Abstract: Devices and methods for the non-invasive stimulation of nerves, such as the vagus nerve, include a housing and an electrode coupled to the housing. The electrode is configured to be positioned adjacent to, or in contact with, an outer skin surface of a patient. A source of energy is coupled to the housing and operably coupled to the electrode. The source of energy emits an electrical impulse to the electrode such that the electrical impulse passes through the outer skin surface of the patient to a nerve at a target region in the patient sufficient to modulate the nerve.

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 device comprises a stimulator having an electrode configured for contacting an outer skin surface of a neck of the patient and an energy source configured to transmit, 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: 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 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: Devices and methods for the non-invasive stimulation of nerves, such as the vagus nerve, include a housing and an electrode coupled to the housing. The electrode is configured to be positioned adjacent to, or in contact with, an outer skin surface of a patient. A source of energy is coupled to the housing and operably coupled to the electrode. The source of energy emits an electrical impulse to the electrode such that the electrical impulse passes through the outer skin surface of the patient to a nerve at a target region in the patient sufficient to modulate the nerve. The electrical impulse comprises burst periods and constant periods, wherein each burst period includes 2 to 20 pulses and has a duration of less than 20,000 microseconds.

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 or preventing a developmental disorder, such as attention-deficit hyperactivity disorder (ADHD), an autism spectrum disorder, Asperger syndrome, childhood disintegrative disorder, overactive disorder, pervasive developmental disorder. A device comprises an electrode having a contact surface for contacting an outer skin surface of a patient and a power source coupled the electrode. The power source generates and transmits an electrical impulse having a frequency of about 1 kHz to about 20 kHz through the contact surface and the outer skin surface to a nerve within the patient. The electrical impulse is sufficient to modify the behavioral disorder in the patient.

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: Vagal nerve stimulation devices and methods are provided herein. A device comprises 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 pulses comprise bursts of 2 to 20 pulses within each burst with each burst having a frequency of about 5 Hz to about 100 Hz.

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 stimulus to a patient having a medical condition and measuring a baseline physiological response from the patient. An electrical impulse is applied to a nerve within the patient and the response evoked by the electrical impulse 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, systems, and methods are provided for treating various symptoms, disorders and medical conditions through noninvasive stimulation of a nerve. A system comprises a stimulator having an interface configured to contact an outer skin surface of a user and an energy source coupled to the interface. The energy source transmits an electrical signal comprising a plurality of electrical impulses through the interface transcutaneously through the outer skin surface of the user to a nerve of the user such that the nerve is modulated. The system further comprises a downloadable software application downloadable onto a mobile device configured for wireless coupling to the stimulator to transmit data from the software application to the stimulator. The downloadable software application controls a duration of time in which the stimulator generates the electrical signal.

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.