# US 10,946,196 B2 · System for variably configurable, adaptable electrode arrays and effectuating software > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,946,196 B2 - Document ID: US10946196B2 - Status: Granted - Kind: B2 - Application number: 15/290,391 - Filed: 2016-10-11 - Published: 2017-03-30 - Granted: 2021-03-16 - Earliest claimed: 2012-11-16 - Assignees: StimScience Inc. - Applicants: StimScience Inc. - Inventors: Michael P. Weisend - Web page: https://patentgrep.com/patent/US10946196B2 ## CPC - A61N 1/36025: {for treating a mental or cerebral condition} - A61B 5/0075: {by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy (A61B5/0071 takes precedence)} - A61B 5/245: specially adapted for magnetoencephalographic [MEG] signals - A61B 5/291: for electroencephalography [EEG] - A61B 5/369: Electroencephalography [EEG] - A61B 5/4064: {Evaluating the brain (for intracranial pressure A61B5/031; for cerebral blood gases A61B5/14553; using EEG A61B5/369)} - A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)} - A61B 6/037: {Emission tomography} - A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]} - A61N 1/0476: {Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)} - A61B 5/4094: {Diagnosing or monitoring seizure diseases, e.g. epilepsy} - A61B 5/4812: {Detecting sleep stages or cycles} - A61N 1/0526: {Head electrodes (A61N1/0551 takes precedence)} - A61N 1/3603: {Control systems} - A61N 2/006: {for magnetic stimulation of nerve tissue} - A61N 2007/0026: {Stimulation of nerve tissue} - 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) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Electrical non-invasive brain stimulation (NIBS) delivers weak electrical currents to the brain via electrodes that are affixed to the scalp. NIBS can excite or inhibit the brain in areas that are impacted by that electrical current during and for a short time following stimulation. Electrical NIBS can be used to change brain structure in terms of increasing white matter integrity as measured by diffusion tensor imaging. Together the electrical NIBS can induce changes in brain structure and function. The present methods and devices are adaptable to and configurable for facilitating the enhancement of brain performance, and the treatment of neurological diseases and tissues. The present methods and devices are advantageously designed to utilize modern electrodes deployed with, inter alia, various spatial arrangements, polarities, and current strengths to target brain areas or networks to thereby enhance performance or deliver therapeutic interventions. ## Claims ### Claim 1 An electrode assembly, comprising: at least one electrode, wherein each electrode comprises an opening therethrough; a housing for positioning the at least one electrode relative to a tissue region, wherein a non-conductive material coupled to the at least one electrode extends from a bottom surface of the housing and defines a cavity such that the opening defined through the at least one electrode is open to the cavity, and wherein the housing is a reconfigurable housing comprising a plurality of components each having a shape that is a sector of a circular shape, the plurality of components collectively forming the circular shape, and the plurality of components being configured to removably couple the at least one electrode to other electrodes to form one of a plurality of arrangements; and a controller in electrical communication with the at least one electrode, wherein the controller is programmed to apply a stimulation through the at least one electrode over a ramp up period, a treatment period, and a ramp down period, and wherein the controller is further programmed to apply the stimulation to one or more locations of a patient scalp surface identified as regions of maximal current density corresponding to a pattern of electrical activity modeled from a difference image, wherein a placement of the at least one electrode is determined based, at least in part, on the difference image. ### Claim 2 (depends on 1) The assembly of claim 1 wherein each of the at least one electrode has a circular configuration. ### Claim 3 (depends on 1) The assembly of claim 1 further comprising a power supply adapted and arranged for providing electrical power to the at least one electrode. ### Claim 4 (depends on 1) The assembly of claim 1 wherein the controller is in operative communication with a computer system external to the controller. ### Claim 5 (depends on 1) The assembly of claim 1 further comprising a head frame adapted and arranged for holding the at least one electrode and the housing in one or more positions with respect to a scalp upon