There are currently no tools available that can objectively measure pain. Historically, pain in humans has been measured using subjective ratings to determine presence and severity. In animal models, pain is measured by semi-quantitative assays that rely on the observation of pain behaviors. Though useful, the inherently subjective nature of these measures has hampered both research and treatment efforts. Simply put, inaccurate pain measurement leads to inaccurate pain management. Overtreatment and addiction to pain medications are a continuing epidemic in the U.S. The estimated economic burden of chronic pain is estimated to exceed $600 billion. One advantage of an objective pain measuring technology is cost reduction. The average cost to treat a chronic or neuropathic pain patient is $19,000 per year. These costs are exaggerated because many patients have inadequately managed pain, which requires disproportionately more resources. A significant portion of these costs go to patients who are not experiencing substantial pain; e.g. those who abuse opioids. Another area where costs could be significantly reduced is in drug development. The average pain clinical trial cost is around $71 million. The use of a pain imaging technology would allow for objective efficacy data (both pre-clinically and in clinical trials), and reduce costs by enabling smaller sample sizes due to more homogeneous populations; i.e. with a particular âpain signal,â and more accurate measurement of analgesic effects. We recently invented a novel positron emission tomography (PET) imaging agent that we developing as a tool to address these issues in pain care and therapy development. Although the ability of PET to detect pathological changes for (early) disease detection is widely used in cancer and neurological diseases, it has not yet been used for pain indications. We have tested this molecule in healthy rats and non-human primates and found a strong signal to background ratio in nerve tissue. Our ultimate goals are: 1) to change the evaluation of (experimental) pain therapies, and 2) the standard of care in pain assessment through molecular imaging. The proposed study is designed to determine the feasibility of our imaging agent to objectively measure pain in rodents. This will set the stage for a Phase II study that further develops this agent into a tool for quantifying pain/analgesia.
Public Health Relevance Statement: Project Narrative Voltage-gated sodium channels (NaVs) are centrally involved in pain transmission, including aberrant function and expression levels leading to hyperexcitability. We recently invented the first positron emission tomography (PET) ligand for quantifying pain. The goal of this Phase I project is to determine the feasibility of this ligand as a technology that objectively and reliably indicates the presence and level of pain in a preclinical study.
NIH Spending Category: Biomedical Imaging; Chronic Pain; Neurosciences; Pain Research
Project Terms: Absence of pain sensation; Acute; Acute Disease; Acute Pain; addiction; Address; Adult; allodynia; American; Analgesics; Animal Model; Animals; Area; base; Basic Science; Behavioral; Binding; Biological Assay; Caring; Chronic; chronic pain; Clinical; clinical pain; Clinical Trials; Cognitive; Communication; cost; Data; density; Descriptor; design; Detection; Development; Diagnostics Research; Disease; drug development; Economic Burden; efficacy study; Epidemic; Evaluation; Evolution; Exhibits; experience; experimental study; Goals; Human; human subject; Image; imaging agent; Imaging technology; improved; in vivo; Infrastructure; injured; Injury; Knowledge; Lidocaine; Ligands; Ligation; Malignant Neoplasms; Measurement; Measures; Medical Research; Modeling; molecular imaging; Morphine; Nature; Nerve Tissue; nervous system disorder; Neurons; nonhuman primate; novel; novel therapeutics; Operative Surgical Procedures; Opioid; opioid abuse; overtreatment; Pain; pain behavior; Pain management; Pain Measurement; pain model; pain patient; pain reduction; pain signal; painful neuropathy; Pathologic; Patient Self-Report; Patients; Persons; Phase; phase 2 study; Population; Positron-Emission Tomography; pre-clinical; preclinical study; Rattus; Recording of previous events; Reporting; Research; research facility; Resources; Rodent; Sample Size; Severities; Signal Transduction; Sodium Channel; Spinal; Spinal Cord; spinal cord imaging; Spinal nerve structure; standard of care; Surveys; Tactile; Target Populations; targeted treatment; Technology; Testing; therapy development; Time; Tissues; tool; transmission process; Unconscious State; United States National Institutes of Health; voltage; Western Blott
