Method and system for therapeutic brain stimulation using electromagnetic pulses

Abstract

A therapeutic or diagnostic system comprises a non-invasive brain stimulation device (such as a TMS stimulation device) or other neuromodulation device configured to stimulate a patient's brain or nervous system by emitting electromagnetic pulses according to stimulation parameters, such as a pulse frequency or burst repetition frequency or other parameters, that provides surprising improvements in responsiveness and/or may require only a relatively short train of pulses to achieve high efficacy. In particular, stimulation pulses may be delivered at a frequency of between 12 and 40 Hertz with a 3 to 5 ratio as compared with burst repetition frequency, or at other specific patterns within that range. The stimulation parameters may be pre-stored and customized to individual patients, being identified through an automated search routine during which patient feedback is monitored. A user interface may be provided to allow an operator to conveniently select the appropriate parameters for the desired treatment.

What is claimed is: 
     
         1 . A therapeutic or diagnostic device for delivering artificial stimulating pulses to a human subject, comprising:
 a set of stored stimulation parameters determining a theta burst stimulation sequence, the set of stored stimulation parameters including at least a pulse frequency parameter selected in a range from 12 to 28 Hertz and a burst repetition frequency parameter having a value that is different than the pulse frequency parameter; and   a neurological stimulation device configured to stimulate the human subject's brain or nervous system by repetitively emitting electromagnetic pulses according to the set of stored stimulation parameters, the electromagnetic pulses arranged in a plurality of bursts each comprising at least two electromagnetic pulses spaced according to the pulse frequency parameter, the bursts being spaced according to the burst repetition frequency parameter.   
     
     
         2 . The therapeutic or diagnostic device of  claim 1 , wherein the burst repetition frequency parameter is selected in a range from 3 to 8 Hertz. 
     
     
         3 . The therapeutic or diagnostic device of  claim 2 , wherein the pulse frequency parameter is selected in a range from 16 to 28 Hertz. 
     
     
         4 . The therapeutic or diagnostic device of  claim 3 , wherein the burst repetition frequency parameter is selected in a range from 4 to 7 Hertz. 
     
     
         5 . The therapeutic or diagnostic device of  claim 4 , wherein the pulse frequency parameter is selected in a range from 19 to 21 Hertz, and the number of electromagnetic pulses per burst is three. 
     
     
         6 . The therapeutic or diagnostic device of  claim 5 , wherein the burst repetition frequency parameter is selected in a range from 5 to 6 Hertz. 
     
     
         7 . The therapeutic or diagnostic device of  claim 4 , wherein the pulse frequency parameter is selected in a range from 22 to 26 Hertz, and the number of electromagnetic pulses per burst is two. 
     
     
         8 . The therapeutic or diagnostic device of  claim 7 , wherein the burst repetition frequency parameter is selected in the range from 5 to 6 Hertz. 
     
     
         9 . The therapeutic or diagnostic device of  claim 1 , wherein the burst repetition frequency parameter is selected so that the ratio of the pulse frequency parameter to the burst repetition frequency parameter is in the range from 3 to 5. 
     
     
         10 . The therapeutic or diagnostic device of  claim 1 , wherein the bursts are arranged in a plurality of trains, each train comprising a plurality of said bursts and being separated by an inter-train interval during which no electromagnetic pulses are delivered. 
     
     
         11 . The therapeutic or diagnostic device of  claim 10 , wherein each train has the same number of bursts, and wherein the inter-train interval is longer than the duration of each train. 
     
     
         12 . The therapeutic or diagnostic device of  claim 1 , wherein the neurological stimulation device comprises a transcranial magnetic stimulation (TMS) device configured to non-invasively stimulate the human subject's central or peripheral nervous system by repetitively emitting the electronic pulses in the form of a transient electromagnetic field generated from one or more energized coils. 
     
