In some embodiments of any of the aspects, the gyroscope 110 and the accelerometer 120 are connected to the controller 130 wirelessly. In some embodiments of any of the aspects, the gyroscope 110 and the accelerometer 120 are connected to the power source 140 by a wire(s). In some embodiments of any of the aspects, the controller 130 is connected to the power source 140 by a wire(s). In some embodiments of any of the aspects, the at least two two vibratory motors 101 are spaced so that one is placed at an agonist muscle and the other is placed at an antagonist muscle.

[0034] As used herein, “vibratory motor” refers to a device that can generate vibration and transmit that vibration to surrounding objects. In some embodiments, vibration motors can include “haptic motors.” Exemplary vibration motors 101 include but are not limited to vibrating disk motors,eccentric wheel vibration motors, eccentric rotating mass motors (e.g., coreless, iron core, or brushless), piezo vibration motors, solenoid vibration motors, linear resonant actuators, leaded vibration motors, through hole PCB vibration motors, SMD reflow vibration motors, coin and pancake vibration motors, and encapsulated vibration motors.

[0035] In some embodiments of any of the aspects, the at least two vibratory motors 101 are each configured to provide vibration in the range of 60-100 Hz. In some embodiments of any of the aspects, the at least two vibratory motors 101 are each configured to provide vibration in the range of 10-200 Hz. In some embodiments of any of the aspects, the at least two vibratory motors 101 are each configured to provide vibration in the range of 30-150 Hz.

[0036] In some embodiments of any of the aspects, the device / system comprises at least two vibratory motors 101 and the at least two vibratory motors are spaced non-contiguously. In some embodiments of any of the aspects, the device / system comprises at least two vibratory motors 101 and the at least two vibratory motors are spaced such that each applies vibration to a different muscle. This distance will vary upon the two muscles to be targeted, but is easily determined by detecting whether an arraignment of two vibratory motors 101 permits each vibratory motor 101 to activate the same muscle. In some embodiments of any of the aspects, the device / system comprises at least two vibratory motors 101 and the at least two vibratory motors are spaced such that each each is located superficial to a different muscle when the device 100 and / or body attachment means 150 is placed on a subject. Being located superficial to a muscle refers to a position along an axis from the skin, through the muscle, to the center of the limb or body part; which is closer to the skin surface than the muscle.

[0037] In some embodiments of any of the aspects, the at least one gyroscope 110 and at least one accelerometer 120 (e.g., a two-axis accelerometer, a three-axis accelerometer) form an inertial measurement unit (IMU) in that they provide data that is used for sensing or detecting motion, e.g., body motion. The data provided by the IMU can be utilized in to detect the orientation and position of the device / system (or the body or limb is it attached to) in three-dimensional space over time. The gyroscope 110 can also provide data regarding angular velocity, which can be used to determine the angular acceleration (and rotational force) of the device / system (or the body or limb is is attached to). A gyroscope 110 and an accelerometer 120 can be provided as a single IMU unit. A gyroscope 110 and an accelerometer 120 can be provided as two separate components, such that they are not packaged together.

[0038] In some embodiments of any of the aspects, the at least one gyroscope 110 and at least one accelerometer 120 are configured to detect movement of the body. In some embodiments of any of the aspects, the at least one gyroscope 110 is configured to detect movement of the body. In some embodiments of any of the aspects, the at least one accelerometer 120 is configured to detect movement of the body.

[0039] In some embodiments of any of the aspects, the system or device comprises: a) two vibratory motors 101; b) at least one gyroscope 110; and c) at least one accelerometer 120. In some embodiments of any of the aspects, the system or device comprises: a) three vibratory motors 101; b) at least one gyroscope 110; and c) at least one accelerometer 120. In some embodiments of any of the aspects, the system or device comprises: a) four vibratory motors 101; b) at least one gyroscope 110; and c) at least one accelerometer 120. In some embodiments of any of the aspects, the system or device comprises: a) five vibratory motors 101; b) at least one gyroscope 110; and c) at least one accelerometer 120. In some embodiments of any of the aspects, the system or device comprises: a) six vibratory motors 101; b) at least one gyroscope 110; and c) at least one accelerometer 120.

[0040] In some embodiments of any of the aspects, the system or device comprises: a) at least two vibratory motors 101; b) a gyroscope 110; and c) an accelerometer 120. In some embodiments of any of the aspects, the system or device comprises: a) at least two vibratory motors 101; b) two gyroscopes 110; and c) an accelerometer 120. In some embodiments of any of the aspects, the system or device comprises: a) at least two vibratory motors 101; b) a gyroscope 110; and c) two accelerometers 120. In some embodiments of any of the aspects, the system or device comprises: a) at least two vibratory motors 101; b) two gyroscopes 110; and c) two accelerometers 120.

[0041] In some embodiments of any of the aspects, the system or device comprises: a) at least two vibratory motors 101; b) a plurality of gyroscopes 110; and c) an accelerometer 120. In some embodiments of any of the aspects, the system or device comprises: a) at least two vibratory motors 101; b) a gyroscope 110; and c) a plurality of accelerometers 120. In some embodiments of any of the aspects, the system or device comprises: a) at least two vibratory motors 101; b) a plurality of gyroscopes 110; and c) a plurality of accelerometers 120.

[0042] In some embodiments of any of the aspects, the system or device further comprises at least one of: at least one controller 130; at least one power source 140; and at least one body attachment means 150. In some embodiments of any of the aspects, the system or device further comprises: at least one controller 130; at least one power source 140; and at least one body attachment means 150. In some embodiments of any of the aspects, the system or device further comprises: at least one controller 130 and at least one power source 140. In some embodiments of any of the aspects, the system or device further comprises: at least one controller 130 and at least one body attachment means 150. In some embodiments of any of the aspects, the system or device further comprises at least one power source 140 and at least one body attachment means 150.

[0043] In some embodiments of any of the aspects, the system or device further comprises at least one controller 130. As used herein, “controller” or computing device refers to a non-human apparatus that is capable of accepting a structured input, processing the structured input according to prescribed rules, and producing results of the processing as output. The controller 130 can include any suitable processing device, such as general purpose computer systems, microprocessors, digital signalprocessors, micro-controllers, application specific integrated circuits (ASICs), programmable logic devices (PLDs) field programmable logic devices (FPLDs), programmable gate arrays (PGAs), field programmable gate arrays (FPGAs), mobile devices such as mobile telephones, personal digital assistants (PDAs), or tablet computers, local servers, remote servers, wearable computers, or the like. In some embodiments, the controller 130 can comprise or be connected to (or in communication with) a memory device. The memory device can include any suitable memory device and / or machine- readable medium that is capable of storing, encoding, and / or carrying a set of instructions for execution by a processing device and that cause the processing device to perform and / or implement any of the features discussed herein, including solid-state memories, optical media, magnetic media, random access memory (RAM), read only memory (ROM), a floppy disk, a hard disk, a CD ROM, a DVD ROM, flash memory, or other computer readable medium that is read from and / or written to by a magnetic, optical, or other reading and / or writing system that is coupled to the processing device, can be used for the memory or memories.

[0044] In some embodiments of any of the aspects, the system comprises a computing device, a server, a network, and / or a database. As a non-limiting example, data output from the at least one accelerometer 120 and / or at least one gyroscope 110 as described herein can be displayed on a computing device and / or input into a program that can be stored in a database. In some embodiments, the data is wirelessly transmitted from the at least one accelerometer 120 and / or at least one gyroscope 110 to a controller 130 or computing device, such as but not limited to a mobile phone. In some embodiments, the computing device and server can be connected by a network and the network can be connected to various other devices, servers, or network equipment for implementing the present disclosure. A computing device can be connected to a display. Computing device can be any suitable computing device, including a desktop computer, server (including remote servers), mobile device, or other suitable computing device. In some examples, algorithm(s) as described herein and other software can be stored in database and run on server. Additionally, data and data processed or produced by said algorithms or programs can be stored in a database.

[0045] It should be understood that the disclosure herein can be implemented with any type of hardware and / or software and can be a pre-programmed general purpose computing device. For example, the system can be implemented using a server, a personal computer, a portable computer, a thin client, or any suitable device or devices. The disclosure and / or components thereof can be a single device at a single location, or multiple devices at a single, or multiple, locations that are connected together using any appropriate communication protocols over any communication medium such as electric cable, fiber optic cable, or in a wireless manner.

[0046] It should also be noted that the disclosure can be illustrated and discussed herein as having a plurality of modules which perform particular functions. It should be understood that these modules are merely schematically illustrated based on their function for clarity purposes only, and donot necessary represent specific hardware or software. In this regard, these modules can be hardware and / or software implemented to substantially perform the particular functions discussed. Moreover, the modules can be combined together within the disclosure or divided into additional modules based on the particular function desired. Thus, the disclosure should not be construed to limit the present technology as disclosed herein, but merely be understood to illustrate one exemplary implementation thereof.

[0047] The computing system can include clients and servers. A client and server are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other. In some implementations, a server transmits data (e.g., an HTML page) to a client device (e.g., for purposes of displaying data to and receiving user input from a user interacting with the client device). Data generated at the client device (e.g., a result of the user interaction) can be received from the client device at the server. Implementations of the subject matter described herein can be implemented in a computing system that includes a back end component, e.g., as a data server, or that includes a middleware component, e.g., an application server, and / or that includes a front end component, e.g., a client computer having a graphical user interface or a Web browser through which a user can interact with an implementation of the subject matter described in this specification, or any combination of one or more such back end, middleware, or front end components. The components of the system can be interconnected by any form or medium of digital data communication, e.g., a communication network. Examples of communication networks include a local area network (“LAN”) and a wide area network (“WAN”), an inter-network (e.g., the Internet), and peer-to-peer networks (e.g., ad hoc peer to-peer networks).

