Methods and systems for treatment of spinal disorders using trans-spinal direct current stimulation

Abstract

Methods, systems and devices are disclosed for treating a spinal disorder by applying a source of direct current to a spinal cord in animals, including humans. Trans-spinal direct current stimulation (tsDCS) uses direct current via cathodal and/or anodal stimulation to induce cell proliferation, cell differentiation, and/or cell migration at or near the area of the spinal cord being treated, and up-regulates or down-regulates protein expression by cells at or near the area of the spinal cord being treated.

What is claimed is: 
     
         1 . A stimulation device for regulating biological activity associated with the spine including at least one of protein expression level and cell behavior to promote at least one of proliferation, differentiation, migration and expression, comprising:
 a. a direct current voltage source having a plurality of terminals;   b. a first of the terminals for connecting a first electrode to the direct current source;   c. a second of the terminals for connecting a second electrode to the direct current source; and   d. a control circuit for controlling voltage available at the first and second terminals for enabling control of current flow between the electrodes.   
     
     
         2 . The device of  claim 1  wherein the control circuit further includes a signal controller circuit configured to maintain the current flow at a constant level between the first and second electrodes in response to changes in voltage across the first and second terminals. 
     
     
         3 . The device of  claim 2  further including an intelligent controller for executing stored routines for operation of the device. 
     
     
         4 . The device of  claim 3  further including a memory unit for providing data to the intelligent controller for operation of the device. 
     
     
         5 . The device of  claim 1  further including a signal controller circuit configured to be in electrical communication with at least one of the electrodes and the direct current source, the signal controller circuit capable of controlling the character of current flow between the electrodes in response to changes in voltage across the first and second terminals for maintaining constant current flow between the electrodes. 
     
     
         6 . The device of  claim 1  wherein the direct current source is a battery and the terminals are associated with the battery. 
     
     
         7 . The device of  claim 1  wherein the device is configured to deliver trans-spinal direct current stimulation across a target section of the spine. 
     
     
         8 . The device of  claim 1  further including an intelligent controller for executing stored routines for operating said device. 
     
     
         9 . The device of  claim 1  wherein the control circuit includes an on/off switch. 
     
     
         10 . The device of  claim 2  wherein the control circuit is configured to provide said current flow including at least one of continuous, pulsed, intermittent, varying, and non-varying current flow. 
     
     
         11 . The device of  claim 1  wherein the control circuit is configured to provide said current flow including at least one of continuous, pulsed, intermittent, varying, and non-varying current flow. 
     
     
         12 . The device of  claim 1  wherein the direct current source is a battery, further comprising a housing, wherein the direct current source and the terminals are supported by the housing. 
     
     
         13 . The device of  claim 12 , wherein the housing is wearable and configured to secure the direct current source to the vertebrate being and to permit the being to be mobile while the device is in operation. 
     
     
         14 . The device of  claim 13  wherein a surface of the housing includes an electrode surface for attachment of the first electrode directly to the being in the area of the dorsal aspect. 
     
     
         15 . The device of  claim 13  wherein the device is presented as a wearable package, wherein a surface of the package is configured to be applied to a target dorsal location as an electrode. 
     
     
         16 . The device of  claim 15  wherein said surface is configured to present a conductive electrode connected to the DC source. 
     
     
         17 . The device of  claim 16  wherein the surface includes an electrically conductive adhesive. 
     
     
         18 . The device of  claim 16  wherein the surface is magnetic and electrically conductive. 
     
     
         19 . The device of  claim 13  wherein the wearable material includes an attachment device that includes at least one of a strap, cloth, elastic, harness, and belt attachment, configured to allow the electrode surface to be in contact with the skin of the vertebrate. 
     
     
         20 . The device of  claim 19  wherein at least one lead for the return electrode is affixed to and runs along the attachment device to make electrical contact via the return electrode to provide the desired ventral electrical connection to the patient. 
     
     
         21 . The device of  claim 19  wherein the lead for the return electrode lead is connected to the current source wherein the connection is done using at least one of a sealed pass-through and a port in the housing. 
     
