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

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 andthe trade secrets and other proprietary or confidential information contained herein shal 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 AbstractSpecific AimsResearch Planal componentsCommercialization Planand Human Subjectandapos s Sections of this proposalAbstractThe USA is undergoing a national crisis of opioid addictionWhile opioid therapy is a mainstay approach for the treatment of moderate to severe painin the chronic painCPpopulationmisuse prescribed opiatesdevelop an opioid related disorderandtransition to heroinAddicts exhibit aberrant brain network stateswhich may be modified through appropriate therapies to reduce addictive behaviorRecent studies have demonstrated that noninvasive brain stimulationNIBSmay be effective in treating some forms of addictionHoweverthe most common NIBS methodse gTranscranial Magnetic StimulationTMSand Transcranial Direct Current StimulationtDCShave not been found to be effective in treating opioid use disorderOUDIt has been postulated that limitations in these techniquesfocalitypenetrationand targeting control limit their therapeutic efficacyElectrosonic StimulationESStimis an improved NIBS modality that overcomes these limitations 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 whether our noninvasive ESStim system can effectively reduce OUD in patients prescribed opioids secondary to CPFirst in Phase Ito assess the feasibility of the proposed workwe will followOUD patients after giving a fixed dose of ESStim forconsecutive daysmin dayActiveSHAMWe will administer a battery of clinical safetydrug useelectrophysiologybehavioraland psychosocial assessments in the OUD patientsevaluated over the treatment period and for at least four weeks following the last treatment sessionNext in the Phase IIwe will followOUD patientsActiveSHAMafter giving a fixed dose of stimulation fordaysmin dayWe will evaluate these patients with the same battery of assessments validated in Phase Ibut now assessments will be made at least twelve weeks following the last treatment sessionIn parallel with the OUD treatmentswe will build MRI derived models of the stimulation fields in the patientsheadselectric and acoustic field modelsto calculate the stimulation field characteristics at the brain target sitesMultivariate linear and generalized linear regression models will then be built and evaluated to predict the patient outcomes as a function of baseline disease characteristics and the MRI based dosing modelsThe results from the computational work will be used to develop an optimized OUD ESStim treatment dosing modelOverallwe hypothesize that the proposed experimentscomputational studiesand technology development will allow us to optimize ESStimfor treatment of OUD secondary to CP and will serve as the foundation to improve the treatment of OUD and addiction in the US Project Narrative The USA is suffering a national crisis of opioid addictionThis study explores the optimization of electrosonic stimulationESStima novel form of noninvasive brain stimulationfor treating Opioid Use Disorder