Systems, devices and methods for the treatment of neurological disorders and conditions

Abstract

The present disclosure relates to methods, devices, and systems used for the treatment of and/or promoting recovery from various neurological disorders and conditions, including epilepsy and other seizure disorders and movement and other related disorders; for promoting recovery from acute or chronic brain injury (e.g. stroke, hypoxia/ischemia, head trauma, subarachnoid hemorrhage, and other forms of brain injury, for awakening and/or promoting the recovery of patients in various levels of coma, altered mental status or vegetative state); or for promoting recovery from chronic daily headache and migraine and related disorders via external (cutaneous) stimulation of the sensory branches of the trigeminal nerve in the face and forehead. More specifically, devices and electrode assemblies configured for stimulation of the supraorbital, supratrochlear, infraorbital, auriculotemporal, zygomaticotemporal, zygomaticoorbital, zygomaticofacial, nasal and infratrochlear nerves are disclosed.

What is claimed is: 
     
         1 . A system for trigeminal nerve stimulation for treatment of a neurological disorder or condition, the system comprising:
 a pulse generator; and   a cutaneous electrode assembly in electrical communication with the pulse generator, the assembly comprising:
 a first electrode comprising at least one contact configured for cutaneous placement over an ophthalmic nerve on one side of a patient's forehead; 
 a second electrode comprising at least one contact configured for cutaneous placement over an ophthalmic nerve on an opposing side of the patient's forehead; and 
 an insulating region surrounding each of the first and second electrodes. 
   
     
     
         2 . The system of  claim 1 , further comprising a wire operably connecting the pulse generator and the cutaneous electrode assembly. 
     
     
         3 . The system of  claim 1 , further comprising a regulating device configured to regulate a maximum charge balanced output current below approximately 30-50 mA. 
     
     
         4 . The system of  claim 1 , wherein the neurological disorder or condition is selected from the group consisting of: epilepsy, seizure related disorders, acute brain injury, chronic brain injury, chronic daily headache, migraine, disorders related to migraine and headache and movement disorders. 
     
     
         5 . The system of  claim 1 , wherein the pulse generator is configured to apply electrical signals at a frequency between approximately 20 and 300 Hertz, at a pulse duration between approximately 50 and 500 microseconds, at an output current density of not greater than approximately 25 mA/cm 2  and an output charge density of not greater than approximately 10 microCoulomb/cm 2  at the cerebral cortex. 
     
     
         6 . A method for treating a neurological disorder or condition by trigeminal nerve stimulation, comprising:
 aligning a cutaneous electrode assembly with the nasal midline of a patient, wherein the cutaneous electrode assembly includes a first contact separated from a second contact by an expected separation between the ophthalmic nerves on the patient's forehead;   applying the aligned cutaneous electrode assembly on the patient's forehead such that the first contact overlays a first one of the ophthalmic nerves and the second contact overlays a remaining second one of the ophthalmic nerves on the patient's forehead; and   driving electrical signals through the applied cutaneous electrode assembly to treat the neurological disorder or condition.   
     
     
         7 . The method of  claim 6 , wherein the step of driving electrical signals comprises driving electrical signals at a frequency between approximately 20 and 300 Hertz, at a current of 0.05 to 5 milliamperes (mA) and at a pulse duration of less than or equal to 500 microseconds. 
     
     
         8 . The method of  claim 6 , wherein the step of driving electrical signals comprises driving electrical signals at a frequency between approximately 20 and 300 Hertz, at a pulse duration between approximately 50 and 500 microseconds, at an output current density of not greater than approximately 25 mA/cm 2  and an output charge density of not greater than approximately 10 microCoulomb/cm 2  at the cerebral cortex. 
     
     
         9 . The method of  claim 6 , wherein the neurological disorder or condition is selected from the group consisting of: epilepsy, seizure related disorders, acute brain injury, chronic brain injury, chronic daily headache, migraine, disorders related to migraine and headache and movement disorders.