System for variably configurable, adaptable electrode arrays and effectuating software
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Publication Number
US-10946196-B2
Publication Date
2021-03-16
Expiration Date
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.
Core Innovation
The invention provides an electrode assembly for applying stimulation through at least one electrode positioned relative to a tissue region. Each electrode includes an opening therethrough, and a housing extends from a bottom surface to define a cavity with the opening open to the cavity. The housing is a reconfigurable housing comprising a plurality of components each having a shape that is a sector of a circular shape, where the components collectively form the circular shape and are configured to removably couple electrodes to form one of a plurality of arrangements.
A controller in electrical communication with the at least one electrode is programmed to apply stimulation through the at least one electrode over a ramp up period, a treatment period, and a ramp down period. The controller is further programmed to apply 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, with electrode placement determined based, at least in part, on the difference image.
The neuroimaging-guided targeting workflow uses difference images between undesirable and desirable brain states or across time, and finite element modeling (FEM) to virtualize current paths so electrode placement can be moved to maximize current density in target brain regions. The system supports configurable and portable electrode arrays and housings, including circular arrangements formed by sector-shaped components, and controller-driven stimulation behavior that includes ramp up, treatment, and ramp down.
Software and networked embodiments store waveforms and perform modeling to implement the placement determination based on the difference image and the corresponding regions of maximal current density. The disclosed platform is described in the context of neuroimaging-guided NIBS/ng-NIBS and targeting for scalp stimulation, including embodiments intended to improve learning performance and lasting residual effects versus sham.
Claims Coverage
The only independent claim explicitly provided is clm-00001. It contains two principal inventive aspects: (1) a reconfigurable sector-shaped electrode housing with electrode openings connected to a cavity, and (2) controller-controlled ramped stimulation targeted to scalp locations determined from a modeled pattern of electrical activity using a difference image (regions of maximal current density).
Reconfigurable sector-shaped electrode housing with cavity-connected openings
An electrode assembly having at least one electrode with an opening therethrough, and a housing for positioning the electrode relative to a tissue region, where a non-conductive material coupled to the electrode extends from a bottom surface of the housing and defines a cavity such that the opening is open to the cavity, the housing being a reconfigurable housing comprising a plurality of components each having a shape that is a sector of a circular shape that collectively form the circular shape and removably couple the electrode(s) to form one of a plurality of arrangements.
Ramped stimulation targeted to regions of maximal current density from difference-image modeling
A controller in electrical communication with the electrode(s), programmed to apply stimulation through the electrode(s) over a ramp up period, a treatment period, and a ramp down period, and further programmed to apply 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, where placement of the electrode(s) is determined based, at least in part, on the difference image.
Across the dependent claims indicated in the provided excerpt, additional limitations refine stimulation parameters, specify controller adjustment based on electrode-to-scalp connection impedance, and add implementation features such as a network interface. The core claim coverage centers on the reconfigurable sector-shaped electrode housing and neuroimaging-difference-image-driven electrode placement to target modeled maximal current density on the scalp.
Stated Advantages
Improved learning performance and lasting residual effects versus sham.
Documented Applications
Neuroimaging-guided non-invasive brain stimulation (NIBS) targeting using difference images and modeled regions of maximal current density on a patient scalp surface.
Task software contexts are described, including language learning and ability testing, and diagnostic/intervention use cases.
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