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Patent
Highland Instruments, Inc. | Date: 2016-01-13

An apparatus for generating focused currents in biological tissue is provided. The apparatus comprises an electric source capable of generating an electric field across a region of tissue and means for altering the permittivity of the tissue relative to the electric field, whereby a displacement current is generated. The means for altering the permittivity may be a chemical source, optical source, mechanical source, thermal source, or electromagnetic source.


Patent
Highland Instruments, Inc. | Date: 2015-08-07

An apparatus for generating focused currents in biological tissue is provided. The apparatus comprises an electric source capable of generating an electric field across a region of tissue and means for altering the permittivity of the tissue relative to the electric field, whereby a displacement current is generated. The means for altering the permittivity may be a chemical source, optical source, mechanical source, thermal source, or electromagnetic source.


Patent
Highland Instruments, Inc. | Date: 2015-02-02

An apparatus for generating focused currents in biological tissue is provided. The apparatus comprises an electric source capable of generating an electric field across a region of tissue and means for altering the permittivity of the tissue relative to the electric field, whereby a displacement current is generated. The means for altering the permittivity may be a chemical source, optical source, mechanical source, thermal source, or electromagnetic source.


Patent
Highland Instruments, Inc. | Date: 2014-07-18

The invention generally relates to methods for guiding physical therapy to a subject. In certain embodiments, methods of the invention involve providing stimulation to a subjects central nervous system to modulate one or more signals sent to or from a plurality of target regions of the subject. Methods of the invention further involve assessing the response of the plurality of target regions to the stimulation to determine if there is a differential response among the target regions to the stimulation, and providing focused physical therapy to at least one of the target regions based on the assessment of the response of the plurality of peripheral target regions to the stimulation.


Patent
Highland Instruments, Inc. | Date: 2015-07-16

The invention generally relates to methods for improving balance of a subject. In certain embodiments, methods of the invention involve noninvasively providing stimulation to a central nervous system of an awake subject to modulate a signal sent to or from the awake subjects central nervous system, such that the stimulation to the central nervous system improves balance of the subject.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 224.40K | Year: 2016

Proprietary This proposal includes trade secrets and other proprietary or confidential information of Highland Instruments and is being provided for use by the National Institutes of Health NIH for the sole purpose of evaluating this SBIR proposal No other rights are conferred This proposal and the trade secrets and other proprietary or confidential information contained herein shall further not be disclosed in whole or in parts outside of NIH without Highland Instrumentandapos s permission This restriction does not limit the NIHandapos s right to use information contained in the data if it is obtained from another source without restriction This legend applies to the entire proposal including but not limited to the Abstract Introduction Specific Aims Research Plan all components Commercialization Plan and Human Subjectandapos s Sections of this proposal Abstract Chronic low back pain CLBP is a leading cause of pain and disability Non specific low back pain i e without a known cause is the most pervasive type of back pain Current therapies do not directly address the fact that pain sensation is processed in the brain even though non specific chronic low back pain NSCLBP symptomology can correlate with chronic pain induced changes in brain activity and or structure Non Invasive Brain Stimulation NIBS has been successfully applied for the treatment of chronic pain in some disease states where treatment induced changes in brain activity revert maladaptive plasticity associated with the perception sensation of chronic pain However the most common NIBS methods Transcranial Magnetic Stimulation TMS and Transcranial Direct Current Stimulation tDCS have shown limited if any efficacy in treating NSCLBP It has been postulated that limitations in these techniquesandapos focality penetration and targeting control limit their therapeutic efficacy Electrosonic Stimulation ESStim is an improved NIBS modality that overcomes the limitations of other technologies by combining independently controlled electromagnetic and ultrasonic fields to focus and boost stimulation currents via tuned electromechanical coupling in neural tissue This proposal is focused on evaluating whether our noninvasive ESStim system can effectively treat NSCLBP First in Phase I to assess the feasibility of the proposed work we will follow NSCLBP patients after giving a fixed dose of ESStim for days min day over a two week period SHAM ESStim ESStim We will assess a battery of safety pain quantitative sensory testing QST function and global psychosocial self assessments in the patients evaluated over the treatment period and for at least six weeks following the last treatment session Next in Phase II we will follow NSCLBP patients ESStim SHAM after giving a fixed dose of stimulation for days min day over a two week period followed by three weeks of bi weekly stimulation min day total stimulations We will evaluate these patients with the same battery of assessments validated in Phase I and compare the efficacy of the tested interventions for at least eight weeks following the last treatment session In parallel with the NSCLBP treatments we will build MRI derived models of the stimulation fields in the heads electric and acoustic field models of the NSCLBP patients to calculate the stimulation field characteristics at the brain target sites Multivariate linear and generalized linear regression models will then be built and evaluated to predict the NSCLBP patient outcomes related to pain physical function and psychosocial assessments as a function of baseline disease characteristics and the MRI based dosing models The computational work will be combined to develop an optimized NSCLBP ESStim dosing model Overall we hypothesize that the proposed experiments computational studies and technology development will allow us to optimize ESStim for NSCLBP treatment Project Narrative Chronic low back pain is a leading cause of disability in the United States This study explores the optimization of electrosonic stimulation ESStim a novel form of noninvasive brain stimulation for treating the symptoms of nonspecific chronic low back pain


