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Trial Testing Biomarkers as Brain Injury Diagnostics

Brain map illustration

(Arthur Toga, UCLA/NIH.gov)

29 December 2017. A clinical trial is underway in Finland testing the ability to detect traumatic brain injuries with simple blood, urine, and saliva tests. The company Medicortex Finland Oy in Turku said yesterday the intermediate-stage trial enrolled its first patient.

Medicortex Finland is developing a technology to diagnose concussions and other mild traumatic brain injuries, where in many cases people with these injuries do not exhibit symptoms. Quick detection of concussions can prevent those injured, such as athletes in contact sports or victims in auto accidents, from aggravating their injuries, leading to debilitating neurological disorders, such as Parkinson’s disease, epilepsy, or chronic traumatic encephalopathy.

In a paper in the journal eNeuro published late in 2016, Medicortex’s founder and CEO Adrian Harel and colleagues outlined the case for for chemical detection of traumatic brain injuries, instead of evaluation of symptoms or imaging, which can produce ambiguous results. The authors identified 12 biomarkers of traumatic brain injury, most of which are elevated for a short time following the injury’s occurrence.

The clinical trial is recruiting 160 participants at a hospital in Turku. In the first part of the study, up to 60 individuals will be recruited with a suspected head injury, a bone fracture other than the skull, and healthy volunteers with no history of head trauma. People with suspected head injuries will be asked to give up to 5 blood, urine, and saliva samples over a 1-year period, while people with bone fractures and healthy participants, will be asked for  a single round of blood, urine, and saliva samples for comparison.

In the study’s second phase, up to 100 more people with concussions or traumatic brain injuries will be enrolled, also taking blood, urine, and saliva samples and tracked for a year. All samples will be analyzed with the Medicortex test kit and high-performance liquid chromatography to identify the characteristic biomarkers of traumatic brain injury.

Medicortex completed in May 2017 an earlier clinical trial to prove the concept of traumatic brain injury biomarker detection. That study recruited 12 participants with suspected head injuries, who provided fluid samples that showed the presence of characteristic biomarkers, while volunteers without head injuries did not. Based on those results, Medicortex developed its ProbTBI test kit, which is being evaluated in the new trial.

Mårten Kvist, Medicortex’s medical director, says in a company statement, “Medicortex plans to quickly advance its second clinical trial to confirm the promising findings of its previous proof-of-concept study. Such a diagnostic tool is truly awaited and it will considerably improve the possibilities to detect a traumatic brain injury in patients who are suffering from symptoms caused by a hit to the head.”

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