[0048] Implementations of the subject matter and the operations described herein can be implemented in digital electronic circuitry, or in computer software, firmware, or hardware, including the structures disclosed herein and their structural equivalents, or in combinations of one or more of them. Implementations of the subject matter described herein can be implemented as one or more computer programs, e.g., one or more modules of computer program instructions, encoded on computer storage medium for execution by, or to control the operation of, data processing apparatus. Alternatively or in addition, the program instructions can be encoded on an artificially generated propagated signal, e.g., a machine -generated electrical, optical, or electromagnetic signal that is generated to encode information for transmission to suitable receiver apparatus for execution by a data processing apparatus. A computer storage medium can be, or be included in, a computer-readable storage device, a computer-readable storage substrate, a random or serial access memory array or device, or a combination of one or more of them. Moreover, while a computer storage medium is not a propagated signal, a computer storage medium can be a source or destination of computer program instructions encoded in an artificially generated propagated signal. The computer storage medium canalso be, or be included in, one or more separate physical components or media (e.g., multiple CDs, disks, or other storage devices).

[0049] The operations described in this specification can be implemented as operations performed by a “data processing apparatus” on data stored on one or more computer-readable storage devices or received from other sources. The term “data processing apparatus” encompasses all kinds of apparatus, devices, and machines for processing data, including by way of example a programmable processor, a computer, a system on a chip, or multiple ones, or combinations, of the foregoing. The apparatus can include special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application specific integrated circuit). The apparatus can also include, in addition to hardware, code that creates an execution environment for the computer program in question, e.g., code that constitutes processor firmware, a protocol stack, a database management system, an operating system, a cross-platform runtime environment, a virtual machine, or a combination of one or more of them. The apparatus and execution environment can realize various different computing model infrastructures, such as web services, distributed computing, and grid computing infrastructures.

[0050] A computer program (also known as a program, software, software application, script, or code) can be written in any form of programming language, including compiled or interpreted languages, declarative or procedural languages, and it can be deployed in any form, including as a standalone program or as a module, component, subroutine, object, or other unit suitable for use in a computing environment. A computer program can, but need not, correspond to a file in a file system. A program can be stored in a portion of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files that store one or more modules, sub programs, or portions of code). A computer program can be deployed to be executed on one computer or on multiple computers that are located at one site or distributed across multiple sites and interconnected by a communication network.

[0051] The processes and logic flows described in this specification can be performed by one or more programmable processors executing one or more computer programs to perform actions by operating on input data and generating output. The processes and logic flows can also be performed by, and apparatus can also be implemented as, special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application specific integrated circuit).

[0052] Processors suitable for the execution of a computer program include, by way of example, both general and special purpose microprocessors, and any one or more processors of any kind of digital computer. Generally, a processor can receive instructions and data from a read only memory or a random access memory or both. The essential elements of a computer are a processor for performing actions in accordance with instructions and one or more memory devices for storing instructions anddata. Generally, a computer will also include, or be operatively coupled to receive data from or transfer data to, or both, one or more mass storage devices for storing data, e.g., magnetic, magneto optical disks, or optical disks. However, a computer need not have such devices. Moreover, a computer can be embedded in another device, e.g., a mobile telephone, a personal digital assistant (PDA), a mobile audio or video player, a game console, a Global Positioning System (GPS) receiver, or a portable storage device (e.g., a universal serial bus (USB) flash drive), to name just a few. Devices suitable for storing computer program instructions and data include all forms of nonvolatile memory, media and memory devices, including by way of example semiconductor memory devices, e.g., EPROM, EEPROM, and flash memory devices; magnetic disks, e.g., internal hard disks or removable disks; magneto optical disks; and CD ROM and DVD-ROM disks. The processor and the memory can be supplemented by, or incorporated in, special purpose logic circuitry.

[0053] In some embodiments of any of the aspects, the controller 130 is configured to activate at least one of the at least two vibratory motors 101 when body motion is detected. In some embodiments of any of the aspects, the controller 130 is configured to activate at least one of the at least two vibratory motors 101 when motion of the limb is detected. In some embodiments of any of the aspects, the controller 130 is configured to activate at least one of the at least two vibratory motors 101 when motion of a first joint is detected. In some embodiments of any of the aspects, the controller 130 is configured to activate at least one of the at least two vibratory motors 101 when motion of a second joint detected.

[0054] In some embodiments of any of the aspects, the controller 130 is configured to activate less than all of the at least two vibratory motors 101 when body motion is detected. In some embodiments of any of the aspects, the controller 130 is configured to activate less than all of the at least two vibratory motors 101 when motion of the limb is detected. In some embodiments of any of the aspects, the controller 130 is configured to activate less than all of the at least two vibratory motors 101 when motion of the first joint is detected. In some embodiments of any of the aspects, the controller 130 is configured to activate less than all of the at least two vibratory motors 101 when motion of the second joint is detected.

[0055] In some embodiments of any of the aspects, the controller 130 is configured to separately control activation of each of the at least two vibratory motors 101 when body motion is detected. In some embodiments of any of the aspects, the controller 130 is configured to separately control activation of each of the at least two vibratory motors 101 when motion of the limb is detected. In some embodiments of any of the aspects, the controller 130 is configured to separately control activation of each of the at least two vibratory motors 101 when motion of the first joint is detected. In some embodiments of any of the aspects, the controller 130 is configured to separately control activation of each of the at least two vibratory motors 101 when motion of the second joint is detected.

[0056] In some embodiments of any of the aspects, the controller 130 is configured to: classify a detected movement (e.g., body movement, limb movement, joint movement); assign an agonist muscle position and antagonist muscle position for the classified detected body movement; and activate at least one vibratory motor 101 at the location of the assigned antagonist muscle position. Classification can comprise detecting the direction, vector, speed, acceleration, and / or magnitude of a movement. Classicification can comprise determining the joints and / or muscles involved in a movement. Classification can comprise determining which muscles must contract and / or relax to accomplish the movement. Classification can comprise determining which muscles must contract and / or relax to accomplish the full scope of a movement. Classification can comprise comparing the direction, vector, speed, acceleration, and / or magnitude of a movement to a database of such movement characteristics and the corresponding agonist muscle positions and antagonist muscle positions.

[0057] In some embodiments of any of the aspects, the controller 130 is configured to: classify a detected body movement; assign an agonist muscle position and / or antagonist muscle position for the classified detected body movement; and activate at least one vibratory motor 101 at the location of the assigned antagonist muscle position until the body movement a) slows below a threshold speed, b) changes direction or c) exhibits acceleration within certain bounds.

[0058] In some embodiemnts of any of the aspects, the controller 130 is configured to: classify a detected body movement; assign an agonist muscle position and antagonist muscle position for the classified detected body movement; and activate at least one vibratory motor 101 at the location of the assigned antagonist muscle position until the body movement changes direction or acceleration; active at least one vibratory motor 101 at the location of the assigned agonist muscle position until the body movement slows below a threshold speed.

[0059] In some embodiments of any of the aspects, the controller 130 is configured to separately control activation of i) at least one vibratory motor 101 at the location of the assigned antagonist muscle position and ii) at least one vibratory motor 101 at the location of the assigned agonist muscle position. In some embodiments of any of the aspects, the system or device comprises one controller 130. In some embodiments of any of the aspects, the system or device comprises one controller 130 for each vibratory motor 101. In some embodiments of any of the aspects, the controller 130 is located in or on the body attachment means 150. In some embodiments of any of the aspects, the controller 130 is connected by a wire or cord to the vibratory motor(s) 101, accelerometer 120, and / or gyroscope 110, wherein the vibratory motor(s) 101, accelerometer 120, and gyroscope are located in or on the body attachment means 150. In some embodiments of any of the aspects, the controller 130 is located external to the body attachment means 150. In some embodiments of any of the aspects, the controller 130 is wirelessly connected to the vibratory motor(s) 101, accelerometer 120, and / orgyroscope 110, wherein the vibratory motor(s) 101, accelerometer 120, and gyroscope 110 are located in or on the body attachment means 150.

[0060] In some embodiments of any of the aspects, the system or device further comprises at least one power source 140. In some embodiments of any of the aspects, the power source 140 can be or comprise a battery, e.g., a battery in the device / system. The battery can store electrical energy and supply it to the vibratory motor(s) 101, accelerometer 120, gyroscope 110, and / or controller 130. In some embodiments of any of the aspects, the power source 140 can comprise a cord or other means of connection to an electrical power source, such as electrical outlet. The power source 140 can be connected in a wired or wireless manner.

[0061] In some embodiments of any of the aspects, the system or device comprises one power source 140. In some embodiments of any of the aspects, the system or device comprises one power source 140 for each vibratory motor 101. In some embodiments of any of the aspects, the power source 140 is located in or on the body attachment means 150. In some embodiments of any of the aspects, the power source 140 is connected by a wire or cord to the vibratory motor(s) 101, accelerometer 120, and / or gyroscope 110, wherein the vibratory motor(s) 101, accelerometer 120, and gyroscope are located in or on the body attachment means 150. In some embodiments of any of the aspects, the power source 140 is located external to the body attachment means 150. In some embodiments of any of the aspects, the power source 140 is wirelessly connected to the vibratory motor(s) 101, accelerometer 120, and / or gyroscope 110, wherein the vibratory motor(s) 101, accelerometer 120, and gyroscope 110 are located in or on the body attachment means 150.

[0062] In some embodiments of any of the aspects, the controller 130 and / or power source 140 in communication with one or more of the at least two vibratory motors 101, at least one gyroscope 110, and at least one accelerometer 120. In some embodiments of any of the aspects, the controller 130 and / or power source 140 are physically connected to or connectable with one or more of the at least two vibratory motors 101, at least one gyroscope 110, and at least one accelerometer 120. In some embodiments of any of the aspects, the controller 130 and / or power source 140 are wirelessly connected to or connectable with one or more of the at least two vibratory motors 101, at least one gyroscope 110, and at least one accelerometer 120.

[0063] In some embodiments of any of the aspects, the power source 140 comprises a battery, a cord, and / or a wireless power source. In some embodiments of any of the aspects, the power source 140 comprises a battery. In some embodiments of any of the aspects, the power source 140 comprises a cord. In some embodiments of any of the aspects, the power source 140 comprises a wireless power source.