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 2.69M | Year: 2013

DESCRIPTION provided by applicant The past decade has seen a rapid increase in the application of brain stimulation devices to treat a variety of movement disorders such as Parkinsonandapos s disease PD and other neuropathologies Present noninvasive brain stimulation technologies suffer from fundamental limitations and have yet to reach the level of efficacy of invasive methods such as deep brain stimulation DBS Electrosonic Stimulation ESStim is an improved noninvasive modality which offers the potential of more focal and deeper effects Preliminary studies with this technique have confirmed improved focality and penetration compared to other forms of noninvasive stimulation e g transcranial DC stimulation tDCS which have translated into a greater magnitude and duration of stimulatory effect compared to the other technologies This application is focused on evaluating the therapeutic impact of ESStim in PD patients First in Phase I we will follow PD patients SHAM active ESStim stimulation after giving a constant fixed dose of ESStim for days of stimulation mins day over a two week period We will assess a battery of electrophysiology cognitive and neurological safety markers in the patients including channel EEG California Computerized Assessment Package verbal fluency test n back working memory test PD Adverse Effects Questionnaire and neurological exams Additionally we will evaluate the Unified Parkinsonandapos s Disease Rating Scale UPDRS bradykinesia test and walking abilities gait in the PD patients evaluated over the week period and for at least six weeks following the last stimulation session Next in Phase II we will follow PD patients SHAM active ESStim stimulation tDCS and TUS after giving a constant fixed dose of stimulation for days mins day over a two week period We will evaluate these patients with a battery of Motor Safety Mechanistic and Quality of Life QOL tests comparing the efficacy of the tested interventions In parallel with the PD treatments field models of the electromagnetic and sonic fields generated in the brain will be developed with MRI based computational models of each patient and correlated with the efficacy measures recorded during and after the treatment sessions to develop dosing models based on the individualized patient data Overall we hypothesize that the proposed experiments computational studies and technology development will allow us to test the effectiveness of ESStim compared to other noninvasive technologies in PD patients The results of the proposed work will serve as the basis for a future large scale multicenter study to further validate the technique and optimize equipment for use in PD therapy Future developments with this technology and stimulation method could provide a platform for innovative and improved neurological treatments Parkinsonandapos s Disease PD is a debilitating motor disorder with limited treatment options and as the disease progresses it can require invasive surgical procedures to implant brain stimulation devices in patientsandapos brains to treat the disease Electrosonic Stimulation ESStimandquot is a noninvasive neurostimulation method which improves upon current noninvasive technologies with superior focality targeting control and penetration and for the first time offers the possibility of noninvasive deep brain stimulation i e stimulatig deep brain structures without maximally stimulating the surface This study analyzes stimulation treatments in PD patients while exploring technology that can impact other neuropathologies that are currently underserved by present noninvasive options


