Description:
OBJECTIVE: Investigate and validate the capability of using visual evoked potentials as a method to aid in the diagnosis mild traumatic brain injury. DESCRIPTION: In Iraq and Afghanistan, 12% of all warriors with battle injuries suffer from traumatic brain injury (TBI). The military"s need to diagnose and triage TBI casualties is described in the Theater Combat Casualty Care Initial Capability Document dated October 2007 and the Joint Force Health Protection Joint Casualty Management Joint Capabilities Document dated 11 June 2008. There is widespread agreement among subject matter experts that there is no clinically-validated predicate device for the diagnosis of mild TBI (mTBI). In addition, there is a need for the screening and management of treatment for acute and chronic moderate to severe TBI. Evoked potentials measure the brain"s electrical activity in response to stimulation and are generally used for studying higher cortical functions. Although they show promise, they are not routinely used in clinical neurology mainly due to advances in imaging technology, especially magnetic resonance imaging (MRI). An MRI typically gives more accurate information with regards to structural abnormalities but is not easily used in an austere environment, is more expensive, and does not have the capability to provide a rapid assessment of TBI. Visual evoked potentials (VEP) tests the function of the visual pathway from the retina to the occipital cortex and is used clinically ranging from glaucoma to classic and common migraines. The latency of visual evoked potentials has also been shown to have a positive correlation to intracranial pressure (ICP). An increase in ICP is a common secondary complication of TBI. Therefore, there is the potential of an easily portable device that can aid in the diagnosis of TBI through visual evoked potentials. It is the goal of this topic to explore the feasibility of developing a device that can meet the military"s need of a TBI diagnostic through the use of visual evoked potentials. The device should take into account the potential environment of use and be rugged enough to withstand extremes in temperature, shock and vibration, and humidity. The device should be sensitive and specific enough to provide a clear determination of TBI as characterized by a Glasgow Coma scale of 9-15 and be easily used (i.e. clear output indicator such as yes/no, stoplight, etc.). PHASE I: This Phase will demonstrate the feasibility of producing a device capable of aiding in the diagnosis of TBI by using VEP. This phase should include a plan for development, clinical validation, regulatory strategy, concept of the proposed device, and a literature search to support feasibility. PHASE II: Develop a working prototype based on Phase I work suitable for FDA clinical trials. Identify clinical sites for validation and primary investigators and have preliminary talks with FDA regarding regulatory path (at least pre-IDE, preferably IDE). Finalize pivotal trial protocol. PHASE III DUAL USE APPLICATIONS: There are clear commercial opportunities for a device that can correlate an easily measured signal to brain injury. The major military application is a device is to assess physiological impairment after exposure to blast or injury. The major civilian application is to assess physiological impairment after exposure to head injury during sporting events or other areas where concussions may be prevalent. Phase III of this project will look to conduct pivotal trials in these populations to show efficacy of the device. REFERENCES: 1. Gatz, Michael,"The Neurophysiology of Brain Injury,"Clinical Neurophysiology. 115, 4-18 (January 2004) 2. Evans, Andrew B and Boggs, Jane G,"Clinical Utility of Evoked Potentials,"Medscape Reference. (February 2012), http://emedicine.medscape.com/article/1137451-overview#a1 3. Padula, WV; Argyris, S;, and Ray, J,"Visual evoked potentials (VEP) evaluating treatment for post-trauma vision syndrome (PTVS) in patients with traumatic brain injury (TBI),"Brain Inj. 8(4), 125-133 (1994)
