# US 11,077,315 B2 · Method and system for modulating the brain electrical activity > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,077,315 B2 - Document ID: US11077315B2 - Status: Granted - Kind: B2 - Application number: 16/333,172 - Filed: 2017-09-14 - Published: 2019-07-18 - Granted: 2021-08-03 - Earliest claimed: 2016-09-14 - Assignees: Policlinico San Donato S.P.A. - Istituto Di Ricovero E Cura A Carattere Scientifico - Applicants: Policlinico San Donato S.P.A.-Istituto Di Ricovero E Cura A Carattere Scientifico - Inventors: Livio Luzi - Web page: https://patentgrep.com/patent/US11077315B2 ## CPC - A61N 2/006: {for magnetic stimulation of nerve tissue} - A61N 2/02: using magnetic fields produced by coils, including single turn loops or electromagnets (A61N2/12 takes precedence) - A61N 1/36025: {for treating a mental or cerebral condition} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract A deep and repetitive transcranial magnetic stimulation of an individual is performed by applying magnetic pulses at least to a region of the scalp of the individual, the region being at least the bilateral prefrontal cortex, and can include preferably the bilateral prefrontal cortex and can include the insula. A threshold intensity of the magnetic pulses is determined by applying to the individual one or more reference magnetic stimulations, and a reaction of the individual to the reference stimulation is determined. The reaction corresponds to a right thumb movement. A magnetic stimulation is repeatedly applied for at least 80 trains per session for a duration not exceeding 2 seconds each with a time interval between a train application and the next one not less than 20 seconds, wherein the magnetic stimulation has a frequency of at least 18 Hz with an intensity of stimulation at least 120% of the threshold intensity. ## Claims ### Claim 1 A method for a deep and repetitive transcranial magnetic stimulation of an individual by means of magnetic pulses applied to a region of a scalp of the individual, said region being at least the a bilateral prefrontal cortex, the method comprising the following steps: determining a threshold intensity of said magnetic pulses by applying to the individual one or more reference magnetic stimulations and determining a reaction of the individual to said one or more reference magnetic stimulations, wherein said reaction corresponds to a right thumb movement; and repeatedly applying a magnetic stimulation for at least 80 application trains per session of a duration not exceeding 2 seconds each with one time interval between an application train and the next one no less than 20 seconds, wherein said magnetic stimulation has a frequency of at least 18 Hz with an intensity of stimulation of at least 120% of threshold intensity, wherein the step of determining a threshold intensity comprises: applying the one or more reference magnetic stimulations to a scalp region of the individual corresponding to a primary motor cortex, and decreasing an intensity of the one or more reference magnetic stimulations at regular intervals until obtaining the threshold intensity corresponding to a lowest stimulation intensity needed to determine said reaction of the individual. ### Claim 2 (depends on 1) The method according to claim 1, further comprising a step of measuring the temperature of the individual through an infrared thermography unit in an interscapular region of said individual to determine a dopaminergic activation. ### Claim 3 (depends on 2) The method according to claim 2, wherein the temperature of the individual in the interscapular region increases selectively by at least 1° C. after a repeated application of magnetic stimulation for a treatment less than 30 minutes. ### Claim 4 (depends on 1) The method of claim 1, wherein said region includes an insula. ### Claim 5 A method for modulating a composition of a microbiota of an individual comprising the following steps: determining a threshold intensity of magnetic pulses by applying to the individual one or more reference magnetic stimulations and determining a reaction of the individual to said one or more reference magnetic stimulations, wherein said reaction corresponds to a right thumb movement; and repeatedly applying a magnetic stimulation for at least 80 application trains per session of a duration not exceeding 2 seconds each with one time interval between an application train and the next one no less than 20 seconds, wherein said magnetic stimulation has a frequency of at least 18 Hz with an intensity of stimulation of at least 120% of threshold intensity, wherein the step of determining a threshold intensity comprises: applying the one or more reference magnetic stimulations to a scalp region of the individual corresponding to a primary motor cortex, and decreasing an intensity of the one or more reference magnetic stimulations at regular intervals until obtaining the threshold intensity corresponding to a lowest stimulation intensity needed to determine said reaction of the individual. ### Claim 6 (depends on 5) The method according to claim 5, wherein the microbiota