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

Description

Carpal Tunnel SyndromeCTSaffects up toof the US populationwith higher prevalence in the working populationChronic painCPis one of the most common and difficult to treat complications of CTSCurrent therapiesdo not directly address the fact that pain sensation is processed in the brainand most act at the neuropathy sitei ein the peripheryalthough CTS patients also have a central pain component due to their injuryCTS symptomatology correlates with CP induced changes in brain activity and or structureNon Invasive Brain StimulationNIBShas been successfully applied for the treatment of CP in some disease stateswhere treatment induced changes in brain activity revert maladaptive plasticity associated with the perception sensation of CPHoweverthe most common NIBS methodse gtranscranial direct current stimulationhave shown limitedif anyefficacy in treating neuropathic painIt has been postulated that limitations in conventional NIBS techniquesfocalitypenetrationand 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 CP in CTSboth as a lone treatment and in conjunction with physical therapyPTIn Phase Ito assess the feasibility of the proposed workand specifically test ESStim s ability to improve CTS painwe will followCTS patients after giving a fixed dose of ESStim forconsecutive daysmin daySHAM ESStimESStimWe will administer a battery of safetypainquantitative sensory testingQSTmotor functionand global self assessmentse gQOLevaluated over the treatment period and for at least six weeks following the last treatment sessionNext in Phase IIwe will assess whether ESStim induced pain reductions can be coupled with physical therapyPTto improve CTS treatmentWe will followCTS patientsESStimSHAMafter giving a fixed dose of stimulation fordays over two weeksmin daybut now provided in conjunction with PTWe will evaluate these patients with the battery of assessments validated in Phase Iand compare the efficacy of the tested interventions for at least eight weeks following the last treatment sessionWe hypothesize ESStim can be provided synergistically with PTas both can encourage plasticity dependent changes which could maximally improve a CTS patient s pain free mobilityIn parallel with the CTS treatmentswe will build multivariate linear and generalized linear regression models to predict the CTS patient outcomes related to painphysical functionand psychosocial assessments as a function of baseline disease characteristicsThe computational work will be used to develop an optimized CTS ESStim dosing modelOverallwe hypothesize that we will be able to develop ESStimfor CTS treatment Project Narrative Carpal Tunnel SyndromeCTSaffectsof the United States populationwith a higher prevalence in the working populationChronic painCPis one of the most common and difficult to treat complications of CTSThis study explores the optimization of electrosonic stimulationESStima novel form of noninvasive brain stimulationprovided in conjunction with physical therapyto treat CP in CTS patients