HIGHLAND INSTRUMENTS INC — Department of Health and Human Services SBIR Phase I: 103

Description

ProprietaryThis proposal includes trade secrets and other proprietary or confidential information of Highland Instruments and is being provided for use by the National Institutes of HealthNIHfor the sole purpose of evaluating this SBIR proposalNo other rights are conferredThis proposal and the trade secrets and other proprietary or confidential information contained herein shall further not be disclosed in whole or in partsoutside of NIH without Highland Instrumentandapos s permissionThis restriction does not limit the NIHandapos s right to use information contained in the data if it is obtained fromanother source without restrictionThis legend applies to the entire proposalincludingbut not limited to the AbstractIntroductionSpecific AimsResearch Planall componentsCommercialization Planand Human Subjectandapos s Sections of this proposalAbstract In patients with Parkinson s DiseasePDpostural instability is a leading cause of disabilitydependence on othersand mortalityCurrent treatments for PDincluding pharmacological and surgical methodshave limited impact on postural instabilityPhysical therapyPTfor PD is becoming increasingly used as a means to induce exercise dependent plasticity that can result in significant benefits for patient balanceHoweverPT is still untailored to each patient needand has not been optimized to work synergistically with other therapies in PDIn recent yearsthere has been an increased interest in the use of noninvasive brain stimulationNIBSdevices for the treatment of PD and in their ability to couple their effects with PT regimensButultimately conventional NIBS methods have showed minimal and inconsistent effects on PD symptomsand in particular patient balanceIt has been postulated that these techniqueslimitations in focalitypenetrationand targeting control translate into their limited therapeutic effectsElectrosonic StimulationESStimis 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 tissueThis proposal is focused on evaluating the therapeutic impact of ESStim in PD patients as adjunct therapy to PTFirst in Phase Iwe will followPD patientsSHAM ESStimactive ESStimundergoing PT after giving a fixed dose of ESStim fordays of stimulationmins dayover a twoweek periodWe will assess a battery of electrophysiologycognitiveand neurological safety markersbalanceQuality of LifeQOLteststhe Unified Parkinson s Disease Rating ScaleUPDRSand sensorbasedbiomechanical metrics during bradykinesiapostureand walking abilities gait tests over theweek period and for at least six weeks following the last treatment sessionNext in Phase IIwe will followPD patientsSHAMactive ESStim stimulationafter providing treatment over a monthi eincreasing treatment byweeksand assess the patients as abovebut now for at leastweeks after treatment endsFinallywe will test whether the effects of ESStim enhanced PT training for postural instability in PD can be guided by the baseline disease state and the effective dose of stimulationTo test this we will build and evaluate multivariate linear and generalized linear regression models to predict the clinical outcomesWe will also build MRI derived models of the stimulation fields in the brainelectrical and sonic field modelsof each of the PD subjects and correlate the stimulatory field characteristics with therapeutic outcomesOverallwe hypothesize that the proposed experimentscomputational studiesand technology development will allow us to test the effectiveness of ESStim as adjunct therapy to PT in PD patientsThe results of the proposed work will serve as the basis for a future large scale multicenter study to further validate the technique and optimize the methodology of ESStim coupled with PT for use in PD therapy Project Narrative In patients with Parkinsonandapos s DiseasePDpostural instability is a leading cause of disabilitydependence on othersand mortalityCurrent treatments for PDincluding pharmacological and surgical methodsare not specifically designed to improve balanceand as such their effects on this symptom are limitedThis study analyzes the impact of noninvasive brain stimulation treatments coupled with physical therapy for improving postural instability in PD patients