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 974.18K | Year: 2015

DESCRIPTION provided by applicant This proposal includes trade secrets and other proprietary or confidential information of Highland Instruments and is being provided for use by the National Institutes of Health NIH for the sole purpose of evaluating this SBIR proposal No other rights are conferred This proposal and the trade secrets and other proprietary or confidential information contained herein shall further not be disclosed in whole or in parts outside of NIH without Highland Instrumentandapos s permission This restriction does not limit the NIHandapos s right to use information contained in the data if it is obtained from another source without restriction This legend applies to the entire proposal including but not limited to the Abstract Introduction Specific Aims Research Plan all components Commercialization Plan and Human Subjectandapos s Sections of this proposal Abstract OA of the knee is a leading cause of chronic pain and disability Conventional treatments do not directly address the fact that pain sensation is processed in the brain and mechanical joint dysfunction can be worsened by chronic pain induced changes in the brainandapos s motor control centers Non Invasive Brain Stimulation NIBS has been successfully applied for the treatment of chronic pain in some disease states where treatment induced changes in brain activity revert maladaptive plasticity associated with the perception sensation of chronic pain However the most common NIBS methods Transcranial Magnetic Stimulation TMS and Transcranial Direct Current Stimulation tDCS fail to show consistent clinical benefit on par with that of the conventional pain treatments and are not commonly used for OA therapy It has been postulated that limitations in these techniquesandapos focality penetration and targeting control limit their therapeutc efficacy Electrosonic Stimulation ESStim tm is an improved NIBS modality that overcomes the limitations of other technologies by combining independently controlled electromagnetic and ultrasonic fields to focus and boost stimulation currents via tuned electromechanical coupling in neural tissue This proposal is focused on evaluating whether our noninvasive ESStim system can effectively treat chronic OA pain and in turn improve knee biomechanical function and patient quality of life QOL First in Phase I to assess the feasibilit of the proposed work we will follow OA patients after giving a constant fixed dose of ESStim for min day on consecutive days SHAM ESStim ESStim We will assess a battery of safety pain biomechanical knee function and QOL measures in the patients evaluated over the treatment period and for at least six weeks following the last treatment session Next in Phase II we will follow OA patients after giving a constant fixed dose of stimulation for days min day over a two week period Patients will randomly be assigned to of stimulation conditions ESStim tDCS transcranial ultrasound TUS or SHAM ESStim We will evaluate these patients with the battery of pain biomechanical QOL and safety measures which were validated in the Phase I studies and compare the efficacy of the tested interventions for at least eight weeks following the last treatment session Furthermore we will test whether the ESStim pain suppression can be guided by the baseline disease state To test this we will build and evaluate multivariate linear and generalized linear regression models to predict the clinical outcomes and identify best responders Overall we hypothesize that the proposed experiments computational studies and technology development will allow us to test the effectiveness of ESStim in OA patients The work will serve as the basis for a future large scale multicenter study and further the commercialization of ESStim OA therapy PUBLIC HEALTH RELEVANCE Osteoarthritis OA of the knee is a major cause of chronic pain and a leading cause of disability Alternative therapies such as Non Invasive Brain Stimulation NIBS have been successfully applied for the treatment of chronic pain in other diseases whereby treatment induced changes in brain activity revert maladaptive plasticity associated with the perception sensation of chronic pain This study analyzes NIBS treatments for chronic pain in OA patients


Patent
Highland Instruments, Inc. | Date: 2015-05-05

The invention generally relates to systems and methods for stimulating cellular function in biological tissue. In certain embodiments, the invention provides a method for stimulating cellular function within tissue that involves providing a first type of energy to a region of tissue, in which the first type is provided in an amount that inhibits cellular function within the region of tissue, and providing a second type of energy to the region of tissue, in which the second type is provided in an amount that facilitates cellular function within the region of tissue, wherein the combined effect stimulates cellular function within the tissue.


Patent
Highland Instruments, Inc. | Date: 2015-02-03

An apparatus for interfacing between tissues being stimulated is provided. The apparatus includes an electric source capable of generating an applied electric field across a region of tissue and/or a means for altering at least one electromagnetic characteristic of the region of tissue relative to the applied electric field and an interface component, such interface component creating an interface between the region of tissue and the applied electric field or the means for altering at least one electromagnetic characteristic of the region of tissue.

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