Typically, a neurological clinical assessment to detect a brain disorder can take anywhere from 15 to 20 hours, says occupational therapist Tracy Milner.
Over the years Milner, whose specializes in neurorehabilitation and has worked with people with mild to severe brain injuries, realized that a mobile, portable assessment is required that can capture how that brain disorder is affecting patients’ everyday life and be sensitive enough to detect even minor impairments.
Thus Milner, along with co-founder Heather Condello, also an occupational therapist, launched BrainFX. The health IT start-up is developing a Web- and tablet-based software – BrainFX 360 – that tracks brain function over time by recording a base line performance of an individual with which future results can be compared.
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The assessment has two parts. The first one can be completed online by the patient who is at risk of brain injury, suspected of having one or already has one in about 20 minutes. That involves a medical history with questions about mood, behavior, sleep, diet and physical symptoms, among other things, Milner said in a recent interview. Family members or caregivers also can fill out the online portion of the assessment, provided the patient gives permission.
The second part of the assessment is tablet-based and is administered by a health professional. The health professional also needs to be certified by BrainFX to administer the test. The tablet-based assessment – only available on Android devices – makes the patient do 50 activities that measures 30 cognitive skills.
For instance, one screen shows a list of four or five items that a person needs to remember to buy on the way home. Several screens later the software prompts the patient to name the items. At the end of the assessment, patients have the option to email it or print it to take to their doctor.
The assessment can be done before football season for instance. Concussions and brain injuries are innate to the rough game and the test can be administered again following an injury. It is also useful for combat soldiers and veterans, Milner said to track their cognitive ability over time.
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One of the biggest advantage, of course, is that the assessment is much faster – one hour compared with the 15 – 20 hours for a neurological test. The portability and ability to create a profile on BrainFx where multiple assessments can be scored revealing how the brain is functioning over time is a key benefit as well.
“It really gives the people the information they need to make informed decisions,” Milner said. “They know what their strengths and challenges are.”
BrainFX will be launched in April and the first human trials will begin in two weeks. The 300-patient study will involve 150 who have been diagnosed with a concussion or brain injury while the other half are healthy. The study will conclude in March.
BrainFX also intends to open an office in Boston next year, with another two U.S. locations – potentially in Minnesota and the West Coast planned for the future, Milner said.
She is also hopeful that the solution that she and her team have come up with will be able to address the $1.3 trillion cost that is incurred annually in the U.S. due to brain-related healthcare costs and lost income.
The company’s success, however, will depend on how much market share it can take away from standard methods of clinical testing, especially the imPACT test, which offers baseline testing of athletes and has been widely adopted. Screening tests like imPACT that offer such baseline comparison were not available even five years ago, said Keith Cronin, a St. Louis, Missouri,physical therapist and center manager at SSM-Select Physical Therapy, in a previous interview.
Milner suggests that the imPACT test has real flaws.
“Recent studies have shown that it has a 20 to 30 percent false negative and a 20 to 30 percent false positive rate,” she said. “Neuropsychological tests say that a player should not play and the imPACT tests say play.”
[Fractured brain image from BigStock]
