Biotechnology company Medicortex Finland has started a clinical trial to detect mild Traumatic Brain Injury (TBI) and concussion in children and adolescents using rapid diagnostic kit ProbTBI.
As part of the trial, subject enrolment will take place at Satasairaala hospital in Finland over the coming months, collecting body fluid samples from young patients aged zero to 17 years with suspected moderate TBI.
The samples will be evaluated later against a specific biomarker signature following head injury.
Medicortex CEO Dr Adrian Harel said: “ProbTBI will be a highly innovative diagnostic kit for rapid detection of concussion. Children, in particular, will benefit from it since they can refrain from radiation or sedation which are needed for the CT scan of the head, as well as from exposure to other sick patients in the hospital.
“Participation of the young patients shortly after a head injury will be a challenge, but we have a committed and skilled clinical team working for us in the hospital.”
Medicortex states that the trial seeks to collect a sufficient number of pediatric samples to prove the applicability of the brain injury test in children, as a natural continuation for previously proven clinical performance in adults.
In January 2018, the company launched the Phase II clinical trial of ProbTBI diagnostic kit for TBI detection in adult patients.
Patients with mild brain injuries do not often show visible symptoms of brain damage.
Medicortex’s trial aims to develop examination and quality of treatment of brain injury in young patients.