Researchers from Florida Atlantic University's Schmidt College of Medicine, in collaboration with Albany Medical College (AMC) in New York, are among seven institutions nationwide selected to receive funding from the National Institutes of Health (NIH) for their innovative pilot projects to enable new medical devices to diagnose and treat both acute and chronic disorders from neuropathic pain to mental illness.
The one-year, $100,000 awards are the first for a new program within the NIH Blueprint for Neuroscience Research, called Blueprint MedTech. The seven projects selected for the pilot phase for funding by the NIH all received successful reviews from ABC's "Shark Tank."
Along with funding, MedTech will provide an array of specialized support from mentors who bring decades of experience commercializing neurotechnology devices. Project teams will learn to navigate business, manufacturing and regulatory aspects of developing their respective technologies, and prepare to build human-grade prototypes. While the science supporting each technology has met rigorous standards, clinical studies will be needed prior to their authorization for use in patients.
The FAU/AMC project is titled "External Low-intensity Focused Ultrasound Device for Treatment of Neuropathic Pain." Focused ultrasound is a noninvasive therapeutic technique that directs ultrasonic waves to a specific location. For the project, researchers are developing a handheld probe to provide a noninvasive, non-opioid-based treatment for aggravated chronic pain, also referred to as neuropathic pain, for use in a physician's office or potentially even at home.
The device directs low-intensity ultrasound at the dorsal root ganglia – small bundles of nerves along the spine that control pain signals reaching the spinal cord. Neuropathic pain occurs if the nervous system is damaged or not working correctly. Pain is felt from any of the various levels of the nervous system from the peripheral nerves to the spinal cord and the brain.
Pain is one of the most common reasons patients seek medical care. Importantly, neuropathic pain, when treated with opioid-based drugs, has led to addiction in some patients. In addition to medications such as opioids, traditional treatment of pain also involves physical therapy and steroid injections. However, adverse effects and tolerance occur with many of these therapies and a significant number of patients remain in pain. There is a great unmet need to provide more effective, safer and financially sustainable therapies for patients in pain."
Julie Pilitsis, M.D., Ph.D., FAU's principal investigator, dean and vice president for medical affairs in the Schmidt College of Medicine
The handheld applicator under development integrates ultrasound imaging and therapy and is designed to accommodate differences in human anatomical size. As a result, the treatment device and methodology will provide means for precise treatment of back and leg pain.
"It is the noninvasive aspect and all-in-one nature of our device that is highly significant as an advancement in treatment of neuropathic pain," said Pilitsis. "The cost of pain therapies and missed wages secondary to pain results in about $536 million dollars spent each year. Ideally, with this therapy, patients can avoid hospitalization and days off work by reducing pain and enabling function."
Over the last eight years, the FAU/AMC researchers have shown efficacy of low intensity focused ultrasound in alerting nociceptive responses related to the perception or sensation of pain in multiple pain models over multiple species in both sexes and with repeated treatments.
As part of this new project, Pilitsis and collaborators will conduct a small pilot study to show safety and feasibility of the low-intensity focused ultrasound device. After obtaining an Investigational Device Exemption from the United States Food and Drug Administration (FDA) and Institutional Review Board approvals, researchers will recruit patients from Boca Raton with lower extremity pain for the pilot study.
Blueprint MedTech is an NIH incubator that aims to address challenges that innovators contend with in the process of developing cutting-edge medical devices to diagnose and/or treat disorders of the nervous system. It is a constituent program of the NIH Blueprint for Neuroscience Research, a cooperative effort among the NIH Office of the Director and 12 of the NIH Institutes and Centers that support research on the nervous system. By pooling resources and expertise, the Blueprint supports transformative neuroscience research, and the development of new tools, training opportunities, and other resources to assist neuroscientists.