Development of a Device to Objectively Measure Pain (R43/R44)

Purpose:

The purpose of this Small Business Innovation Research (SBIR) Funding Opportunity Announcement is to develop a technology/device that objectively indicates the presence and level of pain.      

Background

This goal of this RFA is to encourage Small Business Concerns (SBCs) to develop a tool to objectively measure pain for research or clinical purposes.  Historically, pain in humans has been measured using subjective ratings, such as the visual analog scale (VAS), to determine presence and severity.  A person simply says how much pain they are experiencing, with verbal descriptors, a scale, images depicting pain levels and the like.  While this is important information, self-report is a problematic metric for both diagnostic and research purposes.  A person’s self-report depends on their history with pain, and other cognitive and behavioral factors, and can vary over time.  Further, comparisons between people reporting their pain is impossible to do with confidence. There simply is no way to know if what one person calls a given level of pain corresponds to what another person describes as the same pain.  Further self-report is impossible to obtain in various populations, like the very young, people with various disorders that interfere with communication, and the unconscious.  Recently, various survey-based metrics of pain and function have been developed, which have improved utility. However, they still are based on self-report and thus still carry some of the same issues as simple self-report measures.  

Over the past few years, significant advances have begun to be made in the development of particular measures as valid biomarkers or surrogate markers for the presence of acute and/or chronic pain.  Many of these advances have been made because of the development of new and improved technologies, for example in the fields of imaging and genetics.   Research is now showing brain activity and brain organizational changes associated with the presence of pain.  Various factors have been found in the blood that are associated with the presence of pain.  Research is also suggesting that pupil responses to a variety of stimuli may predict the presence of pain.  And machine learning analysis of videos has found facial movement patterns in both animals and humans that are correlated with the presence of pain.  

It now appears feasible to develop clinical tools that can measure biomarkers or surrogate markers for the presence of acute and/or chronic pain. Such an objective tool would allow for an improvement in clinical pain research and treatment.  Currently, there is an urgent need for personalized treatment options for people in pain that do not rely heavily on opioids.  However, pain research and diagnosis of pain are hampered due to the lack of objective measures of pain.  Clinicians do not merely rely on a patient’s subjective estimations of core body temperature, blood pressure or heart rate; similarly they should not rely on only subjective measures of pain.  Quality research and treatment require quality measurement.  It is likely that these tools could improve both pain research and pain treatment.  

Research Objectives

This initiative is to encourage the development of a technology/device that validly indicates the presence and level of pain.  These tools could additionally help to measure:

• The original or type of pain (e.g. nociceptive, neuropathic, centrally mediated…).
• The type of treatment that might be most effective in alleviating pain.
• Whether opioids might be useful versus if it may present significant risks. 

This technology/device should be affordable and usable within many clinical settings including primary care.  There have been many recent advances in measuring variables that predict if a person is in chronic pain, including blood factors, facial expressional, and eye reactivity.  The new technology could measure some of these variables, or other appropriate variables.  

Phase I Activities

Phase I activities includes, but is not limited to the development of the initial prototype and feasibility studies that demonstrate the validity of specific biomarkers or surrogate markers for the presence of acute and/or chronic pain. Testing should demonstrate that the device can accurately detect and/or quantify the level of chronic or acute pain and identify and distinguish false negatives (e.g. patient acting to be in pain vs. actual pain). In addition, a patient’s willingness and level of comfort may also be included in initial prototype evaluations. Overall, Phase I actives must clearly test the underlining hypothesis and demonstrate feasibility, not utility, to such a degree that movement to Phase II is considered a reasonable next step. Specific Aims must have clear, quantifiable milestones. 

Phase II Activities

Upon completion of Phase II activities, it is envisioned that the company will have a device which would be ready for testing with a suitable population to demonstrate data suitable for FDA consideration. The company should provide evidence of a likelihood to obtain additional capital commitment from the private sector or other non-SBIR funding sources to move the product toward the market.  

See Section VIII. Other Information for award authorities and regulations.