Anyone who has parented a child with Attention-Deficit / Hyperactivity Disorder knows the chances of bringing their youngster to adulthood unscathed and concussion-free are about 50-50. Adults with ADHD often wonder later in life whether their “hard knocks” in childhood had anything to do with some of their current difficulties, but rarely have any way to find out.
But a new test just approved by the U.S. Food and Drug Administration could be the answer that ADHD families have been waiting for, at least in determining whether that “bump on the head” resulted in mild TBI.
The FDA has approved the first blood test to evaluate mild TBI (mTBI) or “concussion” in adults.
A “mild traumatic brain injury” can be classified as such if loss of consciousness and/or confusion and disorientation is shorter than 30 minutes, according to Traumatic Brain Injury.com. Mild traumatic brain injury (mTBI) can be difficult to diagnose and particularly frustrating to diagnose and deal with on a day-to-day basis.
The new test, called the Banyan Brain Trauma Indicator, works by measuring levels of two proteins UCH-L1 (ubiquitin C-terminal hydrolase L1) and GFAP (glial fibrillary acidic protein) that are released from the brain following a head injury and which appear in the blood within hours.
TBI is caused by a bump, blow or jolt to the head or a penetrating head injury that disrupts the brain’s normal functioning. Its severity may range from mild to severe, with 75 percent of TBIs that occur each year being assessed as mTBIs (mild traumatic brain injuries) or concussions.
The problem is, a majority of patients — 90 percent — who come to the emergency room with concussion symptoms have a negative CT scan, according to Banyan Biomarkers, Inc., the developer of the Brain Trauma Indicator.
Potential effects of TBI can include impaired thinking or memory, movement, sensation or emotional functioning.
Most patients with a suspected head injury are examined using a neurological scale, called the 15-point Glasgow Coma Scale, followed by a CT scan (computed tomography) of the head to detect brain tissue damage or intracranial lesions that may require treatment.
A majority of patients evaluated for mTBI/concussion do not have detectable intracranial lesions that are seen on a CT scan.
Availability of a blood test for concussion will help health care professionals determine the need for a CT scan in patients suspected of having mTBI and help prevent unnecessary neuroimaging and associated radiation exposure to patients, the FDA said in a Feb. 14, 2018 news release.
“A blood testing option for the evaluation of mTBI/concussion not only provides health care professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases,” said FDA Commissioner Scott Gottlieb, M.D.
According to the U.S. Centers for Disease Control and Prevention, in 2013 there were approximately 2.8 million TBI-related emergency department visits, hospitalizations and deaths in the U.S.; of these cases, TBI contributed to the deaths of nearly 50,000 people.
The FDA evaluated data from a multi-center, prospective clinical study of 1,947 individual blood samples from adults with suspected mTBI/concussion and reviewed the product’s performance by comparing mTBI/concussion blood tests results with CT scan results. According to the FDA, the Brain Trauma Indicator was able to predict the presence of intracranial lesions on a CT scan 97.5 percent of the time, and those who did not have intracranial lesions on a CT scan 99.6 percent of the time.
“These findings indicate that the test can reliably predict the absence of intracranial lesions and that health care professionals can incorporate this tool into the standard of care for patients to rule out the need for a CT scan in at least one-third of patients who are suspected of having mTBI,” the FDA noted.
The results of the test are available within three to four hours.
Photo: Pixabay / Jarmoluk