[0001] In some embodiments of any of the aspects, the system or device further comprises at least one body attachment means 150. As used herein, “body attachment means” or “body attachment device” refers to a means or device that permits attachment to the body of a subject. Exemplary bodyattachment means / devices 150 can include but are not limited to wraps, straps, braces, collars, adhesives, splints, belts, compression wraps, sleeves, gloves, socks, pads, bandages, bracelets, elastomeric wraps, and the like.

[0064] In some embodiments of any of the aspects, the at least one body attachment means 150 comprises a wrap or strap. In some embodiments of any of the aspects, the at least one body attachment means 150 is a wrap or strap. In some embodiments of any of the aspects, the at least one body attachment means 150 comprises a magnetic closure. In some embodiments of any of the aspects, the at least one body attachment means 150 comprises an adhesive surface.

[0065] In some embodiments of any of the aspects, the at least one body attachment means 150 comprises a wrap or strap that fully encircles a limb. In some embodiments of any of the aspects, the at least one body attachment means 150 is a wrap or strap that fully encircles a limb.

[0066] In some embodiments of any of the aspects, the at least one body attachment means 150 comprises a wrap or strap that fully encircles a limb above a joint. In some embodiments of any of the aspects, the at least one body attachment means 150 is a wrap or strap that fully encircles a limb above a joint.

[0067] In some embodiments of any of the aspects, the joint is a wrist, an ankle, an elbow, or a knee. In some embodiments of any of the aspects, the joint is a wrist. In some embodiments of any of the aspects, the joint is an ankle. In some embodiments of any of the aspects, the joint is an elbow. In some embodiments of any of the aspects, the joint is a knee.

[0068] In some embodiments of any of the aspects, the at least one body attachment means 150 comprises a wrap or strap that fully encircles a part of a body. In some embodiments of any of the aspects, the at least one body attachment means 150 is a wrap or strap that fully encircles a part of a body. In some embodiments of any of the aspects, the part of the body is the thoracic cavity, abdomen, back, or cervical region. In some embodiments of any of the aspects, the part of the body is the thoracic cavity. In some embodiments of any of the aspects, the part of the body is the abdomen. In some embodiments of any of the aspects, the part of the body is the back. In some embodiments of any of the aspects, the part of the body is the cervical region.

[0069] In some embodiments of any of the aspects, the limb is a human limb. In some embodiments of any of the aspects, the joint is a human joint. In some embodiments of any of the aspects, the body is a human body. In some embodiments of any of the aspects, the limb is an adult human limb. In some embodiments of any of the aspects, the joint is an adult human joint. In some embodiments of any of the aspects, the body is an adult human body.

[0070] In some embodiments of any of the aspects, the device or system comprises one body attachment means 150. In some embodiments of any of the aspects, the device or system comprises two body attachment means 150. In some embodiments of any of the aspects, the device or system comprises a plurality of body attachment means 150.

[0071] In some embodiments of any of the aspects, the at least two vibratory motors 101 are attached to or enclosed by at least one body attachment means 150. In some embodiments of any of the aspects, the at least two vibratory motors 101 are attached to at least one body attachment means 150. In some embodiments of any of the aspects, the at least two vibratory motors 101 are enclosed by at least one body attachment means 150.

[0072] In some embodiments of any of the aspects, the at least two vibratory motors 101 are attached to or enclosed by the same body attachment means 150. In some embodiments of any of the aspects, the at least two vibratory motors 101 are attached to the same body attachment means 150. In some embodiments of any of the aspects, the at least two vibratory motors 101 are enclosed by the same body attachment means 150.

[0073] In some embodiments of any of the aspects, the at least two vibratory motors 101 are each attached to or enclosed by a body attachment means 150. In some embodiments of any of the aspects, the at least two vibratory motors 101 are each attached to a body attachment means 150. In some embodiments of any of the aspects, the at least two vibratory motors 101 are each enclosed by a body attachment means 150.

[0074] When an element is attached to or enclosed by a body attachment means 150, the element can be permanently attached / enclosed (e.g., sew-in, glued, or fused), or temporarily attached / enclosed (e.g., by magnets, velcros, snaps, or the like). The attachment or enclosure secures the element at a specific point in / on the body attachment means 150 during operation of the vibratory motor 101 and normal movement of a body. The attachment or enclosure should permit vibrations to transmit from the vibratory motor 101 into a body tissue in contact with the body attachment means 150. Such attachments / enclosures are known in the art and readily achieved by the use of, e.g., suitable fabrics or padding materials between a vibratory motor 101 and the surface of a body attachment means 150 that will be in contact with a body.

[0075] In some embodiments of any of the aspects, the at least two vibratory motors 101 are attached to or enclosed by a first body attachment means 150 such that a first vibratory motor 101 is be positioned at the location of a tendon of the first muscle of a set of agonist-antagonist muscles and a second vibratory motor 101 is positioned at the location of a tendon of a second muscle of the set of agonist-antagonist muscles. In some embodiments of any of the aspects, the at least two vibratory motors 101 are attached to a first body attachment means 150 such that a first vibratory motor 101 can be positioned at the location of a tendon of the first muscle of a set of agonist-antagonist muscles and a second vibratory motor 101 can positioned at the location of a tendon of a second muscle of the set of agonist-antagonist muscles. In some embodiments of any of the aspects, the at least two vibratory motors 101 are enclosed by a first body attachment means 150 such that a first vibratory motor 101 can be positioned at the location of a tendon of the first muscle of a set of agonist-antagonist muscles and a second vibratory motor 101 can positioned at the location of a tendon of a second muscle of theset of agonist-antagonist muscles. Such embodiments can place the at least two vibratory motors 101 at fixed positions in the system / device (e.g., distances from each other) such that the desired placement on the tendons is possible. Such embodiments can place the at least two vibratory motors lOlat fixed positions in the system / device (e.g., distances from each other), and shaping or molding in the body attachment mean(s) 150, such that the desired placement on the tendons is possible. Such embodiments can place the at least two vibratory motors 101 at fixed positions in the system / device (e.g., distances from each other), and shaping or molding in the body attachment mean(s) 150, such that the desired placement on the tendons is directed. Such embodiments can place the at least two vibratory motors 101 at fixed positions in the system / device (e.g., distances from each other), and shaping or molding in the body attachment mean(s) 150, such that the desired placement on the tendons is necessary in order to secure the body attachment means 150.

[0076] In some embodiments of any of the aspects, a first body attachment means 150 is provided markings to index the first body attachment means 150 to a specific position on a body; and the at least two vibratory motors 101 are non-movably attached to or are enclosed by the first body attachment means 150 such that, when the body attachment means 150 is indexed to the body, a first vibratory motor 101 is positioned at the location of a tendon of an agonist muscle and a second vibratory motor 101 can positioned at the location of a tendon of a corresponding antagonist muscle. Indexing refers to placing a body attachment means 150, or a specific point on a body attachment means 150, in a specific position on a body, relative to some aspect of a body. This permits proper placement of the device / system such that vibratory motor(s) 101 are in close proximity to the desired tendons / muscles. Such markings can include words, figures, symbols, arrows, shaping of the body attachment means 150, or the like. The markings can direct the proper indexing, e.g., as a shape that requires a thumb or kneecap to be inserted in a hole in the body attachment means 150, or the markings can permit proper indexing in conjunction with written instructions, e.g., an arrow that written instructions direct is to be aligned with the web between two digits.

[0077] As used herein, “non-movably” refers to an attachment or enclosure able to retain a vibratory motor 101 in position while the vibratory motor 101 operates and a body is in normal movement. A non-movable attachment / enclosure can be temporary or permenant. A temporary nonmovable attachment / enclosure can be disrupted or adjusted by other intervention, e.g., additional force or manipulation of the attachment / enclosure means. Temporary attachment / enclosure means are discussed elsewhere herein.

[0078] In some embodiments of any of the aspects, a first body attachment means 150 is formed to fit and attach to a body in only one position; and the at least two vibratory motors 101 are non- movably attached to or enclosed by the first body attachment means 150 such that, when the body attachment means 150 is attached to the body, a first vibratory motor 101 is positioned at the locationof a tendon of an agonist muscle and a second vibratory motor 101 is positioned at the location of a tendon of a corresponding antagonist muscle.

[0079] In some embodiments of any of the aspects, the at least two vibratory motors 101 are attached to or enclosed by a first body attachment means 150; and the first body attachment means 150 comprises a rigid portion at the location of each of the at least two vibratory motors 101, wherein the rigid portion is or is configured to be more distal from the body than the at least two vibratory motors 101. A rigid portion can comprise plastic or metal.

[0080] In some embodiments of any of the aspects, the at least two vibratory motors 101 are implanted or injected in a subject. In some embodiments of any of the aspects, the at least two vibratory motors 101 are implanted in a subject. In some embodiments of any of the aspects, the at least two vibratory motors 101 are injected in a subject.

[0081] In some embodiments of any of the aspects, the device or system comprises one body attachment means 150, the body attachment means 150 comprising at least: a) at least two vibratory motors 101; b) at least one gyroscope 110; and c) at least one accelerometer 120.

[0082] In some embodiments of any of the aspects, the device or system comprises one body attachment means 150, the body attachment means 150 enclosing at least: a) at least two vibratory motors 101; b) at least one gyroscope 110; and c) at least one accelerometer 120.

[0083] In some embodiments of any of the aspects, the device or system comprises one body attachment means 150, the body attachment means 150 attached to at least: a) at least two vibratory motors 101; b) at least one gyroscope 110; and c) at least one accelerometer 120.

[0084] In some embodiments of any of the aspects, the device or system comprises two or more body attachment means 150, each body attachment means 150 comprising at least: a) at least two vibratory motors 101; b) at least one gyroscope 110; and c) at least one accelerometer 120.

[0085] In some embodiments of any of the aspects, the device or system comprises two or more body attachment means 150, each body attachment means 150 enclosing at least: a) at least two vibratory motors 101; b) at least one gyroscope 110; and c) at least one accelerometer 120.

[0086] In some embodiments of any of the aspects, the device or system comprises two or more body attachment means 150, each body attachment means 150 attached to at least: a) at least two vibratory motors 101; b) at least one gyroscope 110; and c) at least one accelerometer 120.

