Abstract: The present disclosure relates to methods, devices and systems used for the treatment of neurological disorders via stimulation of the superficial elements of the trigeminal nerve (“TNS”). More specifically, minimally invasive methods of stimulation of the superficial branches of the trigeminal nerve located extracranially in the face, namely the supraorbital, supratrochlear, infratrochlear, auriculotermporal, zygomaticotemporal, zygomaticoorbital, zygomaticofacial, nasal, infraorbital, and mentalis nerves (also referred to collectively as the superficial trigeminal nerve) are disclosed herein. Systems and devices configured for therapeutic stimulation of the branches of the trigeminal nerves, such as the superficial trigeminal nerve, and their methods of application are also described.

Abstract: Trigeminal nerves are stimulated based upon pulse counting and chronobiology. A cutaneous electrode assembly is applied to the forehead to stimulate the ophthalmic nerves. A method may include determining a number of pulses to be administered to a patient based upon the disorder being treated, and pulsing current through an electrode assembly to stimulate the patient's supraorbital and supratrochlear nerves with the determined number of pulses. Another method may include determining a pulse repetition frequency for pulses to be administered to a patient based upon the disorder being treated, and pulsing current through an electrode assembly to stimulate the patient's supraorbital and supratrochlear nerves at the pulse repetition frequency.

Abstract: A windowed electrode assembly includes a foam layer having windows. Each window receives a corresponding gel pad that is sized such that it is contained by the window's sidewalls. The windowed electrode assembly includes a foam backing layer that forms a back wall for the windows such that each gel pad is encased by the window's sidewalls and back wall.

Abstract: The present disclosure relates to methods, devices and systems used for the treatment of neurological disorders via stimulation of the superficial elements of the trigeminal nerve (“TNS”). More specifically, minimally invasive methods of stimulation of the superficial branches of the trigeminal nerve located extracranially in the face, namely the supraorbital, supratrochlear, infratrochlear, auriculotemporal, zygomaticotemporal, zygomaticoorbital, zygomaticofacial, nasal, infraorbital, and mentalis nerves (also referred to collectively as the superficial trigeminal nerve) are disclosed herein. Systems and devices configured for therapeutic stimulation of the branches of the trigeminal nerves, such as the superficial trigeminal nerve, and their methods of application are also described.

Abstract: The present disclosure relates to methods, devices, and systems used for the treatment of mood, anxiety, cognitive, and behavioral disorders (collectively, neuropsychiatric disorders) via stimulation of the superficial elements of the trigeminal nerve (“TNS”). More specifically, minimally invasive systems, devices and methods of stimulation of the superficial branches of the trigeminal nerve located extracranially in the face, namely the supraorbital, supratrochlear, infraorbital, auriculotemporal, zygomaticotemporal, zygomaticoorbital, zygomaticofacial, nasal and mentalis nerves (also referred to collectively as the superficial trigeminal nerve) are disclosed herein.

Abstract: An implantable subcutaneous electrode system is disclosed. The implantable subcutaneous electrode system may include an electrode body with electrical contacts disposed thereon or integrally formed therein. The electrode body also may include an insulation region defined between the electrical contacts and an aperture defined in the electrode body for receiving an anchoring device. A minimally invasive delivery device and methods for delivery of an implantable electrode system is also provided. The methods may include steps of introducing a needle comprising a cannula and a stylet through a patient's skin, removing the stylet while leaving the cannula in place, introducing an electrode applicator through the cannula, the electrode applicator comprising a hollow driver which receives the electrode assembly, and anchoring the electrode assembly to a bone by driving the hollow driver such that a self-tapping screw within the electrode assembly screws into the bone.

Abstract: A system for trigeminal nerve stimulation includes a pulse generator, which includes a user control configured to receive a user adjustment and a microcontroller configured to receive electric stimulation parameters and operate the pulse generator to produce electrical pulses according to the electric stimulation parameters during a treatment session. A method for nerve stimulation includes receiving, by a pulse generator, electric stimulation parameters, and producing, by the pulse generator, electrical pulses according to electric stimulation parameters during a treatment session. The electric stimulation parameters include at least one user-set parameter, which includes a current amplitude that is responsive to the user adjustment of the user control, and at least one physician-set parameter, which includes an upper bound and a lower bound for the current amplitude.

Abstract: The present disclosure relates to methods, devices and systems used for the treatment of medical disorders via stimulation of the superficial elements of the trigeminal nerve. More specifically, minimally invasive systems, devices and methods of stimulation of the superficial branches of the trigeminal nerve located extracranially in the face, namely the supraorbital, supratrochlear, infraorbital, auriculotemporal, zygomaticotemporal, zygomaticoorbital, zygomaticofacial, nasal and mentalis nerves (also referred to collectively as the superficial trigeminal nerve) are disclosed herein.

Abstract: Cutaneous and subcutaneous TNS embodiments are disclosed for addressing autonomic nervous system imbalances. A cutaneous electrode assembly is applied to a patient's forehead, and a current is pulsed through the electrode assembly to stimulate the supraorbital and supratrochlear nerves on the patient to increase activity for the patient's parasympathetic nervous system. Pulsing the current increases the power spectral density for the patient's heart rate variability in a 0.1 to 0.15 Hz frequency band.

Abstract: A windowed electrode assembly includes a foam layer having windows. Each window receives a corresponding gel pad that is sized such that it is contained by the window's sidewalls. The windowed electrode assembly includes a foam backing layer that forms a back wall for the windows such that each gel pad is encased by the window's sidewalls and back wall.

