ACOUSTIC MEDSYSTEMS, INC. — Department of Health and Human Services SBIR Phase I: 105

Description

ABSTRACT The economic burden of chronic pain in the U Sis staggeringIn the cases of medically refractory chronic neuropathic painneuromodulationsuch as spinal cord stimulationSCSand or dorsal root ganglionDRGstimulationis a non opioid based optionThough neuromodulation is typically electricalhere we examine an alternative with pulsed high intensity focused ultrasoundHIFUDelivering HIFU at lower doses in a pulsed fashion has been shown to temporarily block compound action potentials in pre clinical modelsThough the blockage lasts seconds to minutesour lab has shown that using either invasive or external HIFUthe antinociceptive responses induced by the thermal energy last for days in multiple rodent pain modelsFurtherthe antinociceptive effects of external pulsed HIFU on the DRG and its exiting nerve rootsENRsare dose dependent and have similar effects with repeated treatments in rodent modelsPostmortem histology reveals no damage to nerves or ganglion cells after treatmentThusthis is truly a neuromodulatory strategy rather than an ablative oneCurrentlyour device lacks the ability to visualize the target and directly monitor thermal effects at the targetIn this projectwe will develop a fully external HIFU system which can visualize the targetmonitor thermal energy delivery and provide treatment for chronic neuropathic painSpecificallywe aim to develop a state of the art directional noninvasive application specificsoft focusedHIFU device that is able to treat chronic neuropathic pain in the clinic within minutesAs we aim for this procedure to be done in the clinic under local anesthetic within minutes and to be completely externalwe will augment our existing device using a clinical diagnostic ultrasound imaging probe which can be used for image guidancetargetingand monitoring the therapy using quantitative ultrasound imaging techniquesThis capability will be integrated into our external HIFU device via an iterative process of simulation modelingbench testing and animal work in a swine neuropathic pain modelPhasestudies will be developed to culminate in a pilot first in man trial PROJECT NARRATIVE The economic burden of chronic pain in the U Sis staggeringIn the cases of medically refractory chronic neuropathic painneuromodulationsuch as spinal cord stimulationSCSis a non opioid based optionThough neuromodulation is typically electricalhere we examine an alternative with pulsed high intensity focused ultrasoundHIFUWe propose a fully external application specificsoft focusedHIFU device incorporating an integrated ultrasound imaging probe which can noninvasively pulse modulate thermal energy to treat chronic neuropathic pain and also guide monitor the therapy