[0087] In some embodiments of any of the aspects, the at least two vibratory motors 101, at least one gyroscope 110, and at least one accelerometer 120 of the / each body attachment means 150 is in communication with and / or controllable by a single controller 130.

[0088] In some embodiments of any of the aspects, a first body attachment means 150 is configured or placed above a first joint of a limb and a second body attachment means 150 is configured or placed above a second joint of the limb. In some embodiments of any of the aspects, a first body attachment means 150 is configured or placed proximal a first joint of a limb and a second body attachment means 150 is configured or placed distal of the first joint of the limb.

[0089] In some embodiments of any of the aspects, the system or device comprises a first body attachment means 150 configured or placed to extend from above a first joint of a limb to above a second joint of the limb; wherein the first body attachment means 150 comprises at least two vibratory motors 101, at least one gyroscope 110, and at least one accelerometerl20 above the first joint of the limb and at least two vibratory motors 101, at least one gyroscope 110, and at least one accelerometer 120above the second joint of the limb.

[0090] In some embodiments of any of the aspects, the first joint is a wrist and the second joint is an elbow, or the first joint is an ankle and the second joint is a knee. In some embodiments of any of the aspects, the first joint is a wrist and the second joint is an elbow. In some embodiments of any of the aspects, the first joint is an ankle and the second joint is a knee. In some embodiments of any of the aspects, the first joint is the wrist. In some embodiments of any of the aspects, the first joint is the elbow. In some embodiments of any of the aspects, the first joint is the ankle. In some embodiments of any of the aspects, the first joint is the knee. In some embodiments of any of the aspects, the first joint is the hip. In some embodiments of any of the aspects, the first joint is the shoulder.

[0091] As used herein, above a joint refers to a proximal position and below a joint refers to a distal position.

[0092] In some embodiments of any of the aspects, a portion of the at least two vibratory motors 101 which is or is configured to be most distal from the body is rigid. In some embodiments of any of the aspects, a portion of the body attachment means 150 in contact with the vibratory motor 101 which is or is configured to be most distal from the body is rigid.

[0093] In some embodiments of any of the aspects, the device or system comprises only two vibratory motors 101. In some embodiments of any of the aspects, each body attachment means 150 comprises only two vibratory motors 101. In some embodiments of any of the aspects, each bodyattachment means 150 encloses only two vibratory motors 101. In some embodiments of any of the aspects, each body attachment means 150 is attached to only two vibratory motors 101.

[0094] In some embodiments of any of the aspects, the system or device further comprises at least one of a receiver, antenna, and / or transmitter. In some embodiments of any of the aspects, the system or device further comprises a receiver. In some embodiments of any of the aspects, the system or device further comprises an antenna. In some embodiments of any of the aspects, the system or device further comprises a transmitter.

[0095] In one aspect of any of the embodiments, described herein is a method of treating spasticity in a subject in need thereof, the method comprising; placing at least one body attachment means 150 of a device or system described herein on the subject, or injecting or implanting the at least two vibration motors in the subject; whereby the at least one accelerometer 120 and / or at least one gyroscope 110 of the system detects body movement of the subject; the controller 130 classifies the detected body movement and assigns an agonist muscle position and / or antagonist muscle position for the classified detected body movement; and the controller 130 activates at least one vibratory motor 101 at the location of the assigned antagonist or agonist muscle position.

[0096] As used herein, “spasticity” refers to a disorder, disease, condition, or symptom where muscles tighten or stiffen, thereby impairing normal movemen or use of the muscles. The tightness or stiffness can cause spasms. The tightness or stiffness can be continuous. The tightness or stiffness can cause exaggerated reflexes. The tightness or stiffness can cause unwanted or unintended movement. The tightness or stiffness can inhibit or prevent wanted or intentional movement.

[0097] In some embodiments, the methods described herein relate to treating a subject having or diagnosed as having spasticity with a device or system described herein. Subjects having spasticity can be identified by a physician using current methods of diagnosing spasticity. Symptoms and / or complications of spasticity which characterize these conditions and aid in diagnosis are well known in the art and include but are not limited to, hypertonia, spasms, clonus, pain, contracture, and sleep distruption. Tests that may aid in a diagnosis of, e.g. spasticity include, but are not limited to, physical examination and reflext testing. A family history of spasticity, or exposure to risk factors for spasticity (e.g. brain / spinal cord infection or injury) can also aid in determining if a subject is likely to have spasticity or in making a diagnosis of spasticity.

[0098] In some embodiemnts of any of the aspects, a subject in need of treatment for spasticity can be a patient having or diagnosed as having: brain damage, cerebral palsy, head injury, nervous system infections, multiple sclerosis, cervical spinal stenosis, a neurodegenerative illness, phenylketonuria, spinal cord injury, stroke, nervous system tumors, poisoning, or vitamin or mineral deficiency (e.g., vitamin B 12, vitamin E, copper).

[0099] The methods described herein can be administered to a subject having or diagnosed as having spasticity. In some embodiments, the methods described herein comprise administering aneffective amount of vibration from a vibratory motor 101 described herein, e.g. to a subject in order to alleviate a symptom of spasticity. As used herein, "alleviating a symptom" is ameliorating any condition or symptom associated with the spasticity. As compared with an equivalent untreated control, such reduction is by at least 5%, 10%, 20%, 40%, 50%, 60%, 80%, 90%, 95%, 99% or more as measured by any standard technique.

[0100] The term “effective amount" as used herein refers to the amount of vibration needed to alleviate at least one or more symptom of the disease or disorder, and relates to a sufficient amount of pharmacological composition to provide the desired effect. The term "therapeutically effective amount" therefore refers to an amount of vibration that is sufficient to provide a particular antispasticity effect when administered to atypical subject. An effective amount as used herein, in various contexts, would also include an amount sufficient to delay the development of a symptom of the disease, alter the course of a symptom disease (for example but not limited to, slowing the progression of a symptom of the disease), or reduce or reverse a symptom of the disease. Thus, it is not generally practicable to specify an exact “effective amount". However, for any given case, an appropriate “effective amount" can be determined by one of ordinary skill in the art using only routine experimentation.

[0101] Effective amounts of vibration (e.g., strength and duration), and therapeutic efficacy can be determined by standard medical procedures. For example, a particular vibration strength and duration can be administered and the severity and frequency of spasms, or control of muscles can be measured and compared to other amounts of vibration to select a minimum or optimal amount of vibration. The amount of vibration can also be varied, e.g., by the subject or a medical professional, using the controller 130 and in response to current effectiveness or severity of symptoms.

[0102] The amount of vibration as described herein can be determined by a physician and adjusted, as necessary, to suit observed effects of the treatment. With respect to duration and frequency of treatment, it is typical for skilled clinicians to monitor subjects in order to determine when the treatment is providing therapeutic benefit, and to determine whether to increase or decrease dosage, increase or decrease administration frequency, discontinue treatment, resume treatment, or make other alterations to the treatment regimen. The treatment schedule, or use of the device / system described herein, can vary from continuous, daily, or less frequenctly depending on a number of clinical factors, such as the subject's sensitivity to treatment, the severity of the spasticity, and the subject’s desired degree of muscle control.

[0103] The ranges for the amount of vibration, according to the methods described herein depend upon, for example, the form of the device / system, its potency, and the extent to which symptoms, markers, or indicators of a condition described herein are desired to be reduced, for example the percentage reduction desired for spasms or the extent to which, for example, voluntary muscle control is desired to be induced. The amount should not be so large as to cause adverse side effects, such aspain. Generally, the amount will vary with the age, condition, and sex of the patient and can be determined by one of skill in the art. The dosage can also be adjusted by the individual physician in the event of any complication.

[0104] The efficacy of a method described herein in, e.g. the treatment of a condition described herein, or to induce a response as described herein (e.g. less spasticity) can be determined by the skilled clinician. However, a treatment is considered “effective treatment," as the term is used herein, if one or more of the signs or symptoms of a condition described herein are altered in a beneficial manner, other clinically accepted symptoms are improved, or even ameliorated, or a desired response is induced e.g., by at least 10% following treatment according to the methods described herein. Efficacy can be assessed, for example, by measuring a marker, indicator, symptom, and / or the incidence of a condition treated according to the methods described herein or any other measurable parameter appropriate, e.g. spasm frequency or severity. Efficacy can also be measured by a failure of an individual to worsen as assessed by hospitalization, or need for medical interventions (i.e., progression of the disease is halted). Methods of measuring these indicators are known to those of skill in the art and / or are described herein. Treatment includes any treatment of a disease in an individual or an animal (some non-limiting examples include a human or an animal) and includes: (1) inhibiting the disease, e.g., preventing a worsening of symptoms (e.g. pain or inflammation); or (2) relieving the severity of the disease, e.g., causing regression of symptoms. An effective amount for the treatment of a disease means that amount which, when administered to a subject in need thereof, is sufficient to result in effective treatment as that term is defined herein, for that disease. Efficacy of an agent can be determined by assessing physical indicators of a condition or desired response, (e.g. reduction in spasm frequency or severity). It is well within the ability of one skilled in the art to monitor efficacy of administration and / or treatment by measuring any one of such parameters, or any combination of parameters.

[0105] In some embodiments of any of the aspects, the device or system described herein is administered as a monotherapy, e.g., another treatment for the spasticity is not administered to the subject.

[0106] In some embodiments of any of the aspects, the methods described herein can further comprise administering a second agent and / or treatment to the subject, e.g. as part of a combinatorial therapy. Non-limiting examples of a second agent and / or treatment can include botulinum toxin, baclofen, tizanidine, dantrolene sodium, diazepam, clonazepam, gabapentin, intrathecal baclofen therapy, and selective dorsal rhizotomy.

[0107] In one respect, the present invention relates to the herein described device, system, methods, and respective component(s) thereof, as essential to the technology, yet open to the inclusion of unspecified elements, essential or not ("comprising). In some embodiments of any of the aspects, other elements to be included in the description of the device, system, method or respectivecomponent thereof are limited to those that do not materially affect the basic and novel characteristic(s) of the technology (e.g., the composition, method, or respective component thereof “consists essentially of’ the elements described herein). This applies equally to steps within a described method as well as device, system, and components therein. In other embodiments of any of the aspects, the device, system, methods, and respective components thereof, described herein are intended to be exclusive of any element not deemed an essential element to the component, device, system, or method (e.g., the device, system, method, or respective component thereof “consists of’ the elements described herein). This applies equally to steps within a described method as well as devices, systems, and components therein.

