External trigeminal nerve stimulation for the acute non-invasive treatment of migraine attacks

Abstract

The current invention concerns a system and a method for the acute non-invasive treatment of a migraine attack. The system comprises at least one skin electrode for placement on the forehead of a patient. The system is configured for providing consecutive biphasic electrical pulses via said at least one skin electrode to the supratrochlear and supraorbital nerves of the ophthalmic branch of the trigeminal nerve during a prolonged time span. Preferably, the time span is at least 10 minutes.

1 . System for the acute non-invasive treatment of a migraine attack of a patient, comprising at least one skin electrode, the at least one skin electrode configured for placement on the forehead of the patient, the system configured for providing consecutive biphasic electrical pulses via said at least one skin electrode for a prolonged time span. 
     
     
         2 . System according to preceding  claim 1 , wherein said biphasic electrical pulses are in essence rectangular biphasic symmetrical pulses with a zero electrical mean. 
     
     
         3 . System according to any one of preceding  claims 1 and 2 , wherein said time span is at least 10 minutes, preferably at least 25 minutes, more preferably at least 45 minutes, such as 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes, or any value above or in between. 
     
     
         4 . System according to any one of preceding  claims 1 to 3 , wherein the system is configured for providing said consecutive biphasic electrical pulses at a frequency of at least 10 Hz and at most 300 Hz, preferably at a frequency of about 100 Hz. 
     
     
         5 . System according to any one of preceding  claims 1 to 3 , wherein the system is configured for providing said consecutive biphasic electrical pulses at a frequency of at least 150 Hz and at most 500 Hz, preferably at a frequency of at least 240 Hz and at most 360 Hz, most preferably at a frequency of about 300 Hz. 
     
     
         6 . System according to any one of preceding  claims 1 to 5 , wherein each of said consecutive biphasic electrical pulses comprises a width of at least 30 µs and at most 1000 µs, preferably a width of about 250 µs. 
     
     
         7 . System according to any one of preceding  claims 1 to 6 , wherein the system is configured for linearly increasing the amplitude of said consecutive biphasic electrical pulses during a first portion of said time span up to a preconfigured upper amplitude which is maintained during a second subsequent portion of said time span. 
     
     
         8 . System according to preceding  claim 7 , wherein the system comprises a patient-pushable button and the system is configured upon pushing of said button during said time span for maintaining the provided biphasic pulse amplitude at or prior to the time of said pushing of said button throughout the reminder of said time span. 
     
     
         9 . System according to any one of preceding  claims 7 and 8 , wherein said preconfigured upper amplitude is at least 1 mA and at most 50 mA, preferably about 16 mA. 
     
     
         10 . System according to any one of preceding  claims 7 to 9 , wherein said first portion of said time span is at least 1 minute and at most 30 minutes, preferably about 14 minutes. 
     
     
         11 . System according to any one of preceding  claims 7 to 10 , wherein said linear amplitude increase during said first portion of said time span comprises a slope of at least 1.6 µA/s and at most 833 µA/s, preferably at least 8 µA/s and at most 83.3 µA/s, such as 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 µA/s, or any value in between. 
     
     
         12 . System according to any one of preceding  claims 1 to 11 , wherein the at least one skin electrode comprises a bipolar self-adhesive electrode. 
     
     
         13 . System according to any one of preceding  claims 1 to 12 , wherein the at least one skin electrode is configured for stimulation of the supratrochlear and supraorbital nerves of the ophthalmic branch of the trigeminal nerve of the patient, and wherein the system is configured for transcutaneous transmission of consecutive biphasic electrical pulses via said at least one skin electrode to the supratrochlear and supraorbital nerves of the ophthalmic branch of the trigeminal nerve of the patient for a prolonged time span. 
     
     
         14 . System according to preceding  claim 13 , wherein said time span is at least 25 minutes. 
     
     
         15 . System according to any one of preceding  claims 1 to 14 , wherein the system comprises a power-providing device configured for placing at least one battery, the power-providing device further comprising two metallic contacts which can be positioned in electrical contact with the at least one skin electrode, the device and the at least one skin electrode configured for stable placement of the device in contact with the at least one skin electrode, thereby rendering the system comprising the device and the at least one skin electrode portable. 
     
     
         16 . Method for the acute non-invasive treatment of a migraine attack of a patient, the patient comprising a forehead, a supratrochlear nerve, and a supraorbital nerve, comprising the steps of:
 a. placing at least one skin electrode on the forehead of said patient, preferably said at least one skin electrode comprising a bipolar self-adhesive electrode;   b. providing consecutive biphasic electrical pulses via said at least one skin electrode to said supratrochlear and said supraorbital nerves for a prolonged time span, 
 preferably said biphasic electrical pulses in essence rectangular biphasic symmetrical pulses with a zero electrical mean, preferably said time span at least 25 minutes, more preferably said time span at least 45 minutes, such as such as 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes, or any value above or in between, preferably said consecutive biphasic electrical pulses provided at a frequency of about 100 Hz or about 300 Hz, preferably each of said consecutive biphasic electrical pulses comprising a width of about 250 µs, preferably said consecutive biphasic electrical pulses comprising an amplitude which increases linearly over a first portion of said time span up to an upper amplitude which is maintained during a second subsequent portion of said time span, preferably said upper amplitude one of a predefined upper amplitude of about 16 mA or a patient-determined upper amplitude of at most 16 mA, preferably the slope of said linear increase about 19 µA/s.