which the electrodes or housing are positioned. ### Claim 6 (depends on 1) The assembly of claim 1 wherein the ramp up period ranges from 10 seconds to 15 minutes. ### Claim 7 (depends on 1) The assembly of claim 1 wherein the ramp up period is variable. ### Claim 8 (depends on 1) The assembly of claim 1 wherein the ramp down period is variable. ### Claim 9 (depends on 1) The assembly of claim 1 wherein the treatment period ranges from 0.1 minutes to 60 minutes. ### Claim 10 (depends on 1) The assembly of claim 1 wherein the treatment period comprises applying time-varying stimulation having a frequency of 0 to 10,000 Hz. ### Claim 11 (depends on 1) The assembly of claim 1 wherein the treatment period has a current which ranges from 0.1 mA to 4 mA. ### Claim 12 (depends on 1) The assembly of claim 1 wherein the ramp down period ranges from 10 secs to 15 mins. ### Claim 13 (depends on 1) The assembly of claim 1 wherein the at least one electrode is included in an electrode assembly having two or more electrodes for positioning relative to corresponding one or more locations of the patient scalp surface. ### Claim 14 (depends on 13) The assembly of claim 13 further comprising a head frame configured to individually position the two or more electrodes relative to the one or more locations of the patient scalp surface. ### Claim 15 (depends on 1) The assembly of claim 1 wherein the controller is configured to drive a plurality of current sources independent from one another. ### Claim 16 (depends on 15) The assembly of claim 15 wherein the controller is configured to control a voltage level of each current source according to a waveform input for each current source. ### Claim 17 (depends on 15) The assembly of claim 15 wherein the controller is configured to monitor for an open circuit. ### Claim 18 (depends on 15) The assembly of claim 15 wherein the controller is configured to monitor an impedance associated with each of the plurality of current sources and determine a mean impedance value. ### Claim 19 (depends on 18) The assembly of claim 18 wherein the controller is configured to adjust each current source over an electrode-to-scalp connection impedance range of 4 to 40,000 Ohms. ### Claim 20 (depends on 15) The assembly of claim 15 wherein the controller is configured to perform internal calculations to determine a waveform to be delivered to the patient scalp surface via the at least one electrode. ### Claim 21 (depends on 15) The assembly of claim 15 wherein an impedance is measured independently for each current source. ### Claim 22 (depends on 15) The assembly of claim 15 wherein a maximum voltage for each current source is determined at a beginning of the stimulation based on a measured impedance associated with each current source so as to inhibit a relatively high current from being delivered. ### Claim 23 (depends on 15) The assembly of claim 15 wherein the controller is configured to receive multiple trigger inputs. ### Claim 24 (depends on 15) The assembly of claim 15 wherein the controller is configured with a network interface. ### Claim 25 (depends on 24) The assembly of claim 24 wherein the network interface is configured to remotely receive servicing or activation signals in response to brain or behavioral states. ### Claim 26 (depends on 15) The assembly of claim 15 wherein the controller comprises storage configured to retain treatment data. ### Claim 27 (depends on 26) The assembly of claim 26 wherein the treatment data comprises at least one waveform that determines frequency, amplitude, latency, location, and duration of the stimulation. ### Claim 28 The assembly of 15 wherein the controller is configured to communicate with one or more additional controllers. ### Claim 29 The assembly of 15 wherein the controller is configured to operate the plurality of current sources with independent or common references so that transcranial direct current stimulation (TDCS), transcranial alternating current stimulation (TACS), transcranial random noise stimulation (TRNS), and time varying electrical stimulation (TVES) are presentable in any combination. ### Claim 30 The assembly of 15 wherein the controller is configured to allow current steering across the plurality of current sources such that a total current sums to zero. ### Claim 31 (depends on 1) The assembly of claim 1 wherein the controller is configured to transmit data relating to the stimulation to a device located remotely from the controller. ### Claim 32 (depends on 1) The assembly of claim 1 wherein the controller is configured to lock out any further stimulation for a predetermined period of time once a treatment session has been completed.