[0108] For convenience, the meaning of some terms and phrases used in the specification, examples, and appended claims, are provided below. Unless stated otherwise, or implicit from context, the following terms and phrases include the meanings provided below. The definitions are provided to aid in describing particular embodiments, and are not intended to limit the claimed invention, because the scope of the invention is limited only by the claims. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. If there is an apparent discrepancy between the usage of a term in the art and its definition provided herein, the definition provided within the specification shall prevail.

[0109] The terms “decrease”, “reduced”, “reduction”, or “inhibit” are all used herein to mean a decrease by a statistically significant amount. In some embodiments, “reduce,” “reduction" or “decrease" or “inhibit” typically means a decrease by at least 10% as compared to a reference level (e.g. the absence of a given treatment or agent) and can include, for example, a decrease by at least about 10%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, at least about 98%, at least about 99% , or more. As used herein, “reduction” or “inhibition” does not encompass a complete inhibition or reduction as compared to a reference level. “Complete inhibition” is a 100% inhibition as compared to a reference level. A decrease can be preferably down to a level accepted as within the range of normal for an individual without a given disorder.

[0110] The terms “increased”, “increase”, “enhance”, or “activate” are all used herein to mean an increase by a statically significant amount. In some embodiments, the terms “increased”, “increase”, “enhance”, or “activate” can mean an increase of at least 10% as compared to a reference level, for example an increase of at least about 20%, or at least about 30%, or at least about 40%, or at least about 50%, or at least about 60%, or at least about 70%, or at least about 80%, or at least about 90% or up to and including a 100% increase or any increase between 10-100% as compared to a referencelevel, or at least about a 2-fold, or at least about a 3 -fold, or at least about a 4-fold, or at least about a 5-fold or at least about a 10-fold increase, or any increase between 2-fold and 10-fold or greater as compared to a reference level. In the context of a symptom, an “increase” is a statistically significant increase in such level.

[0111] As used herein, a "subject" means a human or animal. Usually the animal is a vertebrate such as a primate, rodent, domestic animal or game animal. Primates include chimpanzees, cynomolgus monkeys, spider monkeys, and macaques, e.g., Rhesus. Rodents include mice, rats, woodchucks, ferrets, rabbits and hamsters. Domestic and game animals include cows, horses, pigs, deer, bison, buffalo, feline species, e.g., domestic cat, canine species, e.g., dog, fox, wolf, avian species, e.g., chicken, emu, ostrich, and fish, e.g., trout, catfish and salmon. In some embodiments, the subject is a mammal, e.g., a primate, e.g., a human. The terms, “individual,” “patient” and “subject” are used interchangeably herein.

[0112] Preferably, the subject is a mammal. The mammal can be a human, non-human primate, mouse, rat, dog, cat, horse, or cow, but is not limited to these examples. Mammals other than humans can be advantageously used as subjects that represent animal models of spasticity. A subject can be male or female.

[0113] A subject can be one who has been previously diagnosed with or identified as suffering from or having a condition in need of treatment (e.g. spasticity) or one or more complications related to such a condition, and optionally, have already undergone treatment for the condition or the one or more complications related to . Alternatively, a subject can also be one who has not been previously diagnosed as having the condition or one or more complications related to the condition. For example, a subject can be one who exhibits one or more risk factors for the condition or one or more complications related to the condition or a subject who does not exhibit risk factors.

[0114] A “subject in need” of treatment for a particular condition can be a subject having that condition, diagnosed as having that condition, or at risk of developing that condition.

[0115] In some embodiments, the methods described herein relate to measuring, detecting, or determining a movement or aspect thereof. As used herein, the term "detecting" or “measuring” refers to observing a signal from, e.g. gyroscope 110 and / or accelerometer 120 to indicate motion of a device or system described herein (e.g., and of the body the device / system is attached to).

[0116] As used herein, the terms "treat,” "treatment," "treating,” or “amelioration” refer to therapeutic treatments, wherein the object is to reverse, alleviate, ameliorate, inhibit, slow down or stop the progression or severity of a condition associated with a disease or disorder, e.g. spasticity. The term “treating" includes reducing or alleviating at least one adverse effect or symptom of a condition, disease or disorder associated with spasticity. Treatment is generally “effective" if one or more symptoms or clinical markers are reduced. Alternatively, treatment is “effective" if the progression of a disease is reduced or halted. That is, “treatment" includes not just the improvement ofsymptoms or markers, but also a cessation of, or at least slowing of, progress or worsening of symptoms compared to what would be expected in the absence of treatment. Beneficial or desired clinical results include, but are not limited to, alleviation of one or more symptom(s), diminishment of extent of disease, stabilized (z.e., not worsening) state of disease, delay or slowing of disease progression, amelioration or palliation of the disease state, remission (whether partial or total), and / or decreased mortality, whether detectable or undetectable. The term "treatment" of a disease also includes providing relief from the symptoms or side-effects of the disease (including palliative treatment).

[0117] In some embodiments of any of the aspects, the treatment reduces the magnitude of spastic movements. In some embodiments of any of the aspects, the treatment reduces the frequency of spastic movements. In some embodiments of any of the aspects, the treatment reduces the force or speed of spastic movements.

[0118] As used herein, “in communication” refers to any form of interaction between two or more elements or entities, including mechanical, electrical, magnetic, electromagnetic, fluidic, and thermal interaction. Being in communication does not require direct physical touching or contact of the two elements or entities. In some embodiments of any of the aspects, the communication is mechanical communication, e.g., motion in or at a first element / entity / location is able to physical cause motion in a second element / entity / location. In some embodiments of any of the aspects, the communication is electrical communication, e.g., an electrical signal in or at a first element / entity / location is able to be conveyed to a second element / entity / location. In some embodiments, two elements / entities which are in communication, are in contact with each other. As used herein, “in contact with” means that two elements / entities are physically arranged such that the elements / entities themselves are touching, e.g., at least one surface of each element / entity are touching or forming a junction.

[0119] The term “statistically significant" or “significantly" refers to statistical significance and generally means a two standard deviation (2SD) or greater difference.

[0120] Other than in the operating examples, or where otherwise indicated, all numbers expressing quantities of ingredients or reaction conditions used herein should be understood as modified in all instances by the term “about.” The term “about” when used in connection with percentages can mean ±1%.

[0121] As used herein, the term “comprising” means that other elements can also be present in addition to the defined elements presented. The use of “comprising” indicates inclusion rather than limitation.

[0122] The term "consisting of refers to compositions, methods, and respective components thereof as described herein, which are exclusive of any element not recited in that description of the embodiment.

[0123] As used herein the term "consisting essentially of refers to those elements required for a given embodiment. The term permits the presence of additional elements that do not materially affect the basic and novel or functional characteristic(s) of that embodiment of the invention.

[0124] The singular terms "a," "an," and "the" include plural referents unless context clearly indicates otherwise. Similarly, the word "or" is intended to include "and" unless the context clearly indicates otherwise. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of this disclosure, suitable methods and materials are described below. The abbreviation, "e.g." is derived from the Latin exempli gratia, and is used herein to indicate a non-limiting example. Thus, the abbreviation "e.g." is synonymous with the term "for example."

[0125] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.

[0126] Unless otherwise defined herein, scientific and technical terms used in connection with the present application shall have the meanings that are commonly understood by those of ordinary skill in the art to which this disclosure belongs. It should be understood that this invention is not limited to the particular methodology, protocols, and reagents, etc., described herein and as such can vary. The terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention, which is defined solely by the claims.

[0127] Other terms are defined herein within the description of the various aspects of the invention.

[0128] All patents and other publications; including literature references, issued patents, published patent applications, and co-pending patent applications; cited throughout this application are expressly incorporated herein by reference for the purpose of describing and disclosing, for example, the methodologies described in such publications that might be used in connection with the technology described herein. These publications are provided solely for their disclosure prior to the filing date of the present application. Nothing in this regard should be construed as an admission that the inventors are not entitled to antedate such disclosure by virtue of prior invention or for any other reason. All statements as to the date or representation as to the contents of these documents is based on the information available to the applicants and does not constitute any admission as to the correctness of the dates or contents of these documents.

[0129] The description of embodiments of the disclosure is not intended to be exhaustive or to limit the disclosure to the precise form disclosed. While specific embodiments of, and examples for,the disclosure are described herein for illustrative purposes, various equivalent modifications are possible within the scope of the disclosure, as those skilled in the relevant art will recognize. For example, while method steps or functions are presented in a given order, alternative embodiments may perform functions in a different order, or functions may be performed substantially concurrently. The teachings of the disclosure provided herein can be applied to other procedures or methods as appropriate. The various embodiments described herein can be combined to provide further embodiments. Aspects of the disclosure can be modified, if necessary, to employ the compositions, functions and concepts of the above references and application to provide yet further embodiments of the disclosure. These and other changes can be made to the disclosure in light of the detailed description. All such modifications are intended to be included within the scope of the appended claims.

[0130] Specific elements of any of the foregoing embodiments can be combined or substituted for elements in other embodiments. Furthermore, while advantages associated with certain embodiments of the disclosure have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the disclosure.

