Brainscope

BrainScope’s clinical trials are crucial in validating the clinical safety and effectiveness of all BrainScope products. BrainScope utilizes clinical trials to support the following product development objectives:

• Regulatory requirements for product registration;
• Test scientific and technical hypothesis as part of the product development process, and;
• Demonstrate clinical utility and product differentiation for product marketing efforts.

Currently BrainScope prototype devices are being used in clinical data collection sites in emergency departments at ten leading United States hospitals since 2005. BrainScope prototype devices used for clinical research meet “non-significant risk” (NSR) criteria as established by FDA Guidance 21 CFR 812.2(b).  All BrainScope clinical trials receive local Investigational Review Board (IRB) approval and require informed consent from the subject.

Clinical Trials in Progress:

Concussion in the Emergency Room Trial (ConcERT):

• Use of the BrainScope EEG for the identification and prognostication of Emergency Department patients with concussion and mild traumatic brain injury.

TBI – Moderate/Severe:

• Use of Electrophysiological Imaging in the Emergency Room: Early Detection of Brain Dysfunction

Future Clinical Trials:

BrainScope will soon announce details of future clinical trials.

Publications:

Preliminary findings of the data collected with the BrainScope prototype device have been presented at medical and scientific assemblies and published in peer-reviewed medical and scientific journals.