::::::::: DETECT™ ::::

Rapid system for detection and monitoring of cognitive impairment
::::::::: Pain ::::

Repeat or underdiagnosed concussion is emerging as a significant sports medicine problem, that if
not recognized may lead to prolonged cognitive and emotional impairment later in life as seen in today’s
headlines. Detecting mild traumatic brain injury (mTBI) early and making return to play and treatment
assessment on the field or immediately after a game can be key to reducing these problems, especially in younger players.
Alzheimer’s disease is a progressive disease that is increasing in prevalence with the aging population. There is no cure.
New drugs however have proven effective in delaying onset of symptoms. Effective therapy depends on early assessment
and diagnosis. Current methods rely on lengthy, labor intensive, neuropsychological tests that require unique knowledge
and skill for interpretation. As a result, therapy is not instituted when it is most effective in many patients.
::::::::: Solution ::::

Through its ease-of-use, rapid testing protocol and immersive test environment, DETECT™ enables early
assessment of cognitive decline and initiation of therapy if warranted in the use for early Alzheimer’s disease detection. For sports mTBI usage DETECT™ can be useful to coaches and trainers for return to play vs. treatment decisions. The system is an integrated hardware/software solution that can be administered by non-skilled personnel in environments normally not
suitable for cognitive testing. Results are compared to previous test results and to a national database. When cognitive issues are detected, patients may be referred for specialist follow-up. DETECT™ can be used in the rehabilitation and home
settings, as well, alone or in conjunction with other cognitive assessment and therapy tools.
::::::::: Technology ::::

The DETECT™ system comprises both hardware and software components to create an immersive environment and
administer a series of abbreviated neuropsychological tests. Hardware consists of a unique dedicated mobile
computer, and an integrated headset consisting of a heads-up display, earmuffs and adjustable visor, and an input
device. Three software modules complete the system: testing modules, a database for archiving and retrieval of test
results and a central server for uploading test results and downloading the latest population norms.
::::::::: Alternatives ::::

Manual and computer-based cognitive scoring systems exist that, for lack of better alternatives are used but are
expensive to administer and time consuming. None of the competitive systems have the potential for standardization
that results from the DETECT™ immersive environment. Standardization permits comparison of same-individual test
results across time periods as well as comparison of test results to a match database. Nor do any potential competitors
create an environment that is feasible for conducting sideline assessment.
::::::::: Device Development & Clinical Studies ::::

Benefiting from 5 years of grant funding, technical feasibility of the system has been demonstrated. Several
prototypes have been developed and tested. Final design changes are being implemented.
Initial clinical feasibility in patients with mild cognitive impairment has been demonstrated. Three clinical studies have
been completed. The first was the validation of the immersive environment created by the system. Testing scores were
not affected in a simulated noisy environment. The second study tested the feasibility of sideline assessment of
concussion in college football and provided preliminary data on the detection of concussion. Pre-season baseline (87
baselines) testing and post injury (5 concussions) was feasible. Pilot data shows impaired reaction time in concussed
players. The third pilot study (40 patients) demonstrated that the device could differentiate between patients with MCI
and normal controls. The fourth study included over 400 patient 65 and older. This study demonstrated that the device
could be used for MCI screening in a population of geriatric patients and can detect MCI almost as well as the lengthy
standardized testing.
::::::::: Clinical Integration ::::

For screening of MCI and early Alzheimer’s disease, the device will be provided to general practice clinics for annual
screening of cognitive impairment of patients 50 years and older. The purpose of beginning testing at 50 years of age
is to obtain normative baselines. Although baseline testing is not required to detect abnormalities, it will be more
sensitive and allow physicians and patients to track their cognitive health. An abnormal cognitive decline would
constitute the onset of MCI.
For TBI screening and sidelines assessment of concussion, the device can be used by schools, school systems and
other sports organizations. Preseason/pre-sport norms can be obtained and used to compare to post injury, creating and
internal control and norm. The device will provide the team coaches and trainers with an objective measurement of
concussion induced cognitive dysfunction.