[0131] In some embodiments, the present technology may be defined in any of the following numbered paragraphs:1. A system comprising: a) at least two vibratory motors; b) at least one gyroscope; and c) at least one accelerometer.2. The system of paragraph 1, further comprising at least one of: d) at least one controller; e) at least one power source; and f) at least one body attachment device.3. The system of any one of the preceding paragraphs, wherein at least one body attachment device is a wrap or strap.4. The system of any one of the preceding paragraphs, wherein at least one body attachment means is a wrap or strap that fully encircles a limb.5. The system of any one of the preceding paragraphs, wherein at least one body attachment means is a wrap or strap that fully encircles a limb above a joint.6. The system of paragraph 5, wherein the joint is a wrist, an ankle, an elbow, or a knee.7. The system of any one of paragraphs 1-3, wherein the at least one body attachment means is a warp or strap that fully encircles a part of the body.The system of paragraph 7, wherein the part of the body is the thoracic cavity, abdomen, back, or cervical region. The system of any one of the preceding paragraphs, wherein the at least one body attachment means comprises a magnetic closure. The system of any one of the preceding paragraphs, wherein at least one body attachment device comprises an adhesive surface. The system of any one of the preceding paragraphs, wherein the at least two vibratory motors are attached to or enclosed by at least one body attachment means. The system of any one of the preceding paragraphs, wherein the at least two vibratory motors are attached to or enclosed by a first body attachment means such that a first vibratory motor can be positioned at the location of a tendon of the first muscle of a set of agonist-antagonist muscles and a second vibratory motor can positioned at the location of a tendon of a second muscle of the set of agonist-antagonist muscles. The system of any one of the preceding paragraphs, wherein: a first body attachment means is provided markings to index the first body attachment means to a specific position on a body; and the at least two vibratory motors are non-movably attached to or are enclosed by the first body attachment means such that, when the body attachment means is indexed to the body, a first vibratory motor is positioned at the location of a tendon of an agonist muscle and a second vibratory motor can positioned at the location of a tendon of a corresponding antagonist muscle. The system of any one of paragraphs 1-12, wherein: a first body attachment means is formed to fit and attach to a body in only one position; and the at least two vibratory motors are non-movably attached to or enclosed by the first body attachment means such that, when the body attachment means is attached to the body, a first vibratory motor is positioned at the location of a tendon of an agonist muscle and a second vibratory motor can positioned at the location of a tendon of a corresponding antagonist muscle. The system of any one of the preceding paragraphs, wherein: the at least two vibratory motors are attached to or enclosed by a first body attachment means; and the first body attachment means comprises a rigid portion at the location of each of the at least two vibratory motors, wherein the rigid portion is or is configured to be more distal from the body than the at least two vibratory motors.The system of any one of paragraphs 1-15, wherein the at least two vibratory motors are implanted or injected in a subject. The system of any one of paragraphs 1-16, wherein the system comprises two or more body attachment means, each body attachment means comprising at least: a) at least two vibratory motors; b) at least one gyroscope; and c) at least one accelerometer. The system of paragraph 17, wherein the at least two vibratory motors, at least one gyroscope, and at least one accelerometer of each body attachment means is in communication with and / or controllable by a single controller. The system of any one of paragraphs 17-18, wherein a first body attachment means is configured or placed above a first joint of a limb and a second body attachment means is configured or placed above a second joint of the limb. The system of any one of paragraphs 1-15, comprising a first body attachment means configured or placed to extend from above a first joint of a limb to above a second joint of the limb; wherein the first body attachment means comprises at least two vibratory motors, at least one gyroscope, and at least one accelerometer above the first joint of the limb and at least two vibratory motors, at least one gyroscope, and at least one accelerometer above the second joint of the limb. The system of any one of paragraphs 19-20, wherein the first joint is a wrist and the second joint is an elbow, or the first joint is an ankle and the second joint is a knee. The system of any one of the preceding paragraphs, wherein a portion of the at least two vibratory motors which is or is configured to be most distal from the body is rigid. The system of any one of the preceding paragraphs, comprising only two vibratory motors. The system of any one of the preceding paragraphs, wherein only two vibratory motors are attached to or enclosed by each body attachment means. The system of any one of the preceding paragraphs, wherein the controller and / or power source are physically connected to or connectable with one or more of the at least two vibratory motors, at least one gyroscope, and at least one accelerometer. The system of any one of the preceding paragraphs, wherein the controller and / or power source are wirelessly connected to or connectable with one or more of the at least two vibratory motors, at least one gyroscope, and at least one accelerometer. The system of any one of the preceding paragraphs, wherein the power source comprises a battery, a cord, and / or a wireless power source. The system of any one of the preceding paragraphs, further comprising at least one of a receiver, antenna, and / or transmitter.The system of any one of the preceding paragraphs, wherein the at least two vibratory motors are configured to provide vibration in the range of 60-100 Hz. The system of any one of the preceding paragraphs, wherein the at least gyroscope and at least accelerometer are configured to detect movement of the body. The system of any one of the preceding paragraphs, wherein the controller is configured to activate at least one of the at least two vibratory motors when body motion is detected. The system of any one of the preceding paragraphs, wherein the controller is configured to activate less than all of the at least two vibratory motors when body motion is detected. The system of any one of the preceding paragraphs, wherein the controller is configured to separately control activation of each of the at least two vibratory motors when body motion is detected. The system of any one of the preceding paragraphs, wherein the controller is configured to: classify a detected body movement; assign an agonist muscle position and antagonist muscle position for the classified detected body movement; and activate at least one vibratory motor at the location of the assigned antagonist muscle position. The system of any one of the preceding paragraphs, wherein the controller is configured to: classify a detected body movement; assign an agonist muscle position and / or antagonist muscle position for the classified detected body movement; and activate at least one vibratory motor at the location of the assigned antagonist muscle position until the body movement a) slows below a threshold speed, b) changes direction or c) exhibits acceleration within certain bounds. The system of any one of the preceding paragraphs, wherein the controller is configured to: classify a detected body movement; assign an agonist muscle position and antagonist muscle position for the classified detected body movement; and activate at least one vibratory motor at the location of the assigned antagonist muscle position until the body movement changes direction or acceleration; active at least one vibratory motor at the location of the assigned agonist muscle position until the body movement slows below a threshold speed. The system of any one of the preceding paragraphs, wherein the controller configured to separately control activation of i) at least one vibratory motor at the location of the assigned antagonist muscle position and ii) at least one vibratory motor at the location of the assigned agonist muscle position.37. A method of treating spasticity in a subject in need thereof, comprising: placing at least one body attachment means of a system of any one of paragraphs 1-36 on the subject, or injecting or implanting the at least two vibration motors of any one of paragraphs 1-36 in the subject; whereby the at least one accelerometer and / or at least one gyroscope of the system detects body movement of the subject; the controller classifies the detected body movement and assigns an agonist muscle position and / or antagonist muscle position for the classified detected body movement; and the controller activates at least one vibratory motor at the location of the assigned antagonist or agonist muscle position.38. The method of paragraph 37, wherein the controller separately controls activation of each of the at least two vibratory motors when body motion is detected.39. The method of paragraph 37, wherein the controller separately controls activation of i) at least one vibratory motor at the location of the assigned antagonist muscle position and ii) at least one vibratory motor at the location of the assigned agonist muscle position.40. The method of any one of paragraphs 37-39, wherein the controller: classifies a detected body movement; assigns an agonist muscle position and antagonist muscle position for the classified detected body movement; and activates at least one vibratory motor at the location of the assigned antagonist muscle position until the body movement slows below a threshold speed or the body movement a) slows below a threshold speed, b) changes direction or c) exhibits acceleration within certain bounds.41. The method of any one of paragraphs 37-40, wherein the controller: classifies a detected body movement; assigns an agonist muscle position and antagonist muscle position for the classified detected body movement; and activates at least one vibratory motor at the location of the assigned antagonist muscle position until the body movement changes direction or acceleration; activates at least one vibratory motor at the location of the assigned agonist muscle position until the body movement slows below a threshold speed.

