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Can a blood test be

developed to assess mTBI?

 

 

Brain injury is unpredictable in its consequences, affecting who we are, the way we think, act, and feel1. Identifying a brain injury early-on can impact treatment therapy and can improve patient outcomes. A partnership between Philips and Banyan Biomarkers of San Diego, is working to address this challenge.

 

Although active duty soldiers may sustain a traumatic brain injury (TBI), many others are afflicted while in garrison, or after retiring from the service. Cases of severe TBI are obvious and physically debilitating. However, mild TBI, or ‘mTBI’ (aka, concussion) can be more difficult to diagnose and its symptoms not immediately evident.

 

Those suffering from ‘post-concussion syndrome’ often struggle. Persistent symptoms adversely affect quality of life, spark behavioral changes and delay the patient’s ability to return to work/duty.

 

The question often asked is, how can we assess mTBI in its earliest stages to treat it more effectively? A simple blood test may be the answer.

VA Brain Trust

 

The U.S. Department of Veterans Affairs is excited to announce an inaugural public-private partnership brain health event that focuses on mild TBI and PTSD. The event is designed to promote forward-thinking dialogue among industry, national sports organizations, the DoD and other Federal Agencies, innovators, scientists, clinicians - and the Veterans and caregivers they serve.

 

VA Brain Trust event

My VA

 

At the VA, the ‘MyVA’ initiative is transforming the way Veterans receive service by putting the needs, expectations and interests of Veterans and their families first –giving them a choice of how, when, and where they find care. As part of this fundamental shift in culture, the VA is working to facilitate new solutions to manage the effects of PTSD and mTBI.

What is mild Traumatic Brain Injury (mTBI)?

 

According to the US CDC, there are approximately 2.5 million Emergency Department visits, hospitalizations, or deaths associated with traumatic brain injury in the US annually2. Causes of TBI can be as varied as the people it affects including damage by explosive devices, falls, and motor vehicle accidents.

 

Traumatic brain injury is defined as an alteration in brain function, or other evidence of brain pathology, caused by an external force3. It is classified as mild (more then 80% of TBI at the ED), moderate, or severe. The phrase ‘mild traumatic brain injury’ is a bit misleading as the word “mild” is used in reference to the severity of the initial physical trauma that caused the injury. It does not indicate the severity of the consequences of that injury4.

 

Symptoms of mTBI may be limited at the time of injury. Post concussion syndrome may appear hours, days, and even weeks after the primary event. When they do manifest, they are quite similar to symptoms of PTSD.

Know the signs…

 

15% of people with mTBI have symptoms that last one year or more5.

 

mTBI symptoms can include:

 

  • Fatigue
  • Headaches
  • Visual disturbances
  • Memory loss
  • Poor attention/concentration
  • Sleep disturbances
  • Dizziness/loss of balance
  • Irritability-emotional disturbances
  • Feelings of depression
  • Seizures
  • Nausea
  • Loss of smell
  • Sensitivity to light and sounds
  • Mood changes
  • Getting lost or confused
  • Slowness in thinking

mTBI: tough to diagnose and risk stratify

 

Physicians struggle to provide a quick and proper diagnosis of mTBI. Often the person looks, moves, and acts normally. While 90% of patients with minor head injury have no CT scan abnormalities, many go on to exhibit long-term neuropsychological dysfunction. Failure to make a correct diagnosis and timely selection of the appropriate treatment can have serious implications.

 

Early identification of patients at risk for long-term neuropsychological dysfunction could greatly improve opportunities for effective, targeted therapies. Yet, currently there is no simple point-of-care test available to physicians in the emergency room or hospital that can accomplish this.

 

A blood test for early diagnosis of mTBI?

 

The growing number of TBI patients in the DoD/VA healthcare system has had a detrimental impact on patient volume. To better manage this volume Philips and Banyan Biomarkers are collaborating with the Department of Defense todevelop a point-of-care blood test to quickly evaluate traumatic brain injury.

