Abstract: Vagal nerve stimulation devices and methods are provided for treating medical conditions, such as conditions associated with insufficient dopamine and/or endogenous opioids in the brain. A device includes one or more electrodes having a contact surface for contacting an outer skin surface of a patient and an energy source coupled to the electrodes. The energy source generates one or more electrical impulses and transmits the electrical impulses to the electrodes and transcutaneously through the outer skin surface of the patient at or near a vagus nerve. The one or more electrical impulses is sufficient to modulate the vagus nerve and release dopamine and/or endogenous opioids in a brain of the patient.

Abstract: Devices and methods are described to produce therapeutic effects in a patient by utilizing an energy source that transmits energy non-invasively to nervous tissue. A device for modulating a nerve within a body of a patient comprises a housing comprising a power supply and a signal generator for generating an electrical impulse. The electrical impulse comprises bursts of 2 to 20 pulses, wherein each of the bursts has a frequency of 15 to 50 Hz. The device further comprises first and second electrodes coupled to the housing and having a contact surface configured for contacting an outer skin surface of a neck of a user. The energy source is configured to transmit the electrical impulse from the first and second electrodes through the outer skin surface of the user to a vagus nerve.

Abstract: Methods for treating medical disorders, such as migraine or other primary headaches, or fibromyalgia, by electrical stimulation of a nerve. The method comprises applying a first stimulus to a patient having a medical condition and measuring a first baseline physiological response from the patient. An electrical impulse is applied to a nerve within the patient and second stimulus is applied to the patient. A second physiological response evoked by the second stimulus is measured and compared to the first baseline physiological response. The methods may be used to optimize the placement of a stimulator, to test whether a patient is a suitable candidate for treatment using nerve stimulation, and/or to select the stimulation parameters that optimize acute or chronic treatment.

Abstract: Devices and methods are disclosed for treating one or more symptoms of a central nervous system disorder in a patient, such as fibromyalgia, anxiety, traumatic brain injury or post-traumatic stress disorder (PTSD). A device comprises one or more electrodes configured for contacting an outer skin surface of the patient and an energy source coupled to the electrodes. The energy source generates at least one electrical impulse and transmits the electrical impulse transcutaneously from the electrodes through the outer skin surface of the patient to a vagus nerve in the patient. The electrical impulse comprises a burst period and a constant period. Each burst period comprises 2 to 20 pulses that alternate between a positive and negative electric field charge and at least a portion of each constant period comprises zero pulses. The electrical impulse is sufficient to modify the vagus nerve such that the symptoms of the disorder are reduced.

Abstract: Systems and methods are provided for treating an inflammatory or allergic response associated with a replicating pathogen, such as a virus in the coronaviridae family. The methods include emitting an electrical impulse near a vagus nerve within the patient sufficient to inhibit or reduce an inflammatory or allergic response in the patient, provide relief for bronchoconstriction that results in the tightening of airways and the inability to breath without ventilator support and/or lessen the abnormal blot clotting that develops in some patients. The systems and methods are particularly useful for treating post-COVID conditions or post-acute sequelae of COVID-19 that develop in “long-haul” or COVID patients.

Abstract: Methods and devices are provided for the non-invasive treatment of diseases or disorders, such as Alzheimer's disease, Parkinson's disease, rheumatoid arthritis (RA), multiple sclerosis, postoperative cognitive dysfunction, or postoperative delirium. A method for comprises positioning an electrode in contact with an outer skin surface of a neck of the patient and transmitting, via the electrode, an electric current transcutaneously and non-invasively through the outer skin surface of the neck of the patient to generate an electrical impulse at or near a vagus nerve within the patient. The electrical impulse comprises bursts of 2 to 20 pulses with each of the bursts comprising a frequency from about 15 Hz to about 50 Hz and with each of the pulses comprising a duration from about 20 microseconds to about 1000 microseconds.

Abstract: Devices, systems and methods are disclosed for treating one or more symptoms of a central nervous system disorder in a patient, such as fibromyalgia, anxiety, traumatic brain injury or post-traumatic stress disorder (PTSD). A device comprises one or more electrodes configured for contacting an outer skin surface of the patient and an energy source coupled to the electrodes. The energy source generates at least one electrical impulse and transmits the at least one electrical impulse transcutaneously from the electrodes through the outer skin surface of the patient to a vagus nerve in the patient for about ninety seconds to about 3 minutes. The electrical impulse is sufficient to modify the vagus nerve such that the symptoms of the disorder are reduced.

