After more than 50 years, the methods for evaluating traumatic brain injuries (TBIs) are being updated.

According to clinicians, the new framework promises more precise diagnoses and treatments, offering more intensive care for some individuals and preventing premature conversations about ending life support for others.

Trauma centers across the nation will soon begin implementing a novel strategy for TBI assessment, which is anticipated to result in more accurate diagnoses, better treatment plans, and improved patient follow-up.

Spearheaded by the National Institutes of Health, the new framework was created by a global coalition of experts and patients from 14 countries. It broadens the scope of assessment beyond immediate clinical symptoms to include biomarkers, CT and MRI scans, and other relevant factors like pre-existing medical conditions and the nature of the trauma.

The framework was published in the May 20 issue of Lancet Neurology.

For over half a century, trauma centers have relied on the Glasgow Coma Scale to evaluate TBI patients, categorizing them into mild, moderate, and severe categories based on their level of consciousness and a limited set of clinical symptoms.

This diagnosis has historically dictated the level of care provided in the emergency department and subsequent treatment. In severe cases, it also influenced recommendations to families regarding the potential withdrawal of life support. Though, medical professionals have long recognized the limitations of these tests in providing a complete picture of the patient’s condition.

“There are patients diagnosed with concussion whose symptoms are dismissed and receive no follow-up because it’s ‘only’ concussion,and they go on to live with debilitating symptoms that destroy their quality of life,” said corresponding author Geoffrey Manley,MD,PhD,professor of neurosurgery at UC San Francisco and a member of the UCSF Weill Institute for Neurosciences. “on the other hand, there are patients that were diagnosed with ‘severe’ TBI, leading full lives, whose families had to consider removing life-sustaining treatment.”

In 2021, TBIs led to approximately 70,000 deaths in the United States and contribute to around half a million permanent disabilities annually. The most frequent causes include motor vehicle accidents, falls, and assaults.

A Tailored Approach to treatment

The new framework, known as CBI-M, is built upon four pillars: clinical evaluation, biomarkers, imaging, and modifiers. These pillars were developed through collaborative efforts involving federal partners, TBI specialists, scientists, and patients.

“We will be much better equipped to match patients to treatments that give them the best chance of survival,recovery,and return to normal life function.”

“The proposed framework marks a major step forward,” said co-senior author Michael McCrea, PhD, professor of neurosurgery and co-director of the Center for Neurotrauma Research at the Medical college of wisconsin in Milwaukee.

The framework was spearheaded by the NIH National Institute of Neurological Disorders and Stroke (NIH-NINDS). Geoffrey Manley, Michael McCrea, and their co-authors are members of the steering committee focused on improving TBI characterization.

The clinical pillar incorporates the Glasgow Coma Scale’s total score as a key element, assessing consciousness and pupil reactivity as indicators of brain function. The framework suggests including the scale’s responses to eye, verbal, and motor commands or stimuli, as well as the presence of amnesia and symptoms like headache, dizziness, and noise sensitivity.

“This pillar should be assessed as first priority in all patients,” said co-senior author Andrew Maas, MD, PhD, emeritus professor of neurosurgery at the Antwerp University Hospital and University of Antwerp, Belgium. “Research has shown that the elements of this pillar are highly predictive of injury severity and patient outcome.”

Biomarkers, imaging, and Modifiers

The second pillar utilizes biomarkers identified through blood tests to provide objective measures of tissue damage, addressing the limitations of clinical assessments that may inadvertently include symptoms unrelated to the TBI.

Notably, low levels of these biomarkers can definitely help determine which patients do not require CT scans, thereby reducing needless radiation exposure and healthcare costs. These patients can then be safely discharged. For those with more severe injuries, CT and MRI imaging, the framework’s third pillar, plays a crucial role in identifying blood clots, bleeding, and lesions that can indicate current and future symptoms.

Biomarkers also help identify suitable candidates for clinical trials aimed at developing new TBI medications, an area that has seen limited progress in the past 30 years. A recently launched trial, set to take place at 18 trauma centers nationwide, may pave the way for new treatment options.

“These biomarkers are crucial in clinical trials,” Manley said. “in the past, we couldn’t tell the difference between a knock on the head and a TBI. Thanks to biomarkers we can make this distinction and ensure that it’s the TBI patient who enrolls in the trial.”

The final pillar, modifiers, evaluates how the injury occurred, such as a fall, blow, or penetrating object. It also considers pre-existing conditions, medications, healthcare access, prior TBIs, substance abuse, and living circumstances.

“This pillar summarizes the factors that research tells us need to be considered when we interpret a patient’s clinical,blood biomarker,and neuroimaging exams,” said co-first author Kristen Dams-O’Connor,PhD,professor of rehabilitation and human performance,and neurology,and director of the Brain Injury Research Center at the Icahn School of Medicine at Mount sinai in New York.

“one example is a patient with underlying cognitive impairment who may require acute monitoring for risk of clinical deterioration, regardless of findings on the initial clinical exam,” she said.

The new framework is currently being implemented on a trial basis at select trauma centers. It will undergo further refinement and validation before full implementation.