     
         13 . The therapeutic or diagnostic device of  claim 1 , wherein the neurological stimulation device comprises a device selected from the group of: a vagus nerve stimulation device, a peripheral nerve stimulation device, a deep brain stimulation device, a peripheral nerve field stimulation device, a cortical stimulation device, a transcutaneous vagal nerve stimulation device, a transcutaneous electrical nerve stimulation device, an electroconvulsive therapy device, a transcranial direct current stimulation device, a transcranial alternating current device, a transcranial random noise device, a trigeminal nerve stimulation device, or a paired associative stimulation device. 
     
     
         14 . The therapeutic or diagnostic device of  claim 1 , wherein the set of stored stimulation parameters further comprises a number of pulses per burst parameter, a number of bursts per train parameter, and one or more train length parameters, wherein each train comprises the same number of plurality of bursts. 
     
     
         15 . The therapeutic or diagnostic device of  claim 1 , wherein the set of stored stimulation parameters are entered via a user interface and are temporarily stored during a treatment session involving delivery of the electromagnetic pulses to the human subject, and are thereafter discarded. 
     
     
         16 . The therapeutic or diagnostic device of  claim 1 , wherein the set of stored stimulation parameters are selected so as to induce an inhibitory neural response in the human subject. 
     
     
         17 . The therapeutic or diagnostic device of  claim 1 , wherein the set of stored stimulation parameters are selected so as to induce an excitatory neural response in the human subject. 
     
     
         18 . The therapeutic or diagnostic device of  claim 1 , wherein the set of stored stimulation parameters are selected so as to augment the response to another central or peripheral nervous system treatment. 
     
     
         19 . The therapeutic or diagnostic device of  claim 1 , wherein the neurological stimulation device comprises:
 a pulse command generator responsive to the stimulation parameters for generating pulse commands according to the pulse frequency parameter and the burst repetition frequency parameter; and   a pulse delivery mechanism responsive to the pulse commands generated by the pulse command generator, for generating a central or peripheral nerve stimulating pulse corresponding to each pulse command.   
     
     
         20 . The therapeutic or diagnostic device of  claim 1 , wherein the pulse frequency parameter is stored as a time duration corresponding to the frequency represented by the pulse frequency parameter, and wherein the burst repetition frequency parameter is stored as a time duration corresponding to the frequency represented by the burst repetition frequency parameter. 
     
     
         21 . A therapeutic or diagnostic system comprising:
 a set of stored stimulation parameters determining a burst stimulation sequence, the set of stored stimulation parameters including at least a pulse frequency parameter selected in a range from 12 to 28 Hertz and a burst repetition frequency parameter having a value that is different than the pulse frequency parameter;   a pulse command generator responsive to the set of stored stimulation parameters, configured to output pulse commands with a pattern based upon the set of stored stimulation parameters including the pulse frequency parameter and the burst repetition frequency parameter; and   a non-invasive brain stimulation device response to the pulse commands, configured to stimulate the human subject's brain by repetitively emitting electromagnetic pulses according to the pattern of pulse commands, the electromagnetic pulses arranged in a plurality of bursts each comprising at least two electromagnetic pulses spaced according to the pulse frequency parameter, the bursts being spaced according to the burst repetition frequency parameter.   
     
     
         22 . The therapeutic or diagnostic system of  claim 21 , wherein the burst repetition frequency parameter is selected in a range from 3 to 8 Hertz. 
     
     
         23 . The therapeutic or diagnostic system of  claim 22 , wherein the pulse frequency parameter is selected in a range from 16 to 28 Hertz. 
     
     
         24 . The therapeutic or diagnostic system of  claim 23 , wherein the burst repetition frequency parameter is selected in a range from 4 to 7 Hertz. 
     
     
         25 . The therapeutic or diagnostic system of  claim 24 , wherein the burst repetition frequency parameter is selected in a range from 5 to 6 Hertz. 
     
     
         26 . The therapeutic or diagnostic system of  claim 23 , wherein the pulse frequency parameter is selected in a range from 19 to 21 Hertz. 
     
     
         27 . The therapeutic or diagnostic system of  claim 26 , wherein the burst repetition frequency parameter is selected in a range from 4 to 7 Hertz. 
     
     
         28 . The therapeutic or diagnostic system of  claim 27 , wherein the number of electromagnetic pulses per burst is three. 
     
