Devices, systems and methods for the treatment of neurological disorders and neuropsychiatric disorders

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, as well as for the treatment of mood, anxiety, post traumatic stress disorder, and cognitive and behavioral disorders (collectively, neuropsychiatric disorders) via stimulation of the superficial elements of the trigeminal nerve.

1 - 8 . (canceled) 
     
     
         9 . A system for trigeminal nerve stimulation comprising:
 a pulse generator; and   a cutaneous electrode assembly in electrical communication with the pulse generator, the cutaneous electrode assembly comprising:
 a first electrode comprising at least one contact configured for cutaneous placement at a first region of a face of a patient, wherein the first electrode is configured to contact a portion of the face of the patient overlying a cutaneous distribution of the maxillary nerve or the mandibular nerve; and 
 a second electrode comprising at least one contact configured for cutaneous placement at a second region of the face of the patient, wherein the second electrode is configured to contact a portion of the face of the patient overlying the cutaneous distribution of the maxillary nerve or the mandibular nerve. 
   
     
     
         10 . The system of  claim 9 , further comprising a wire operably connecting the pulse generator and the cutaneous electrode assembly. 
     
     
         11 . The system of  claim 9 , further comprising a regulating device configured to regulate a maximum charge balanced output current below about 30-50 mA. 
     
     
         12 . The system of  claim 9 , wherein the pulse generator is configured to apply electrical signals at a frequency between about 20 and 300 Hertz, at a pulse duration between about 50 and 500 microseconds, at an output current density of not greater than about 25 mA/cm 2 , and output charge density of not greater than about 10 microCoulomb/cm 2  at the cerebral cortex. 
     
     
         13 . A kit for trigeminal nerve stimulation comprising:
 the system of  claim 9 ; and   instructions for placing the cutaneous electrode assembly on the patient for treatment of a neurological disorder or condition.   
     
     
         14 . The kit of  claim 13 , further comprising instructions for applying electrical signals to the cutaneous electrode assembly for treatment of the neurological disorder or condition. 
     
     
         15 . A kit for trigeminal nerve stimulation comprising:
 the system of  claim 9 ; and   instructions for placing the cutaneous electrode assembly on the patient for treatment of a neuropsychiatric disorder.   
     
     
         16 . The kit of  claim 15 , further comprising instructions for applying electrical signals to the cutaneous electrode assembly for treatment of the neuropsychiatric disorder. 
     
     
         17 . A method for treating a neurological disorder or condition comprising:
 contacting a first region of a face of a patient with a cutaneous electrode assembly, the cutaneous electrode assembly comprising:
 a first electrode comprising at least one contact configured for cutaneous placement at the first region of the face of the patient, wherein the first electrode is configured to contact a portion of the face of the patient overlying a cutaneous distribution of the maxillary nerve or the mandibular nerve; 
 a second electrode comprising at least one contact configured for cutaneous placement at a second region of the face of the patient, wherein the second electrode is configured to contact a portion of the face of the patient overlying the cutaneous distribution of the maxillary nerve or the mandibular nerve; and 
   applying electrical signals to the cutaneous electrode assembly at specified operational parameters to treat the neurological disorder or condition.   
     
     
         18 . The method of  claim 17 , wherein applying electrical signals comprises applying electrical signals at a frequency between about 20 and 300 Hertz, at a current of 0.05 to 5 mA, and at a pulse duration of less than or equal to 500 microseconds. 
     
     
         19 . The method of  claim 17 , wherein applying electrical signals comprises applying electrical signals at a frequency between about 20 and 300 Hertz, at a pulse duration between about 50 and 500 microseconds, at an output current density of not greater than about 25 mA/cm 2 , and output charge density of not greater than about 10 microCoulomb/cm 2  at the cerebral cortex. 
     
     
         20 . The method of  claim 17 , wherein the neurological disorder or condition is selected from epilepsy, seizure-related disorders, acute brain injury, chronic brain injury, chronic daily headache, migraine, disorders related to migraine and headache, and movement disorders. 
     
     
         21 . A method for treating a neuropsychiatric disorder comprising:
 contacting a first region of a face of a patient with a cutaneous electrode assembly, the cutaneous electrode assembly comprising:
 a first electrode comprising at least one contact configured for cutaneous placement at the first region of the face of the patient, wherein the first electrode is configured to contact a portion of the face of the patient overlying a cutaneous distribution of the maxillary nerve or the mandibular nerve; 
 a second electrode comprising at least one contact configured for cutaneous placement at a second region of the face of the patient, wherein the second electrode is configured to contact a portion of the face of the patient overlying the cutaneous distribution of the maxillary nerve or the mandibular nerve; and 
   applying electrical signals to the cutaneous electrode assembly at specified operational parameters to treat the neuropsychiatric disorder.   
     
     
         22 . The method of  claim 21 , wherein applying electrical signals comprises applying electrical signals at a frequency between about 20 and 300 Hertz, at a current of 0.05 to 5 mA, and at a pulse duration of less than or equal to 500 microseconds. 
     
     
         23 . The method of  claim 21 , wherein applying electrical signals comprises applying electrical signals at a frequency between about 20 and 300 Hertz, at a pulse duration between about 50 and 500 microseconds, at an output current density of not greater than about 25 mA/cm 2 , and output charge density of not greater than about 10 microCoulomb/cm 2  at the cerebral cortex. 
     
     
         24 . The method of  claim 21 , wherein the neuropsychiatric disorder is selected from mood disorder, cognitive disorder, behavioral disorder, or anxiety disorder.