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2.5 MM


Number of Emergency Room Visits in the U.S. per year



Number of the 2.5 MM people who are



FDA Approved drugs to treat Traumatic Brain Injury

A traumatic brain injury (TBI) can be caused by a forceful bump, blow, or jolt to the head or body, or from an object that pierces the skull and enters the brain. Not all blows or jolts to the head result in a TBI. Some types of TBI can cause temporary or short-term problems with normal brain function, including problems with how the person thinks, understands, moves, communicates, and acts. More serious TBI can lead to severe and permanent disability, and even death.

Some injuries are considered primary, meaning the damage is immediate. Other outcomes of TBI can be secondary, meaning they can occur gradually over the course of hours, days, or appear weeks later. These secondary brain injuries are the result of reactive processes that occur after the initial head trauma.




There are two broad types of head injuries: Penetrating and non-penetrating.

  • Penetrating TBI (also known as open TBI) happens when an object pierces the skull (e.g., a bullet, shrapnel, bone fragment, or by a weapon such as hammer or knife) and enters the brain tissue. Penetrating TBI typically damages only part of the brain.

  • Non-penetrating TBI (also known as closed head injury or blunt TBI) is caused by an external force strong enough to move the brain within the skull. Causes include falls, motor vehicle crashes, sports injuries, blast injury, or being struck by an object.


Some events can cause both penetrating and non- penetrating TBI in the same person.

The CDC estimates there are about 2.8 million TBIs each year – mostly from falls and automobile accidents – and about 60% of them completely recover within a year.  The remaining 40% – more than one million people per year – suffer ongoing cognition, motor, memory, mood and/or personality deficits that define this condition.  Moreover, the CDC estimates, the economic cost of TBI in the U.S. is at a staggering $4.2 Trillion dollars annually.

To put TBI into perspective, the one million new cases of chronic TBI are more than all the newly diagnosed cases of breast, prostate, colon, and lung cancer combined. The company estimates that upwards of ten million people in the U.S. may suffer from chronic TBI. Although sports injuries are usually considered the leading cause of concussions and brain injury, the reality is that the leading causes of TBI related hospitalizations were falls and motor vehicle crashes with the leading causes of TBI related death being suicide and falls.

TBI is an injury caused by an external force that disrupts normal brain function, such as a jolt, bump, blow to the head or a penetrating head injury.  The primary injury can be described as the mechanical damage occurring at the time of trauma to the neurons, axons, glia and blood vessels through shearing, tearing and stretching.  Such events pave the way for secondary pathophysiological cascades that include biochemical, metabolic and physiological changes such as ionic imbalance, release of excitatory neurotransmitters, mitochondrial dysfunction and activation of inflammatory and immune processes.  Survivors may experience a substantial burden of physical, psychiatric, emotional, and cognitive disabilities, which disrupt the lives of individuals and their families, and pose huge costs to society. 

Post-concussive symptoms that persist beyond 3 months (late persistent symptoms) may be grouped into the following domains: 

  • Neurologic -   headaches, neuro changes, eye tracking, auditory processing, etc.

  • Cognitive - memory, attention, exec function, speed of processing, etc.

  • Affect - depression, anxiety, PTSD, PTS symptoms, mood, change in personality

  • Somatic - pain out of proportion to expectation, preoccupation with pain

  • Cardiac – often neglected, but brain injured patients have increased cardiac death; may be due to autonomic dysfunction

  • Neuro endocrine - changes in neuro endocrine axis with multiple outcome effects.


These symptoms vary from subject to subject and may be related to pre-TBI clinical states, the locations of the brain injury and neuropathological sequences caused by the TBI.


Management of post-concussion syndrome (PCS) typically involves treatments addressing specific symptoms; for example, patients can take non-opioid analgesics for headaches and medicine to relieve depression or insomnia.  Although no pharmacological treatments exist for PCS, doctors may prescribe medications used for symptoms that also occur in other conditions, for example, anti-depressants for the depression that frequently follows TBI.  Psychological treatment, to which about 40% of PCS patients are referred for consultation, has been shown to reduce symptoms.  Ongoing disabilities may be treated with rehabilitation therapy to improve function at work, social or other contexts.  Therapy aims to aid in the gradual return to work and other pre-injury activities, as symptoms permit.  

There are currently no approved pharmacological agents for treatment of the arrays of persistent symptoms of post-concussive disorders. 

TBI can have long-term consequences on cognitive function, behavior, and quality of life


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