COGNISION - Biomarker
COGNISION® is cleared by the FDA. COGNISION® is an objective biomarker system that offers clarity in a field of complexity. By facilitating an objective evaluation of patients with cognitive disorders, COGNISION® helps neurologists and other physicians differentiate between dementia and depression, track disease progression and assess overall cognitive deficits associated with dementia and concussion/mTBI.
Is it dementia or depression? Is the patient ready to return to their environment post head injury? COGNISION® helps physicians answer these questions and more by objectively measuring cognitive deficits and providing physicians with the clarity they need to better care for their patients.
By placing the device headset on the surface of the scalp, COGNISION® measures electrical activity in the brain responsible for cognitive function. The device rapidly evaluates working memory, focal attention, executive function and brain processing speed through Event Related Potential (ERP) and quantitative EEG (qEEG) tests. A real-time, ready-to-read patient report is produced at the end of the testing session.
- Differentiating dementia from depression
- Detecting deficits in the brain early in the disease process
- Tracking disease progression over time
- Demonstrating medications are working
- Facilitating better return to environment decisions post head injury
- Predicting disease course and outcome after a concussion or TBI
COGNISION® set up takes 10 minutes or less. Any technician can be trained in less than 3 hours and there are no upfront acquisition costs.
- Portable, wireless operation, and can be used in any clinical setting
- Advanced active electrodes that produce high-quality data in any testing environment
- Convenient HydroDot® biosensors designed for easy, rapid set-up with minimal clean-up
- Subject-friendly headset fits a range of head sizes
- No upfront acquisition costs
Clients from around the country have successfully received reimbursement from both Medicare and commercial payors. Clients are charged on a per-test basis.
One of the main challenges in the development of effective pro-cognitive treatments is the ability to accurately assess the level of a patient’s cognitive dysfunction or any pro-cognitive changes due to therapeutic intervention.
Thanks to the latest electronic sensor design, advanced signal processing, and web-based data management, ERP and qEEG testing can now provide objective, sensitive and reliable physiological measures of cognitive function that can be practically applied throughout the drug development process.
COGNISION® makes implementation of ERP and qEEG testing in clinical trials practical and scalable through a fully integrated hardware/software platform.
COMPLETE FLEXIBILITY IN TEST DESIGN
COGNISION® allows for testing protocols tailored to the investigational drug mechanism of action and/or cognitive deficits specific to the target population.
EASY AND FAST SET UP
COGNISION® is practical to operate even for users with minimal electrophysiology training, thus providing maximum flexibility in clinical study sites selection.
CONSISTENT RESULTS ACROSS CLINICAL STUDY SITES
COGNISION® uses advanced active electrodes that produce high quality data in any testing environment, ensuring consistent data quality across clinical study sites and reducing inter-site variability.
WRITES CLINICAL PROTOCOLS IN REAL TIME
COGNISION® automatically loads new protocols in real time, can quickly run additional protocols within the same system and has strong test and re-test reliability.
RESULTS ARE AVAILABLE REAL TIME
COGNISION® provides automated data analysis that allows for rapid evaluation of treatment effects when needed, such as in adaptive studies.
AVAILABLE FOR GLOBAL CLINICAL TRIAL USE
COGNISION® can be used at any number of test sites and has facilitated large-scale global clinical trials as far away as Australia, Tasmania and New Zealand.
CENTRALIZED STORAGE OF DATA
COGNISION® uses cloud-based software for data sharing that provides authorized study personnel with centralized access to data and documents in multi-center studies.
- Primary physiologic measure of the synchronous, large-scale synaptic activity underlying all brain functions
- More proximal to disease pathology and pharmacological intervention than psychometric measures
- Sensitive to many of the effects of psychotropic or acute-acting CNS compounds
- Unaffected by habituation and can be measured repeatedly without learning effects
- Sensitive measure of disease progression for monitoring chronic conditions
- Translational measures with direct animal/human correlates
Cognitive psychology and clinical neuroscience disciplines aim to understand how the brain processes information. While human cognition researchers have access to a broad range of technologies, the most direct way to measure many fundamental cognitive processes is by using COGNISION®. COGNISION® uses quantitative EEG (qEEG) and Event Related Potential (ERP) tests to record and analyze the brain’s electrical activity, both at rest and when responding to external stimuli.
COGNISION® facilitates complex qEEG and ERP testing through a platform that has many unique benefits when compared to other systems. Advantages include:
- High-quality data available in any testing environment
- Convenient biosensors designed for easy, rapid set-up with minimal clean-up
- Portable, wireless operation that can be used in any clinical setting
- Sophisticated protocol development application for flexible test design
- Automated data analysis for rapid evaluation of test results
- Cloud-based software for data sharing in multi-center studies