     
         29 . The therapeutic or diagnostic system of  claim 27 , wherein the burst repetition frequency parameter is selected in a range from 5 to 6 Hertz. 
     
     
         30 . The therapeutic or diagnostic system of  claim 29 , wherein the number of electromagnetic pulses per burst is three. 
     
     
         31 . The therapeutic or diagnostic system of  claim 23 , wherein the pulse frequency parameter is selected in a range from 22 to 26 Hertz. 
     
     
         32 . The therapeutic or diagnostic system of  claim 31 , wherein the burst repetition frequency parameter is selected in a range from 4 to 7 Hertz. 
     
     
         33 . The therapeutic or diagnostic system of  claim 32 , wherein the number of electromagnetic pulses per burst is two. 
     
     
         34 . The therapeutic or diagnostic system of  claim 32 , wherein the burst repetition frequency parameter is selected in a range from 5 to 6 Hertz. 
     
     
         35 . The therapeutic or diagnostic system of  claim 34 , wherein the number of electromagnetic pulses per burst is two. 
     
     
         36 . The therapeutic or diagnostic system of  claim 21 , wherein the burst repetition frequency parameter is selected so that the ratio of the pulse frequency parameter to the burst repetition frequency parameter is in the range from 3 to 5. 
     
     
         37 . The therapeutic or diagnostic system of  claim 21 , wherein the bursts are arranged in a plurality of trains, each train comprising a plurality of said bursts and being separated by an inter-train interval during which no electromagnetic pulses are delivered. 
     
     
         38 . The therapeutic or diagnostic system of  claim 37 , wherein each train has the same number of bursts, and wherein the inter-train interval is longer than the duration of each train. 
     
     
         39 . The therapeutic or diagnostic system of  claim 21 , wherein the non-invasive brain stimulation device comprises a transcranial magnetic stimulation (TMS) device configured to stimulate the human subject's brain by repetitively emitting the electronic pulses in the form of a transient electromagnetic field generated from one or more energized coils. 
     
     
         40 . The therapeutic or diagnostic system of  claim 21 , wherein the set of stored stimulation parameters further comprises a number of pulses per burst parameter, a number of bursts per train parameter, and a train length parameter, wherein each train comprises the same number of plurality of bursts. 
     
     
         41 . The therapeutic or diagnostic system of  claim 21 , wherein the set of stored stimulation parameters are entered via a user interface and are temporarily stored during a treatment session involving delivery of the electromagnetic pulses to the human subject, and are thereafter discarded. 
     
     
         42 . The therapeutic or diagnostic system of  claim 21 , wherein the set of stored stimulation parameters are selected so as to induce an inhibitory neural response in the human subject. 
     
     
         43 . The therapeutic or diagnostic system of  claim 21 , wherein the set of stored stimulation parameters are selected so as to induce an excitatory neural response in the human subject. 
     
     
         44 . The therapeutic or diagnostic system of  claim 21 , wherein the set of stored stimulation parameters are selected so as to augment the response to another central or peripheral nervous system treatment. 
     
     
         45 . A therapeutic or diagnostic system comprising:
 a set of stored stimulation parameters determining a burst stimulation sequence, the set of stored stimulation parameters including at least a pulse frequency parameter selected in a range from 12 to 40 Hertz and a burst repetition frequency parameter having a value that is different than the pulse frequency parameter, wherein the burst repetition frequency parameter is selected so that the ratio of the pulse frequency parameter to the burst repetition frequency parameter is equal to or greater than three and less than five;   a pulse command generator responsive to the set of stored stimulation parameters, configured to output pulse commands with a pattern based upon the set of stored stimulation parameters including the pulse frequency parameter and the burst repetition frequency parameter; and   a non-invasive brain stimulation device response to the pulse commands, configured to stimulate the human subject's brain by repetitively emitting electromagnetic pulses according to the pattern of pulse commands, the electromagnetic pulses arranged in a plurality of bursts each comprising at least two electromagnetic pulses spaced according to the pulse frequency parameter, the bursts being spaced according to the burst repetition frequency parameter.