     
         22 . The device of  claim 1  wherein the device is wearable and configured to be attached to the skin surface of the spine at one or more of the cervical, thoracic, lumbar and sacral levels depending on the site to be treated. 
     
     
         23 . The device of  claim 22  having an intelligent controller controlled by at least one of a human interface and internal circuit control by using protocol data stored in a memory, to establish circuit connection between the electrodes and the terminals, respectively, according to data obtained from the memory to enable a treatment by a chosen protocol. 
     
     
         24 . The device of  claim 1  wherein a surface of the housing includes an electrode surface for attachment of the first electrode directly to the being in the area of the dorsal aspect. 
     
     
         25 . A device for treating a spinal cord condition in a vertebrate being by applying stimulation at the dorsal aspect of the spinal cord at a site of the condition to regulate biological activity including at least one of protein expression level and cell behavior to promote at least one of proliferation, differentiation, migration and expression, comprising:
 a. a direct current source having a plurality of terminals;   b. a first of the terminals for connecting a first electrode to the direct current source;   c. a second of the terminals for connecting a second electrode to the direct current source;   d. a circuit to control the direction of current flow between the first electrode and the second electrode;   e. a circuit in electrical communication with at least one of the electrodes and the direct current source, the circuit for maintaining constant current flow between the electrodes in response to changes in voltage at the first and second terminals; and   f. wherein the direct current source is a battery.   
     
     
         26 . The device of  claim 25  further comprising a wearable housing configured to secure the direct current source to the vertebrate being and to permit the being to be mobile while the device is in operation. 
     
     
         27 . The device of  claim 26  wherein a surface of the housing includes an electrode surface for attachment of the first electrode directly to the being in the area of the dorsal aspect. 
     
     
         28 . The device of  claim 27  further including an intelligent controller for executing stored routines for delivering trans-spinal direct current stimulation during operation of the device. 
     
     
         29 . The device of  claim 28  further including a memory unit for providing data to the intelligent controller for operation of the device according to stored data. 
     
     
         30 . The device of  claim 29  wherein the intelligent controller controls the signal applied to the electrodes and controls the direction of current flow between the first electrode and the second electrode. 
     
     
         31 . The device of  claim 26  further including a signal controller circuit configured to be in electrical communication with at least one of the electrodes and the direct current source, the signal controller circuit capable of controlling the character of current flow between the electrodes in response to changes in voltage across the first and second terminals for maintaining constant current flow between the electrodes. 
     
     
         32 . The device of  claim 31  wherein the signal controller circuit is further configured to regulate the DC signal to provide the stimulation signal  126  as at least one of constant, continuous, pulsed, intermittent, varying, and non-varying as directed by the intelligent controller. 
     
     
         33 . The device of  claim 26  wherein the direct current source is a battery and the terminals are associated with the battery. 
     
     
         34 . The device of  claim 25  wherein at least one of the electrodes comprises an array of electrodes, said array of electrodes being driven in a pattern according to a pattern controller circuit. 
     
     
         35 . The device of  claim 34  wherein the pattern controller circuit is instructed by intelligent controller  112 , drives a desired stimulation pattern for the array of electrodes. 
     
     
         36 . The device of  claim 35  wherein the pattern controller circuit is configured to drive the array of electrodes to give target cells a rotational motion component. 
     
     
         37 . The device of  claim 35  wherein the pattern controller circuit is configured to drive the array of electrodes to give target cells an angular motion component. 
     
     
         38 . The device of  claim 26  having a control circuit including a signal controller circuit for maintaining constant current flow, an intelligent controller circuit for control of the direction of current flow, a DC source, a user interface, and a memory, supported in a housing, having a configuration of at least one of benchtop, wearable, and implantable. 
     
     
         39 . The device of  claim 38  wherein the circuit for maintaining constant current flow between the electrodes includes a signal controller circuit configured to regulate the DC signal to provide the stimulation signal as at least one of constant, continuous, pulsed, intermittent, varying, and non-varying as directed by the intelligent controller circuit. 
     
     
         40 . The device of  claim 38  wherein the direct current source is a rechargeable battery. 
     
     
         41 . The device of  claim 40  wherein the housing is wearable and water tight.