[0132] In some embodiments, the present technology may be defined in any of the following numbered paragraphs:1. A system or device comprising: a) at least two vibratory motors;b) at least one gyroscope; and c) at least one accelerometer. The system or device of paragraph 1, further comprising at least one of: g) at least one controller; h) at least one power source; and i) at least one body attachment means. The system or device of any one of the preceding paragraphs, wherein at least one body attachment means is a wrap or strap. The system or device of any one of the preceding paragraphs, wherein at least one body attachment means is a wrap or strap that fully encircles a limb. The system or device of any one of the preceding paragraphs, wherein at least one body attachment means is a wrap or strap that fully encircles a limb above a joint. The system or device of paragraph 5, wherein the joint is a wrist, an ankle, an elbow, or a knee. The system or device of any one of paragraphs 1-3, wherein the at least one body attachment means is a warp or strap that fully encircles a part of the body. The system or device of paragraph 7, wherein the part of the body is the thoracic cavity, abdomen, back, or cervical region. The system or device of any one of the preceding paragraphs, wherein the at least one body attachment means comprises a magnetic closure. The system or device of any one of the preceding paragraphs, wherein at least one body attachment means comprises an adhesive surface. The system or device of any one of the preceding paragraphs, wherein the at least two vibratory motors are attached to or enclosed by at least one body attachment means. The system or device of any one of the preceding paragraphs, wherein the at least two vibratory motors are attached to or enclosed by a first body attachment means such that a first vibratory motor can be positioned at the location of a tendon of the first muscle of a set of agonist-antagonist muscles and a second vibratory motor can positioned at the location of a tendon of a second muscle of the set of agonist-antagonist muscles. The system or device of any one of the preceding paragraphs, wherein: a first body attachment means is provided markings to index the first body attachment means to a specific position on a body; and the at least two vibratory motors are non-movably attached to or are enclosed by the first body attachment means such that, when the body attachment means is indexed to the body, a first vibratory motor is positioned at the location of a tendon of an agonistmuscle and a second vibratory motor can positioned at the location of a tendon of a corresponding antagonist muscle. The system or device of any one of paragraphs 1-12, wherein: a first body attachment means is formed to fit and attach to a body in only one position; and the at least two vibratory motors are non-movably attached to or enclosed by the first body attachment means such that, when the body attachment means is attached to the body, a first vibratory motor is positioned at the location of a tendon of an agonist muscle and a second vibratory motor can positioned at the location of a tendon of a corresponding antagonist muscle. The system or device of any one of the preceding paragraphs, wherein: the at least two vibratory motors are attached to or enclosed by a first body attachment means; and the first body attachment means comprises a rigid portion at the location of each of the at least two vibratory motors, wherein the rigid portion is or is configured to be more distal from the body than the at least two vibratory motors. The system or device of any one of paragraphs 1-2, wherein the at least two vibratory motors are implanted or injected in a subject. The system or device of any one of paragraphs 1-15, wherein the system or device comprises two or more body attachment means, each body attachment means comprising at least: a) at least two vibratory motors; b) at least one gyroscope; and c) at least one accelerometer. The system or device of paragraph 17, wherein the at least two vibratory motors, at least one gyroscope, and at least one accelerometer of each body attachment means is in communication with and / or controllable by a single controller. The system or device of any one of paragraphs 17-18, wherein a first body attachment means is configured or placed above a first joint of a limb and a second body attachment means is configured or placed above a second joint of the limb. The system or device of any one of paragraphs 1-15, comprising a first body attachment means configured or placed to extend from above a first joint of a limb to above a second joint of the limb; wherein the first body attachment means comprises at least two vibratory motors, at least one gyroscope, and at least one accelerometer above the first joint of the limb and at least two vibratory motors, at least one gyroscope, and at least one accelerometer above the second joint of the limb.The system or device of any one of paragraphs 19-20, wherein the first joint is a wrist and the second joint is an elbow, or the first joint is an ankle and the second joint is a knee. The system or device of any one of the preceding paragraphs, wherein a portion of the at least two vibratory motors which is or is configured to be most distal from the body is rigid. The system or device of any one of the preceding paragraphs, comprising only two vibratory motors.The system or device of any one of the preceding paragraphs, wherein only two vibratory motors are attached to or enclosed by each body attachment means. The system or device of any one of the preceding paragraphs, wherein the controller and / or power source are physically connected to or connectable with one or more of the at least two vibratory motors, at least one gyroscope, and at least one accelerometer. The system or device of any one of the preceding paragraphs, wherein the controller and / or power source are wirelessly connected to or connectable with one or more of the at least two vibratory motors, at least one gyroscope, and at least one accelerometer. The system or device of any one of the preceding paragraphs, wherein the power source comprises a battery, a cord, and / or a wireless power source. The system or device of any one of the preceding paragraphs, further comprising at least one of a receiver, antenna, and / or transmitter. The system or device of any one of the preceding paragraphs, wherein the at least two vibratory motors are configured to provide vibration in the range of 60-100 Hz. The system or device of any one of the preceding paragraphs, wherein the at least one gyroscope and at least one accelerometer are configured to detect movement of the body. The system or device of any one of the preceding paragraphs, wherein the controller is configured to activate at least one of the at least two vibratory motors when body motion is detected. The system or device of any one of the preceding paragraphs, wherein the controller is configured to activate less than all of the at least two vibratory motors when body motion is detected. The system or device of any one of the preceding paragraphs, wherein the controller is configured to separately control activation of each of the at least two vibratory motors when body motion is detected. The system or device of any one of the preceding paragraphs, wherein the controller is configured to: classify a detected body movement;assign an agonist muscle position and antagonist muscle position for the classified detected body movement; and activate at least one vibratory motor at the location of the assigned antagonist muscle position. The system or device of any one of the preceding paragraphs, wherein the controller is configured to: classify a detected body movement; assign an agonist muscle position and / or antagonist muscle position for the classified detected body movement; and activate at least one vibratory motor at the location of the assigned antagonist muscle position until the body movement a) slows below a threshold speed, b) changes direction or c) exhibits acceleration within certain bounds. The system or device of any one of the preceding paragraphs, wherein the controller is configured to: classify a detected body movement; assign an agonist muscle position and antagonist muscle position for the classified detected body movement; and activate at least one vibratory motor at the location of the assigned antagonist muscle position until the body movement changes direction or acceleration; active at least one vibratory motor at the location of the assigned agonist muscle position until the body movement slows below a threshold speed. The system or device of any one of the preceding paragraphs, wherein the controller is configured to separately control activation of i) at least one vibratory motor at the location of the assigned antagonist muscle position and ii) at least one vibratory motor at the location of the assigned agonist muscle position. A method of treating spasticity in a subject in need thereof, comprising: placing at least one body attachment means of a system or device of any one of paragraphs 1-36 on the subject, or injecting or implanting the at least two vibration motors of any one of paragraphs 1-36 in the subject; whereby the at least one accelerometer and / or at least one gyroscope of the system or device detects body movement of the subject; the controller classifies the detected body movement and assigns an agonist muscle position and / or antagonist muscle position for the classified detected body movement; and the controller activates at least one vibratory motor at the location of the assigned antagonist or agonist muscle position.38. The method of paragraph 37, wherein the controller separately controls activation of each of the at least two vibratory motors when body motion is detected.39. The method of paragraph 37, wherein the controller separately controls activation of i) at least one vibratory motor at the location of the assigned antagonist muscle position and ii) at least one vibratory motor at the location of the assigned agonist muscle position.40. The method of any one of paragraphs 37-39, wherein the controller: classifies a detected body movement; assigns an agonist muscle position and antagonist muscle position for the classified detected body movement; and activates at least one vibratory motor at the location of the assigned antagonist muscle position until the body movement slows below a threshold speed or the body movement a) slows below a threshold speed, b) changes direction or c) exhibits acceleration within certain bounds.41. The method of any one of paragraphs 37-40, wherein the controller: classifies a detected body movement; assigns an agonist muscle position and antagonist muscle position for the classified detected body movement; activates at least one vibratory motor at the location of the assigned antagonist muscle position until the body movement changes direction or acceleration; and / or activates at least one vibratory motor at the location of the assigned agonist muscle position until the body movement slows below a threshold speed.

[0133] The technology described herein is further illustrated by the following examples which in no way should be construed as being further limiting.EXAMPLESExample 1

[0134] Spasticity, a condition characterized by muscle stiffness and involuntary contractions, commonly arises from neurological disorders like multiple sclerosis and cerebral palsy. Some of the main treatments include:1. Oral Medications: Oral muscle relaxants and antispasmodic medications like baclofen, tizanidine, and dantrolene are commonly prescribed to reduce muscle tone and spasticity.2. Intramuscular Injections of Botulinum Toxin: Botulinum toxin injections, such as Botox or Dysport, are used to temporarily paralyze or weaken specific muscles, reducing spasticity. These injections are often targeted at specific muscle groups to improve mobility and function.3. Physical Therapy: Physical therapy plays a crucial role in managing spasticity. Therapists work with patients to improve range of motion, strength, and flexibility through exercises, stretching, and other techniques.4. Occupational Therapy: Occupational therapists focus on enhancing daily living skills and functional independence by addressing fine motor control and adaptive strategies.5. Splinting and Orthotics: Customized splints or orthotic devices can help prevent contractures and provide support to affected limbs, improving overall mobility and reducing discomfort.6. Intrathecal Baclofen Therapy: For severe cases of spasticity, a pump can be surgically implanted to deliver baclofen directly into the spinal fluid, providing more targeted and consistent relief.7. Surgical Interventions: Surgical procedures such as tendon lengthening, neurectomy, and rhizotomy may be considered when other treatments are ineffective or in cases of severe spasticity. Dorsal Rhizotomy: During the procedure, a neurosurgeon selectively cuts or severs certain sensory nerve roots in the spinal cord's dorsal (back) region. This disrupts the transmission of abnormal nerve signals responsible for muscle spasticity and involuntary movements. Dorsal rhizotomy aims to reduce muscle stiffness and improve mobility, leading to increased functional independence for the patient. This procedure is typically considered for individuals who have not responded well to other treatments and have significant spasticity affecting their quality of life.8. Nerve Blocks: Local anesthetic injections or nerve blocks can provide temporary relief by disrupting nerve signals and reducing muscle spasm.9. Functional Electrical Stimulation (FES): FES devices use electrical impulses to stimulate muscles, promoting muscle movement and reducing spasticity.10. Intravenous Treatments: Intravenous medications like diazepam or phenol can be used in some cases to provide short-term relief from severe spasticity.

[0135] Agonist and antagonist muscles are pairs of muscles that work together to create controlled movements around joints. They have opposing actions that help maintain balance and control during motion.1. Agonist Muscle: The agonist muscle is also known as the prime mover. It is responsible for initiating and controlling a specific movement. When the agonist muscle contracts, it generates the force necessary to perform a desired action. For example, during a bicep curl, the biceps brachii muscle is the agonist muscle responsible for flexing the elbow joint.2. Antagonist Muscle: The antagonist muscle opposes the action of the agonist muscle. When the agonist muscle contracts to produce a movement, the antagonist muscle relaxes to allow that movement to occur smoothly. It acts as a "brake" to control the speed and precision of themovement. In the bicep curl example, the triceps brachii muscle is the antagonist muscle. It extends the elbow joint, counteracting the flexion produced by the biceps.

[0136] Spasticity can significantly impact sensory reflexes due to the underlying neurological changes that occur in conditions like cerebral palsy, stroke, or spinal cord injuries. Sensory reflexes involve the automatic response of muscles to external stimuli, and they play a critical role in maintaining balance, coordination, and movement control. With spasticity, there is an abnormal increase in muscle tone and involuntary muscle contractions. This can lead to alterations in sensory reflexes in several ways:1. Hyperactive Reflexes: Spasticity often leads to hyperactive reflexes, where the normal reflex response to a stimulus becomes exaggerated. For instance, tapping the knee tendon in someone with spasticity might result in a more pronounced and prolonged knee jerk response due to the heightened sensitivity of the muscle's reflex arc.2. Clonus: Clonus is a repetitive, rhythmic, and involuntary muscle contraction and relaxation that occurs due to sustained stretch on a muscle. It can be triggered by sensory stimuli and is often associated with spasticity. For example, in the ankle clonus test, dorsiflexing the foot might lead to a series of rapid contractions and relaxations in individuals with spasticity.3. Altered Reflex Threshold: Spasticity can lower the threshold at which reflexes are triggered. Even minor stimuli can lead to stronger and more persistent reflex responses compared to individuals without spasticity.4. Incoordination: The disrupted communication between agonist and antagonist muscles in spasticity can lead to sensory reflexes that are less coordinated and more jerky, resulting in difficulties with fine motor control.

