Biopharmaceutical firm Prevacus has selected FDA-cleared BrainScope One device to use in its upcoming study on concussion, a mild traumatic brain injury (mTBI).
Prevacus will use the BrainScope One device in its Phase 1b clinical research study as an objective biomarker of brain function.
BrainScope One system offers multi-dimensional assessment of brain function, comprising electroencephalography (EEG) measures, cognitive performance tests, and standard, digitized concussion assessment tests to assist in standardizing data collection across clinical sites.
The system offers an objective EEG measure known as brain function index, which can be used to evaluate the functional injury component of the brain after an injury.
BrainScope clinical affairs vice president Douglas Oberly said: “We are excited to see BrainScope One’s capability being used to provide clinical data points to study Prevacus’ new and innovative drugs as an alternate line of therapies for traumatic brain injury.”
BrainScope One system evaluates traumatic brain injury, including concussion, by using digital EEG along with other modalities, directly on the handheld device, facilitating decision-making for first responders, clinicians and other health practitioners.
The system also provides objective data to the pharmaceutical researchers, helping them to confirm inclusion criteria after initial head injury.
A concussion is a type of traumatic brain injury occurred due to significant force to the head or upper body causing the brain to shake inside the skull.
The injury will be noted as concussion when it causes a change in mental status such as amnesia, disorientation, mental fogginess, confusion, nausea/vomiting, blurred vision, headache, balance deficits or loss of consciousness.
Prevacus CEO Jake VanLandingham said: “BrainScope One will provide significant assistance during our upcoming phase 1b study.
“We are grateful for their support in pursuit of discovering a solution to concussions for our athletes, military personnel and all other at risk groups.”