Abstract: Devices, systems and methods are disclosed for treating one or more symptoms of central nervous system disorders in a patient, such as anxiety disorders, fibromyalgia, traumatic brain injury, PTSD, and others. A method includes positioning a contact surface of a device in contact with an outer skin surface of patient and applying an electrical impulse transcutaneously from the device through the outer skin surface of the patient to a vagus nerve in the patient for about 90 seconds to about 3 minutes. The electrical impulse is sufficient to modify the vagus nerve such that the symptoms of the central nervous system disorder are reduced. For chronic treatment of such disorders, a stimulation protocol is provided that includes two or more doses administered per day for a period of time sufficient to relieve the symptoms.

Abstract: Devices, systems and methods are disclosed that allow a patient to self-treat a medical condition, such as headache, by noninvasive stimulation of a nerve. A system comprises a stimulator having an interface configured to contact an outer skin surface of a patient and an energy source coupled to the interface. The energy source transmits an electrical impulse through the interface transcutaneously through the outer skin surface of the patient to a nerve of the patient such that the nerve is modulated. The system further comprises a mobile device coupled to the stimulator to transmit data to the stimulator. The data includes a therapy regimen to reduce one or more symptoms of a headache in the patient.

Abstract: Systems and methods for remote therapy and patient monitoring are provided. A method comprises contacting an outer skin surface of a patient with a contact surface of a stimulator and transmitting an electrical impulse from the stimulator transcutaneously through the outer skin surface to a nerve within the patient. Data related to parameters of the electrical impulse applied to the nerve is stored and transmitted to a remote source. The data may include duration of treatment, amplitude of the electrical impulse, compliance with a prescribed therapy regimen or other relevant data related to the therapy. The method may further include collecting patient status data, such as symptoms of a medical condition (e.g., severity of a headache) before, during and/or after stimulation. The patient status data is correlated with the treatment data to monitor compliance and/or the effectiveness of the therapy.

Abstract: Systems and methods are disclosed that allow a patient to self-treat a medical condition, such as migraine headache and trigeminal neuralgia and the like. The system comprises a stimulator configured for wireless coupling to a mobile device and comprising a signal generator that generates an electrical impulse and an energy source. The stimulator includes a contact surface configured to contact an outer skin surface of a head of a patient and a user interface for selecting a therapy regimen. The stimulator transmits the electrical impulse transcutaneously through the outer skin surface to a nerve at a target region of the head, wherein the electrical impulse is sufficient to modulate the nerve and modify the medical condition. The system further comprises a software program downloadable onto the mobile device and configured to communicate with the stimulator.

Abstract: Systems and methods are provided for delivering energy impulses (and/or fields) to bodily tissues. In certain aspects, the systems and methods are particularly useful for temporarily or permanently improving intelligence, learning capacity, memory retention, recall, mood, alertness and/or sleep efficiency in human beings. In certain embodiments, the methods and devices enhance neurostructural development over a period of time by increasing neurogenesis, neuronal plasticity and/or neural connectivity efficiency, and/or by improving the chemical microenvironment of the evolving neural network. In some embodiments, these enhancements may provide temporary improvement to enable an individual to, for example, accomplish a particular task while under duress, sleep deprivation, stress, anxiety or the like. In other embodiments, these changes permanently enhance the intelligence, emotional stability, and overall brain health of the treated individual.

Abstract: Systems and methods are provided for treating an inflammatory or allergic response associated with a replicating pathogen, such as a virus in the coronaviridae family. The methods include emitting an electrical impulse near a vagus nerve within the patient sufficient to inhibit or reduce an inflammatory or allergic response in the patient, provide relief for bronchoconstriction that results in the tightening of airways and the inability to breath without ventilator support and/or lessen the abnormal blot clotting that develops in some patients. The systems and methods are particularly useful for treating post-COVID conditions or post-acute sequelae of COVID-19 that develop in “long-haul” or COVID patients.

