Clinical Diagnostics HEADING_TITLE

The COGNISION™ System has been developed to provide clinicians a direct physiological measure of the cognitive dysfunction associated with a range of neurological disorders including:

  • Alzheimer’s Disease
  • Mild Traumatic Brain Injury (concussion)
  • Attention Deficit Hyperactivity Disorder
  • Schizophrenia
  • Down Syndrome
  • Autism Spectrum Disorders and Learning Disabilities

These bioelectric measures of brain processing can be used to help diagnose cognitive dysfunction, monitor the course of the disorder, and track the effects of treatment.

Currently, most clinicians must rely on psychometric and behavioral testing to evaluate these conditions.  This kind of subjective testing is often unreliable because it involves vague self-assessment feedback and uncertain clinical interpretation.

More advanced diagnostic technologies, such as cerebral spinal fluid analysis or brain imaging are expensive, invasive, and limited to hospital settings.  And even so, do not provide information about the cognitive deficits associated with neurological disorders.

COGNISION™ has been designed to overcome these limitations.  The tests can easily be performed in an office setting, provide immediate feedback to the clinician, and are covered under existing procedure codes.

 

Alzheimer’s Disease


The only way to overt this pending calamity is to develop effective treatments for the cognitive dysfunction associated with these diseases that would allow elderly dementia sufferers to remain independent for a longer time which will delay their placement into assisted living facilities.  Early detection of the cognitive deficits associated with Alzheimer’s disease is critical for interventional therapies to be successful.There are currently over 5.4 million Americans who suffer from Alzheimer’s disease. With over 500,000 new cases diagnosed every year, this population is projected to grow to 14 million by 2050.  Alzheimer's disease and other dementias cost the United States over $200 billion in healthcare costs annually and this cost is expected to  increase dramatically over the next few years.

COGNISION™ was developed specifically to address the dementia market and was 
initially validated in a large multi-center clinical study with mild Alzheimer’s patients.  The system can also play a critically strategic role in therapeutic development by measuring the beneficial cognitive effects of Alzheimer’s therapeutics. (See Pharmaceutical Development).

 

Mild Traumatic Brain Injury (MTBI)

Mild Traumatic Brain Injury is a condition caused by a rapid acceleration of or an impact to the brain, resulting in a concussion.  There are at least 1.4 million occurrences of TBI in the US each year.  MTBI is common in athletic and military activities such as football, hockey, and para jumping.   Sustaining a second concussion before the cognitive effects of the first concussion subside can result in significant long-term damage.  Furthermore, multiple concussions sustained over time may result in severe neurodegenerative disease.

A US Army Research Command recently stated that there are, “no objective, clinical tools available to provide an accurate diagnosis of mild brain injury.”  Although there are tools, such as neuro-imaging,  available to the clinician to identify the incidence of severe traumatic brain injury, their diagnostic value is limited in mild cases.  Clinicians are forced rely on patient self-assessments and clinical observations which are subjective, can be highly inaccurate in the pre-hospital setting, and not sufficiently sensitive for mild brain injury. 

COGNISION™ can provide a physiological measure of cognitive dysfunction which is not subject to language/communication barriers, interview biases, or other behavioral confounds.  Data collected with the system can indicate when a concussive event has occurred, the severity of the cognitive deficit, and when the cognitive effects of the injury have subsided. 

Attention Deficit Hyperactivity Disorder (ADHD) 

ADHD is a neurological disorder that affects a person's ability to pay attention to tasks and control their behavior. Estimates are that between 8% and 10% of school-age children have ADHD.  Billions of dollars are spent annually on prescription medications for these patients.  There is increased concern among some doctors, parents, and child advocates that many children are taking ADHD medication unnecessarily.  Not surprising, several ADHD drugs are on the government’s list of, “Most Abused Drugs.”

Consequently, clinicians are under pressure to tighten up on their prescribing methodologies by performing more objective diagnoses.  However, the primary diagnostic method used by physicians to prescribe ADHD drugs is based on interviewing the patient or patient’s caregiver and relying on their feedback.  To date, there are no objective, physiological diagnostic tools available for ADHD, even in the hospital setting.

With COGNISION™ clinicians can now get a direct physiological measure of the aberrant cognitive processes associated with ADHD.  This test is complimentary to current diagnostic methods and is not subject to self-reporting bias.  In addition, COGNISION™ provides direct cognitive measures that can be used by pharmaceutical companies to facilitate the development and validation of ADHD therapeutics. (See Pharmaceutical Development)

Schizophrenia

There are an estimated 25 million people in the world with schizophrenia.  The disorder contributes to chronic problems with behavior, emotion, and significantly effects cognition.  There are no objective, physiologic diagnostic tests for schizophrenia.  Diagnosis is based on the clinician’s observations and the patient's reported experiences.

People suffering from schizophrenia have an average reduction in life expectancy of 12-15 years.  There has been increasing interest in the early detection and intervention during the prodromal phase of this disorder.  Intervening earlier results in the greatest opportunity to enhance clinical outcomes and delay or prevent the onset of the disorder.

For several decades, an electrophysiologic signature of schizophrenia has been known in academic research.  However, the complex research-oriented hardware and methods have prevented this test from being adopted in the clinic.  COGNISION™ was developed to overcome these problems and was designed specifically to be used in the clinician’s office to perform the same test for schizophrenia that has been validated in research labs.  In addition, COGNISION™ provides direct cognitive measures that can be used by pharmaceutical companies to facilitate the development and validation of schizophrenia therapeutics.  (See Pharmaceutical Development)

Down Syndrome

Down syndrome is a genetic disorder that typically results in a delay or deficit in cognitive abilities.  COGNISION™ is currently being used to measure the cognitive effects of drugs under development to treat people with the disorder.  (See Pharmaceutical Development)

Autism Spectrum Disorders and Learning Disabilities

Autism spectrum disorders and learning disabilities such as dyslexia and central auditory processing disorder (CAPD) are often associated with cognitive dysfunction.  Event-Related Potentials (ERP) and Quantitative Electroencephalography (QEEG) have been used in numerous research labs around the world to investigate these conditions.

COGNISION™ can provide unique value by allowing complex ERP/QEEG studies to be performed outside the laboratory environment.  This enables ongoing research in the development and refinement of diagnostics and therapeutics to treat these disabilities at an earlier age.

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