US-based medical device firm Neural Analytics has begun patient enrolment for a clinical study of its Lucid M1 Transcranial Doppler (TCD) Ultrasound System to monitor patients with mild traumatic brain injury (TBI).
The Lucid system is developed as an ultrasound system to measure and display cerebral blood flow velocities, as well as to monitor brain disorder patients.
It employs the Transcranial Doppler (TCD) ultrasound to analyse blood vessels in the brain from outside the body.
The two-year study will utilise the system to develop a method for assessing cerebral blood flow in TBI patients and will include 240 subjects who will be divided into mild TBI, 'In Sport' control and Out of Sport control groups.
In Sport controls will comprise subjects associated with high-risk contact sports such as football and hockey, while Out of Sport controls will include low-risk contact sports such as baseball and tennis.
Neural Analytics co-founder and chief scientific officer Robert Hamilton said: “There’s a need for a definitive method for mild TBI assessment, in particular for determining if a patient is ready to return to playing after a sports concussion, especially in high school and college athletes.
“Findings from this study may help inform physicians on return to play decisions.”
Designed to include injury and return-to-participation (RTP) components, the study will primarily focus on new method development for quantification of common post-mild TBI physiologic changes such as impairment of autonomic function and altered cerebral blood flow (CBF).
In the study, the cerebral hemodynamic impairment measured using the Lucid System will be compared to clinical evaluations and magnetic resonance imaging (MRI) techniques.