 

Dr. Joseph Frassica, Chief Science Officer for Philips Research North America sets the premise, “We asked ourselves, is there a biomarker of some sort – whether it’s an imaging biomarker, a chemical biomarker, or some physiological biomarker – that we can use to predict which patients with mTBI will go on to have post injury psychiatric problems?”

 

In answer, Banyan has discovered two protein biomarkers that rapidly appear in the blood of patients soon after injury, and they have developed assays to quantify these proteins. Detecting these biomarkers may provide early indications of brain trauma in patients and lead to improved treatment decisions.

 

Hope for millions

 

Philips has started the development of a Point of Care TBI blood test that will be performed on the Philips Minicare I-20 system and will utilize the Banyan TBI Panel.

 

The system consists of:

  • Handheld analyzer
  • Dedicated software
  • Single use disposable cartridge containing the application specific test

 

The intent is that the test will be carried out at bedside from a drop of blood, and provide results in minutes.

Scenario

 

Point-Of-Care Test (POCT) for patients with head injuries will help clinicians reach decisions.

Neurological examination performed

 

Bedside neurological examination performed

TBI Minicare POCT presents results

 

Minicare TBI POCT presents positive or negative results

Positive results followed up by MRI

 

Positive results followed up by neuroimaging

Banyan Biomarkers, with support from the U.S. Department of Defense has successfully conducted several human feasibility studies and completed enrollment of 2000 patients for an international pivotal study. "A rapid and objective point-of-care test to evaluate traumatic brain injury will help millions of patients throughout the world," stated Jackson Streeter, MD, Chief Medical Officer of Banyan Biomarkers.

 

Another recent independent study published online by JAMA Neurology also favorably supports the ability of biomarkers to help evaluate mTBI.

 

This quick, accurate blood test may do more than help change the course of care. It may change the course of someone’s life.

Device biomarker

An open platform strategy

 

“The collaboration with Banyan Biomarkers is another example of Philips open platform strategy to allow other companies to use our Minicare I-20 system. We are open to novel TBI biomarkers which aim to improve the rule-in/rule out for mild TBI.”

 

– Marcel van Kasteel, CEO of Philips Handheld Diagnostics.

1 Living with Brain Injury, Brain Injury Association of America, website, accessed 3/29/16, http://www.biausa.org/livingwith-brain-injury.htm

 

2 Injury Prevention & Control: Traumatic Brain Injury & Concussion, Centers for Disease Control and Prevention, website, accessed, 3/29/16, http://www.cdc.gov/traumaticbraininjury/get_the_facts.html

 

3 Menon, David K., et. al., Position Statement: Definition of Traumatic Brain Injury, Archives of Physical Medicine and Rehabilitation, November 2010, Volume 91, Issue 11, Pages 1637-1640, website, accessed 3/29/16, http://www.archivespmr.org/article/S0003-9993%2810%2900650-7/abstract

 

4 Mild Brain Injury and Concussion, Brain Injury Association of America, website, accessed 3/29/16, http://www.biausa.org/mild-brain-injury.htm

 

5 TraumaticBrainInjury.com, http://www.traumaticbraininjury.com/symptoms-of-tbi/mild-tbi-symptoms/

A noninvasive intracranial blood pressure test?

 

In a parallel initiative, Philips is teaming up with researchers in MIT’s Institute for Medical Engineering and Science (IMES) and surgeons at Boston Medical Center’s Department of Neurosurgery to test and refine a noninvasive way to measure intracranial pressure (ICP) using ultrasound technology.

 

“Today,” says Dr. Frassica, “for patients that have head/brain injuries, one of the things we need to do is follow the pressure inside the skull. In cases of severe brain injuries we put catheters through the skull to continuously measure the pressure and then drain fluids or administer medication to decrease as required. However, we hesitate to insert catheters into patients who are on the borderline between moderate and severe, because it is an invasive procedure that carries significant risk. In those patients we wonder if noninvasively measuring the ICP would alter our treatment. I suspect it certainly would.”

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