Devices and methods for treating stress and improving alertness using electrical stimulation

Abstract

In an illustrative embodiment, systems and methods for treating stress and/or for improving alertness in a subject using neurostimulation therapy include placing first electrode(s) on, over, or adjacent to an auricular branch of the vagus nerve, placing second electrode(s) on, over or adjacent to an auriculotemporal nerve, and delivering therapeutic stimulation pulses via the first electrode(s) and the second electrode(s) by delivering a first series of stimulation pulses to the first electrode(s), the first series configured to increase activity in neural medullary structure(s), and delivering a second series of stimulation pulses to the second electrode(s), the second series configured to increase activity in neural structures within the Trigeminocervical Complex.

1 . A method for mitigating stress and/or improving performance in stressful situations while reducing the likelihood of and/or controlling bleeding by applying neural stimulations, the method comprising:
 placing at least one first electrode on, over, or adjacent to a first neural structure of a set of neural structures in or around the auricle, wherein each electrode of the at least one first electrode is placed against or at least partially into a respective tissue region on or surrounding an ear of a subject;   placing at least one second electrode on, over or adjacent to a second neural structure of the set of neural structures, wherein each electrode of the at least one second electrode is placed against or at least partially into a respective tissue region on or surrounding the ear of the subject; and   intermittently activating a wearable neural stimulation device comprising the at least one first electrode and at least one second electrode, wherein the wearable neural stimulation device is continuously worn by the subject for a period of time comprising multiple therapy delivery periods and activated to deliver an electrical stimulation therapy to the subject prior to and/or during periods of subject activity involving one or more stressors to the subject, wherein
 intermittently activating comprises repeatedly activating delivery of the electrical stimulation therapy, by the wearable neural stimulation device, for a therapy delivery period of at least five minutes followed by a deactivation period, and 
 delivering the electrical stimulation therapy comprises
 delivering, via a controller,
 a first series of neural pathway stimulation pulses at one or more frequencies within a range from 5 Hz to 30 Hz to the at least one first electrode, and 
 delivering a second series of neural pathway stimulation pulses at one or more frequencies within a range from 70 Hz to 150 Hz to the at least one second electrode; 
 
 
   wherein at least one electrode of the at least one first electrode is different than at least one electrode of the at least one second electrode.   
     
     
         2 .- 3 . (canceled) 
     
     
         4 . The method of  claim 1 , wherein the at least one first electrode and the at least one second electrode are percutaneous electrodes. 
     
     
         5 . (canceled) 
     
     
         6 . The method of  claim 1 , wherein the second series of neural pathway stimulation pulses is configured to increase responsiveness to sensory inputs of the subject under stress. 
     
     
         7 .- 8 . (canceled) 
     
     
         9 . The method of  claim 6 , wherein:
 the subject is an athlete performing in an athletic event.   
     
     
         10 . (canceled) 
     
     
         11 . The method of  claim 1 , wherein the second series of neural pathway stimulation pulses is configured to promote wakefulness, promote alertness, and/or mitigate fatigue in the subject. 
     
     
         12 . (canceled) 
     
     
         13 . The method of  claim 11 , wherein fatigue comprises fatigue derived from stress and/or from lack of adequate sleep. 
     
     
         14 .- 29 . (canceled) 
     