[0137] Described herein are methods, devices, and systems for the treatment of spasticity. Vibration drives muscle spindle activity. Cessation of vibration leads to generally decreased muscle spindle activity that recovers to normal over 10s of seconds. Driving vibration creates illusion of longer muscle while cessation of vibration creates illusion of shorter muscle.

[0138] Exemplary closed-loop wearable device for the management of spasticity

[0139] Vibratory motors within a device (e.g., Fig. 2) worn on a region of limbs, above ajoint(wrist, ankle, above elbow, above the knees) (Fig. 1) are activated in response to movement of the limb. Motors are positioned over the tendons of the main mover muscles. Gyroscopes and accelerometer sensors are embedded within the device and pick up the movement of the limb. Vibration is performed between 60-100 Hz, resulting in illusory activation of the spindle response in the applied of the muscle. This mechanism is used to override hyperactive reflexes in the antagonist muscles in spastic patients which cause co-contraction.

[0140] In a healthy condition, when the agonist fires (e.g., the triceps), the bicep spindles activate, reciprocal inhibition occurs, and the bicep relaxes. Reciprocal inhibition describes the relaxation or stretching of one muscle to inhibit the activity of an opposing muscle.

[0141] In a spastic condition, when the agonist fires (e.g., the triceps), the bicep spindles activate, reciprocal inhibition is inadequate and / or co-conctraction occur, and the bicep activates.

[0142] With the device described herein, when the agonist fires (e.g., the triceps), the tricep spindles are activated by the vibration from the device, velocity-dependent contraction occurs (created in spastic patients, the bicep relaxes, and the triceps activate. The bicep spindles are activated but are overridden by the tricep spindle activation, which minimizes bicep activation. Alternatively, with the device described herein, when the agonist fires (e.g., the triceps), the bicep spindles are activated by the vibration from the device, reciprocal contraction occurs, the bicep relaxes, and the triceps activate.

[0143] Research shows that vibration causes an illusory spindle response at frequencies between 60-100 Hz. This device will amplify the spindle feedback in spastic patients.

Claims

What is claimed herein is:

1. A system or device comprising: a) at least two vibratory motors; b) at least one gyroscope; and c) at least one accelerometer.

2. The system or device of claim 1, further comprising at least one of: j) at least one controller; k) at least one power source; and l) at least one body attachment means.

3. The system or device of any one of the preceding claims, wherein at least one body attachment means is a wrap or strap.

4. The system or device of any one of the preceding claims, wherein at least one body attachment means is a wrap or strap that fully encircles a limb.

5. The system or device of any one of the preceding claims, wherein at least one body attachment means is a wrap or strap that fully encircles a limb above a joint.

6. The system or device of claim 5, wherein the joint is a wrist, an ankle, an elbow, or a knee.

7. The system or device of any one of claims 1-3, wherein the at least one body attachment means is a warp or strap that fully encircles a part of the body.

8. The system or device of claim 7, wherein the part of the body is the thoracic cavity, abdomen, back, or cervical region.

9. The system or device of any one of the preceding claims, wherein the at least one body attachment means comprises a magnetic closure.

10. The system or device of any one of the preceding claims, wherein at least one body attachment means comprises an adhesive surface.

11. The system or device of any one of the preceding claims, wherein the at least two vibratory motors are attached to or enclosed by at least one body attachment means.

12. The system or device of any one of the preceding claims, wherein the at least two vibratory motors are attached to or enclosed by a first body attachment means such that a first vibratory motor can be positioned at the location of a tendon of the first muscle of a set of agonistantagonist muscles and a second vibratory motor can positioned at the location of a tendon of a second muscle of the set of agonist-antagonist muscles.

13. The system or device of any one of the preceding claims, wherein: a first body attachment means is provided markings to index the first body attachment means to a specific position on a body; andthe at least two vibratory motors are non-movably attached to or are enclosed by the first body attachment means such that, when the body attachment means is indexed to the body, a first vibratory motor is positioned at the location of a tendon of an agonist muscle and a second vibratory motor can positioned at the location of a tendon of a corresponding antagonist muscle.

14. The system or device of any one of claims 1-12, wherein: a first body attachment means is formed to fit and attach to a body in only one position; and the at least two vibratory motors are non-movably attached to or enclosed by the first body attachment means such that, when the body attachment means is attached to the body, a first vibratory motor is positioned at the location of a tendon of an agonist muscle and a second vibratory motor can positioned at the location of a tendon of a corresponding antagonist muscle.

15. The system or device of any one of the preceding claims, wherein: the at least two vibratory motors are attached to or enclosed by a first body attachment means; and the first body attachment means comprises a rigid portion at the location of each of the at least two vibratory motors, wherein the rigid portion is or is configured to be more distal from the body than the at least two vibratory motors.

16. The system or device of any one of claims 1-2, wherein the at least two vibratory motors are implanted or injected in a subject.

17. The system or device of any one of claims 1-15, wherein the system or device comprises two or more body attachment means, each body attachment means comprising at least: a) at least two vibratory motors; b) at least one gyroscope; and c) at least one accelerometer.

18. The system or device of claim 17, wherein the at least two vibratory motors, at least one gyroscope, and at least one accelerometer of each body attachment means is in communication with and / or controllable by a single controller.

19. The system or device of any one of claims 17-18, wherein a first body attachment means is configured or placed above a first joint of a limb and a second body attachment means is configured or placed above a second joint of the limb.

20. The system or device of any one of claims 1-15, comprising a first body attachment means configured or placed to extend from above a first joint of a limb to above a second joint of the limb; wherein the first body attachment means comprises at least two vibratory motors, at least one gyroscope, and at least one accelerometer above the first joint of the limb and atleast two vibratory motors, at least one gyroscope, and at least one accelerometer above the second joint of the limb.

21. The system or device of any one of claims 19-20, wherein the first joint is a wrist and the second joint is an elbow, or the first joint is an ankle and the second joint is a knee.

22. The system or device of any one of the preceding claims, wherein a portion of the at least two vibratory motors which is or is configured to be most distal from the body is rigid.

23. The system or device of any one of the preceding claims, comprising only two vibratory motors.The system or device of any one of the preceding claims, wherein only two vibratory motors are attached to or enclosed by each body attachment means.

24. The system or device of any one of the preceding claims, wherein the controller and / or power source are physically connected to or connectable with one or more of the at least two vibratory motors, at least one gyroscope, and at least one accelerometer.

25. The system or device of any one of the preceding claims, wherein the controller and / or power source are wirelessly connected to or connectable with one or more of the at least two vibratory motors, at least one gyroscope, and at least one accelerometer.

26. The system or device of any one of the preceding claims, wherein the power source comprises a battery, a cord, and / or a wireless power source.

27. The system or device of any one of the preceding claims, further comprising at least one of a receiver, antenna, and / or transmitter.

28. The system or device of any one of the preceding claims, wherein the at least two vibratory motors are configured to provide vibration in the range of 60-100 Hz.

29. The system or device of any one of the preceding claims, wherein the at least one gyroscope and at least one accelerometer are configured to detect movement of the body.

30. The system or device of any one of the preceding claims, wherein the controller is configured to activate at least one of the at least two vibratory motors when body motion is detected.

31. The system or device of any one of the preceding claims, wherein the controller is configured to activate less than all of the at least two vibratory motors when body motion is detected.

32. The system or device of any one of the preceding claims, wherein the controller is configured to separately control activation of each of the at least two vibratory motors when body motion is detected.

33. The system or device of any one of the preceding claims, wherein the controller is configured to: classify a detected body movement; assign an agonist muscle position and antagonist muscle position for the classified detected body movement; and activate at least one vibratory motor at the location of the assigned antagonist muscle position.

34. The system or device of any one of the preceding claims, wherein the controller is configured to: classify a detected body movement; assign an agonist muscle position and / or antagonist muscle position for the classified detected body movement; and activate at least one vibratory motor at the location of the assigned antagonist muscle position until the body movement a) slows below a threshold speed, b) changes direction or c) exhibits acceleration within certain bounds.

35. The system or device of any one of the preceding claims, wherein the controller is configured to: classify a detected body movement; assign an agonist muscle position and antagonist muscle position for the classified detected body movement; and activate at least one vibratory motor at the location of the assigned antagonist muscle position until the body movement changes direction or acceleration; active at least one vibratory motor at the location of the assigned agonist muscle position until the body movement slows below a threshold speed.

36. The system or device of any one of the preceding claims, wherein the controller is configured to separately control activation of i) at least one vibratory motor at the location of the assigned antagonist muscle position and ii) at least one vibratory motor at the location of the assigned agonist muscle position.

37. A method of treating spasticity in a subject in need thereof, comprising: placing at least one body attachment means of a system or device of any one of claims 1- 36 on the subject, or injecting or implanting the at least two vibration motors of any one of claims 1-36 in the subject; whereby the at least one accelerometer and / or at least one gyroscope of the system or device detects body movement of the subject;the controller classifies the detected body movement and assigns an agonist muscle position and / or antagonist muscle position for the classified detected body movement; and the controller activates at least one vibratory motor at the location of the assigned antagonist or agonist muscle position.

38. The method of claim 37, wherein the controller separately controls activation of each of the at least two vibratory motors when body motion is detected.

39. The method of claim 37, wherein the controller separately controls activation of i) at least one vibratory motor at the location of the assigned antagonist muscle position and ii) at least one vibratory motor at the location of the assigned agonist muscle position.

40. The method of any one of claims 37-39, wherein the controller: classifies a detected body movement; assigns an agonist muscle position and antagonist muscle position for the classified detected body movement; and activates at least one vibratory motor at the location of the assigned antagonist muscle position until the body movement slows below a threshold speed or the body movement a) slows below a threshold speed, b) changes direction or c) exhibits acceleration within certain bounds.

41. The method of any one of claims 37-40, wherein the controller: classifies a detected body movement; assigns an agonist muscle position and antagonist muscle position for the classified detected body movement; activates at least one vibratory motor at the location of the assigned antagonist muscle position until the body movement changes direction or acceleration; and / or activates at least one vibratory motor at the location of the assigned agonist muscle position until the body movement slows below a threshold speed.

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