HIGHLAND INSTRUMENTS INC — Department of Health and Human Services SBIR Phase I: 200

Description

AbstractDiabetic neuropathic painDNPis one of the most common and difficult to treat complications of diabetesCurrent therapiesdo not directly address the fact that pain sensation is processed in the brainand most act at the neuropathy sitei ein the peripheryalthough DNP patients also have a central pain component due to their injuryDNP symptomatology correlates with chronic pain induced changes in brain activity and or structureNon Invasive Brain StimulationNIBShas been successfully applied for the treatment of chronic pain in some disease stateswhere treatment induced changes in brain activity revert maladaptive plasticity associated with the perception sensation of chronic painHoweverthe most common NIBS methodsTranscranial Magnetic StimulationTMSand Transcranial Direct Current StimulationtDCShave shown limitedif anyefficacy in treating neuropathic pain and DNPIt has been postulated that limitations in these techniquesandaposfocalitypenetrationand targeting control limit their therapeutic efficacyElectrosonic 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 whether our noninvasive ESStim system can effectively treat DNPFirst in Phase Ito assess the feasibility of the proposed workwe will followDNP patients after giving a fixed dose of ESStim forconsecutive daysmin daySHAM ESStimESStimWe will administer a battery of safetypainquantitative sensory testingQSTmotor functionand global self assessmentse gQOLand actigraphy measures in the patientsevaluated over the treatment period and for at least six weeks following the last treatment sessionNext in Phase IIwe will followDNP patientsESStimSHAMafter giving a fixed dose of stimulation forconsecutive daysmin dayfollowed by three weeks of biweekly stimulationmin daytotal stimulationsWe will evaluate these patients with the same battery of assessments validated in Phase Iand compare the efficacy of the tested interventions for at least eight weeks following the last treatment sessionIn parallel with the DNP treatmentswe will build MRI derived models of the stimulation fields in the headselectric and acoustic field modelsof the DNP patients to 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 DNP patient outcomes related to painphysical functionand psychosocial assessments as a function of baseline disease characteristics and the MRI based dosing modelsThe computational work will be combined to develop an optimized DNP ESStim dosing modelOverallwe hypothesize that the proposed experimentscomputational studiesand technology development will allow us to optimize ESStimfor treatment of central pain in DNP Project Narrative Diabetes is a major cause of morbidity and mortality in the United StatesDiabetic neuropathic pain is one of the most common and difficult to treat complications of diabetesThis study explores the optimization of electrosonic stimulationESStima novel form of noninvasive brain stimulationfor treating the symptoms of diabetic neuropathic pain