     
         30 . A system for mitigating stress and/or improving performance in stressful situations while reducing the likelihood of and/or controlling bleeding by applying transcutaneous stimulation using an ear-mounted stimulation device, the system comprising:
 an ear-mounted stimulation device comprising
 a plurality of electrodes each configured to deliver a non-piercing electrical stimulation via tissue, 
 an in-ear portion configured to be positioned against tissue portions of an inside of an ear of a wearer, the in-ear portion comprising a first portion of the plurality of electrodes, and 
 an earpiece portion configured to be positioned over the ear of the wearer in contact with tissue portions of an exterior of the ear of the wearer, the earpiece portion comprising a second portion of the plurality of electrodes; and 
 a controller in electrical communication with the ear-mounted stimulation device, wherein the controller comprises processing circuitry configured to deliver therapeutic stimulation pulses via the ear-mounted stimulation device, wherein the ear-mounted stimulation device is continuously worn by the wearer for a period of time comprising multiple therapy delivery periods and intermittently activated to deliver an electrical stimulation therapy to the wearer during periods of wearer activity involving one or more stressors in the wearer, to mitigate stress and/or improve performance in stressful situations, wherein
 intermittently activating comprises repeatedly activating delivery of the therapeutic stimulation pulses for a therapy delivery period of at least five minutes followed by a deactivation period, and 
 delivering the electrical stimulation therapy comprises
 delivering a first series of neural pathway stimulation pulses to at least one first electrode of the plurality of electrodes of the ear-mounted stimulation device at one or more frequencies within a range from 5 Hz to 30 Hz, 
 delivering a second series of neural pathway stimulation pulses at one or more frequencies within a range from 70 Hz to 150 Hz to at least one second electrode of the plurality of electrodes of the ear-mounted stimulation device, wherein 
  at least one electrode of the at least one first electrode is different than at least one electrode of the at least one second electrode. 
 
 
   
     
     
         31 .- 32 . (canceled) 
     
     
         33 . The system of  claim 30 , wherein each electrode of the first portion of electrodes is disposed, when the ear-mounted stimulation device is worn by the wearer, in a respective position against respective tissue of a concha, cavum, or a tragus of the ear. 
     
     
         34 . The system of  claim 30 , wherein each electrode of the second portion of electrodes is disposed, when the ear-mounted stimulation device is worn by the wearer, in a respective position against respective tissue of the external portion of the ear or respective tissue surrounding the external portion of the ear. 
     
     
         35 . The system of  claim 30 , wherein the earpiece portion is in wired electrical communication with the in-ear portion. 
     
     
         36 . The system of  claim 30 , wherein the therapeutic stimulation pulses are delivered via the ear-mounted stimulation device to mitigate stress including acute stress, Acute Stress Reaction, Combat Stress Reaction, and/or Operational Stress Reaction. 
     
     
         37 . The system of  claim 30 , wherein the ear-mounted stimulation device is intermittently activated to control stress, thereby mitigating symptoms leading to chronic stress. 
     
     
         38 . The system of  claim 30 , wherein the second series of neural pathway stimulation pulses is configured for mitigating tunnel vision. 
     
     
         39 . The system of  claim 30 , wherein the second series of neural pathway stimulation pulses is configured for increasing responsiveness to sensory inputs, increasing emotional reactivity, and/or increasing cognitive processing of the wearer under stress. 
     
     
         40 .- 41 . (canceled) 
     
     
         42 . The system of  claim 39 , wherein:
 the wearer is an athlete performing in an athletic event.   
     
     
         43 . (canceled) 
     
     
         44 . The system of  claim 30 , wherein the therapeutic stimulation pulses are delivered via the ear-mounted stimulation device to mitigate symptoms of burnout. 
     
     
         45 . The system of  claim 30 , wherein the second series of neural pathway stimulation pulses is configured for promoting wakefulness, promoting alertness, and/or mitigating fatigue. 
     
     
         46 . The system of  claim 45 , wherein mitigating fatigue comprises mitigating fatigue derived from stress and/or from lack of adequate sleep. 
     
     
         47 .- 53 . (canceled) 
     
     
         54 . The method of  claim 1 , wherein intermittently activating comprises activating based at least in part on feedback obtained from one or more sensors monitoring the subject. 
     
     
         55 . The method of  claim 54 , wherein the one or more sensors are configured to monitor at least one of electrodermal activity, neurological activity, or cardio-pulmonary activity. 
     
     
         56 . The method of  claim 54 , wherein the wearable neural stimulation device comprises the one or more sensors. 
     
     
         57 . The method of  claim 54 , wherein intermittently activating comprises deactivating based at least in part on subsequent feedback obtained from the one or more sensors being indicative of reduction or cessation of one or more symptoms.