Abstract: The present disclosure relates to methods, devices, and systems used for the treatment of mood, anxiety, cognitive, and behavioral disorders (collectively, neuropsychiatric disorders) via stimulation of the superficial elements of the trigeminal nerve (“TNS”). More specifically, minimally invasive systems, devices and methods of stimulation of the superficial branches of the trigeminal nerve located extracranially in the face, namely the supraorbital, supratrochlear, infraorbital, auriculotemporal, zygomaticotemporal, zygomaticoorbital, zygomaticofacial, nasal and mentalis nerves (also referred to collectively as the superficial trigeminal nerve) are disclosed herein.

Abstract: The present disclosure relates to methods, devices, and systems used for the treatment of mood, anxiety, cognitive, and behavioral disorders (collectively, neuropsychiatric disorders) via stimulation of the superficial elements of the trigeminal nerve (“TNS”). More specifically, minimally invasive systems, devices and methods of stimulation of the superficial branches of the trigeminal nerve located extracranially in the face, namely the supraorbital, supratrochlear, infraorbital, auriculotemporal, zygomaticotemporal, zygomaticoorbital, zygomaticofacial, nasal and mentalis nerves (also referred to collectively as the superficial trigeminal nerve) are disclosed herein.

Abstract: A system for trigeminal nerve stimulation includes a pulse generator, which includes a user control configured to receive a user adjustment and a microcontroller configured to receive electric stimulation parameters and operate the pulse generator to produce electrical pulses according to the electric stimulation parameters during a treatment session. A method for nerve stimulation includes receiving, by a pulse generator, electric stimulation parameters, and producing, by the pulse generator, electrical pulses according to electric stimulation parameters during a treatment session. The electric stimulation parameters include at least one user-set parameter, which includes a current amplitude that is responsive to the user adjustment of the user control, and at least one physician-set parameter, which includes an upper bound and a lower bound for the current amplitude.

Abstract: The present disclosure relates to methods, devices and systems used for the treatment of neurological disorders via stimulation of the superficial elements of the trigeminal nerve (“TNS”). More specifically, minimally invasive methods of stimulation of the superficial branches of the trigeminal nerve located extracranially in the face, namely the supraorbital, supratrochlear, infratrochlear, auriculotemporal, zygomaticotemporal, zygomaticoorbital, zygomaticofacial, nasal, infraorbital, and mentalis nerves (also referred to collectively as the superficial trigeminal nerve) are disclosed herein. Systems and devices configured for therapeutic stimulation of the branches of the trigeminal nerves, such as the superficial trigeminal nerve, and their methods of application are also described.

Abstract: The present disclosure relates to methods, devices, and systems used for the treatment of mood, anxiety, cognitive, and behavioral disorders (collectively, neuropsychiatric disorders) via stimulation of the superficial elements of the trigeminal nerve (“TNS”). More specifically, minimally invasive systems, devices and methods of stimulation of the superficial branches of the trigeminal nerve located extracranially in the face, namely the supraorbital, supratrochlear, infraorbital, auriculotemporal, zygomaticotemporal, zygomaticoorbital, zygomaticofacial, nasal and mentalis nerves (also referred to collectively as the superficial trigeminal nerve) are disclosed herein.

Abstract: Disclosed herein is a system for trigeminal nerve stimulation. In one embodiment, the system includes a storage medium, a pulse generator in communication with the storage medium, a power source coupled to the pulse generator, and at least one electrode communicatively coupled to the pulse generator. The pulse generator includes a microcontroller which executes instructions from the storage medium and the microcontroller is configured to perform at least one of the following operations: produce electrical pulses having defined characteristics, record a log of use and anomalous events, restrict use to a specified individual, interface with electrodes, provide a signal to the specified individual indicating operational conditions and trouble conditions, and provide a signal to the specified individual indicating an end of a treatment period.

Abstract: Disclosed herein are methods for identifying and targeting autonomic and autonomic-related brain regions. In one embodiment, a method of identifying a brain region in a patient comprises administering to the patient a targeting agent that activates or inhibits a brain region and imaging the brain region.

Abstract: The present disclosure relates to methods, devices, and systems used for the treatment of mood, anxiety, cognitive, and behavioral disorders (collectively, neuropsychiatric disorders) via stimulation of the superficial elements of the trigeminal nerve (“TNS”). More specifically, minimally invasive systems, devices and methods of stimulation of the superficial branches of the trigeminal nerve located extracranially in the face, namely the supraorbital, supratrochlear, infraorbital, auriculotemporal, zygomaticotemporal, zygomaticoorbital, zygomaticofacial, nasal and mentalis nerves (also referred to collectively as the superficial trigeminal nerve) are disclosed herein.

Abstract: The present disclosure relates to methods, devices and systems used for the treatment of neurological disorders via stimulation of the superficial elements of the trigeminal nerve (“TNS”). More specifically, minimally invasive methods of stimulation of the superficial branches of the trigeminal nerve located extracranially in the face, namely the supraorbital, supratrochlear, infratrochlear, auriculotemporal, zygomaticotemporal, zygomaticoorbital, zygomaticofacial, nasal, infraorbital, and mentalis nerves (also referred to collectively as the superficial trigeminal nerve) are disclosed herein. Systems and devices configured for therapeutic stimulation of the branches of the trigeminal nerves, such as the superficial trigeminal nerve, and their methods of application are also described.

Abstract: Disclosed herein are methods for identifying and targeting autonomic and autonomic-related brain regions. In one embodiment, a method of identifying a brain region in a patient comprises administering to the patient a targeting agent that activates or inhibits a brain region and imaging the brain region.