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

Description

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