is enriched with bacteria having anti-inflammatory and/or adjuvant properties of intestinal metabolism. ### Claim 7 (depends on 6) The method according to claim 6 wherein said bacteria belong to the Faecalibacterium and/or Alistipes genera. ### Claim 8 A system for the deep and repetitive transcranial magnetic stimulation of an individual by means of magnetic pulses applied at least to a scalp region of the individual, said region being at least the a bilateral prefrontal cortex, the system comprising: stimulation means for generating and applying a magnetic stimulation, said means comprising a pulse generator of magnetic pulses and stimulating elements; and computer hardware and software for managing and controlling the magnetic stimulation, wherein said computer hardware and software are configured to: determine a threshold intensity of the magnetic pulses by applying to the individual one or more reference magnetic stimulations, determine a reaction of the individual to said one or more reference magnetic stimulations, wherein said reaction corresponds to a movement of the right thumb, and manage the stimulation means so as to perform, after the determination of the threshold intensity, the magnetic stimulation comprising at least 80 application trains per session of a duration not exceeding 2 seconds each with a time interval between an application train and the next one not less than 20 seconds, said magnetic stimulation having a pulse frequency of at least 18 Hz and a stimulation intensity of at least 120% of the threshold intensity, wherein the step of determining a threshold intensity comprises: applying the one or more reference magnetic stimulations to a scalp region of the individual corresponding to a primary motor cortex, and decreasing an intensity of the one or more reference magnetic stimulation at regular intervals until obtaining the threshold intensity corresponding to a lowest stimulation intensity needed to determine said reaction of the individual. ### Claim 9 (depends on 8) The system according to claim 8, wherein the stimulation means comprise an “H”-shaped coil for deep transcranial magnetic stimulation. ### Claim 10 (depends on 8) The system according to claim 8, further comprising an infrared thermography unit for detecting a selective temperature increase of the skin of the individual and means for measuring movement of the individual, wherein said means for measuring movement of the individual is an accelerometer. ### Claim 11 A method for regulating glucose metabolism and/or reducing blood glucose levels of an individual by deep and repetitive transcranial magnetic stimulation by means of magnetic pulses applied at least to a region of a scalp of the individual, said region being at least a bilateral prefrontal cortex, wherein the method initially comprises determining a threshold intensity of the magnetic pulses by applying to the individual one or more reference magnetic stimulations and determining a reaction of the individual to said one or more reference stimulations, wherein said reaction corresponds to a movement of a right thumb and subsequently a repeated application of a magnetic stimulation at a pulse frequency greater than or equal to 1 Hz with an intensity greater than said threshold intensity, wherein said method is not aimed at reducing an individual's dependence on a particular substance or habit, and wherein the threshold intensity determination occurs by applying the one or more reference magnetic stimulations to a scalp area corresponding to a primary motor cortex at regular intervals gradually decreasing an intensity of said one or more reference stimulations until obtaining the threshold intensity corresponding to a lowest stimulation required to determine said reaction of the individual. ### Claim 12 (depends on 11) The method according to claim 11, wherein the repeated application of the magnetic stimulation modulates a regulation of the an activity of a sympathetic nervous system and/or causes a change in a level of hormones selected from the group consisting of insulin, leptin, adrenaline and ghrelin in the individual. ### Claim 13 (depends on 11) The method according to claim 11, wherein the repeated application of the magnetic stimulation occurs at a frequency of at least 18 Hz with a stimulation intensity of at least 120% of the threshold intensity. ### Claim 14 (depends on 13) The method according to claim 13, wherein the repeated application of magnetic stimulation comprises at least 80 application trains per session, each having a duration of no more than 2 seconds with a time interval between a train application and the next one no less than 20 seconds. ### Claim 15 (depends on 11) The method according to claim 11, wherein the magnetic stimulation is applied to an area of the scalp of the individual to indirectly influence a cerebral area corresponding to an arcuate nucleus by induction of electric current in said cerebral area as a consequence of the stimulation of a prefrontal cortex and insula. ### Claim 16 (depends on 11) The method of claim 11, wherein said region includes an insula.