Abstract: Devices, systems and methods are disclosed for treating one or more symptoms of post-traumatic stress disorder (PTSD) in a patient. A method includes positioning a contact surface of a device in contact with an outer skin surface of patient and applying an electrical impulse transcutaneously from the device through the outer skin surface of the patient to a vagus nerve in the patient for about 90 seconds to about 3 minutes. The electrical impulse is sufficient to modify the vagus nerve such that the symptoms of PTSD are reduced. For chronic treatment of PTSD, a stimulation protocol is provided that includes two or more doses administered per day for a period of time sufficient to relieve the symptoms.

Abstract: Systems and methods for remote therapy and patient monitoring are provided. A method comprises contacting an outer skin surface of a patient with a contact surface of a stimulator and transmitting an electrical impulse from the stimulator transcutaneously through the outer skin surface to a nerve within the patient. Data related to parameters of the electrical impulse applied to the nerve is stored and transmitted to a remote source. The data may include duration of treatment, amplitude of the electrical impulse, compliance with a prescribed therapy regimen or other relevant data related to the therapy. The method may further include collecting patient status data, such as symptoms of a medical condition (e.g., severity of a headache) before, during and/or after stimulation. The patient status data is correlated with the treatment data to monitor compliance and/or the effectiveness of the therapy.

Abstract: Devices, systems and methods are provided for treating various symptoms, disorders and medical conditions through noninvasive stimulation of a nerve. A system comprises a stimulator including an electrode configured to contact an outer skin surface of a patient and a user interface for turning the stimulator ON to enable the stimulator to operate. An energy source is coupled to the stimulator to generate an electrical impulse, wherein the stimulator transmits the electrical impulse from the electrode transcutaneously through an outer skin surface of an individual to a selected nerve within the individual. The system further comprises a software application coupled to the stimulator and configured to transmit data to the stimulator. The data may include authorization for the stimulator to transmit the electrical impulse.

Abstract: Systems and methods are provided for delivering energy impulses (and/or fields) to bodily tissues. In certain aspects, the systems and methods are particularly useful for temporarily or permanently improving intelligence, learning capacity, memory retention, recall, mood, alertness and/or sleep efficiency in human beings. In certain embodiments, the methods and devices enhance neurostructural development over a period of time by increasing neurogenesis, neuronal plasticity and/or neural connectivity efficiency, and/or by improving the chemical microenvironment of the evolving neural network. In some embodiments, these enhancements may provide temporary improvement to enable an individual to, for example, accomplish a particular task while under duress, sleep deprivation, stress, anxiety or the like. In other embodiments, these changes permanently enhance the intelligence, emotional stability, and overall brain health of the treated individual.

Abstract: Devices, systems and methods are disclosed for treating symptoms of a user, such as anxiety, depression and/or epileptic seizures, by electrical non-invasive stimulation of a nerve, such as the vagus nerve. A stimulator has a contact surface for contacting an outer skin surface of a patient. The stimulator is configured to wirelessly receive a signal from the software application that includes an electrical stimulation signal comprising at least one electrical impulse sufficient to modulate a nerve within a patient and to ameliorate one or more symptoms in the patient. The stimulator is configured to transmit the electrical impulse through the contact surface and the outer skin surface of the user.

Abstract: Systems and methods are disclosed that allow a patient to self-treat a medical condition, such as migraine headache and trigeminal neuralgia and the like, by noninvasive electrical stimulation of nerves of the head, particularly supraorbital, supratrochlear, infraorbital, and mental nerves in the vicinity of their foramen or notch. The system comprises a stimulator having one or more electrodes that apply electrical impulses transcutaneously through the patient's skin to the targeted nerve. The stimulator may be coupled to a handheld mobile device, such as a smartphone, for receiving a treatment regimen to treat the medical condition. The system is designed to address problems that arise particularly during self-treatment, when a medical professional is not present.

Abstract: Devices, systems and methods are disclosed for electrical stimulation of nerves to treat one or more symptoms in a user. The methods comprise transcutaneously transmitting electrical impulses to the nerve according to a treatment paradigm. The treatment paradigm may include generating and transmitting the electrical impulse as a single dose from about 30 seconds to about 5 minutes. The treatment paradigm may comprise a treatment session of 2 to 4 times within an hour time period and/or as a single dose from 2 to 5 times during a day.