Concussion

FDA clears lab blood test for evaluating concussion

Posted by

0


The FDA has cleared Abbott’s laboratory blood test for concussion, making it the first commercially available test of its kind, according to a company press release.

The Alinity i traumatic brain injury test measures two serum biomarkers that are closely associated with brain injury and provides results in 18 minutes. Those with a negative test would be able to avoid a CT scan and may be able to reduce their time waiting at a hospital, the release stated. The test can be used for adult patients within 12 hours of suspected injury.

FDA clears Abbott’s lab-based blood test to evaluate for concussion. Image Adobe Stock
FDA clears Abbott’s lab-based blood test to evaluate for concussion. Image: Adobe Stock

Because misdiagnosis of or undiagnosed TBI can exacerbate its short- and long-term effects, “providing tools that can objectively aid in the evaluation of a TBI or concussion is essential to giving people the answers and treatment they need,” the company said.

“People sometimes minimize a hit to the head, thinking it’s no big deal,” Beth McQuiston, MD, medical director in Abbott’s diagnostics business, said in the release. “Others wonder if a visit to the doctor or emergency room for a possible concussion will provide them with meaningful answers or care. Now that this test will be widely available in labs across the country, medical centers will be able to offer an objective blood test that can aid in concussion assessment. That’s great news for both doctors and people who are trying to find out if they have suffered a traumatic brain injury.”

According to Abbott, the Alinity i TBI test has a 96.7% sensitivity and complements the company’s i-STAT TBI plasma test, a rapid blood test for concussion previously cleared by the FDA in 2021.

Hyperbaric oxygen therapy improves cognitive function in children after concussion

Posted by

0


Results of a randomized, double-blind trial showed that hyperbaric oxygen therapy improved cognitive and behavioral function in children experiencing persistent post-concussion syndrome, as published in Scientific Reports.

Amir Hadanny, MD

Amir Hadanny

Amir Hadanny, MD, chief researcher and head of global clinical operations for Aviv Clinics and certified neurosurgeon, hyperbaric physician and chief medical research officer at the Sagol Center, and colleagues said that persistent post-concussion syndrome (PPCS) is commonly seen in children after traumatic brain injury.

Previous studies have shown adults with PPCS benefit from hyperbaric oxygen therapy (HBOT), prompting researchers to study this treatment in children aged 8 to 15 years who experienced mild to moderate TBI 6 months to 10 years prior that resulted in PPCS.

Fifteen children received HBOT daily for 60 days and 10 received sham treatments, according to the study.

Researchers reported significant increases in general cognitive score, memory, executive function, emotional score, behavioral symptoms, global executive composite score and planning/organizing. These outcomes also correlated with significant improvements in brain MRI microstructural changes.

“The study suggests that HBOT improves both cognitive and behavioral function, PPCS symptoms and quality of life in pediatric PPCS patients at the chronic stage, even years after injury,” the authors concluded.

Healio asked lead study author, Hadanny, to describe how HBOT works and the significance of the study results.

Healio: Please explain how HBOT works.

Hadanny: Before HBOT is considered or included in a patient’s personal treatment plan, each candidate goes through a comprehensive physical, psychological and physiological assessment that includes blood tests, advanced brain imaging (MRI scans and SPECT [single-photon emission computerized tomography] scans), fitness and nutritional analysis.

Once approved for the 12-week program, patients go through 2-hour sessions, 5 days a week, in the comfortable, spacious, multiplace hyperbaric oxygen chambers where they are monitored by medical professionals trained for the specialized hyperbaric environment. Each 2-hour treatment is conducted at a specific therapeutic, yet safe, pressure of 2 atmospheres absolute, equal to the pressure found at 33 feet below sea level.

During the session, the patient breathes 100% oxygen through a personal mask in a unique protocol. The inhaled oxygen fluctuates to harness the body’s regeneration processes. While in the multiplace chamber, patients are seated (as if in a first-class airplane cabin) and participate in a purposeful series of brain exercises on Aviv Clinic’s customized digital tablets.

HBOT helps reverse cognitive and physical injuries by increasing the overall oxygen supply to the body and allowing the brain to recover by triggering neuroplasticity. The method of fluctuating oxygen delivery through Aviv’s treatment program triggers the body’s inherent abilities for regeneration and repair. The body senses the relative change in oxygen and triggers a physiological response; this activates HIF-1 alpha, creating the environment for angiogenesis and stimulation of stem cell proliferation.

Studies have shown that this physiological pathway improves cerebral blood flow, brain metabolism and brain microstructure, leading to improved cognitive and physical functions.

Healio: Does this type of technology need to be FDA-approved? If so, is it?

Hadanny: While HBOT is FDA-approved for several conditions, including burns, carbon monoxide toxicity and decompression sickness, it’s not yet approved for post-concussion syndrome.

Our goal is that through more than 10 years of research and the work of other hyperbaric scientists and researchers, our HBOT protocol will be recognized by the FDA as treatment for conditions like post-concussion syndrome. The same protocols used in HBOT clinical trials are duplicated precisely at Aviv Clinic’s Florida-based facility.

Aviv’s approach to HBOT is far safer than the mild-HBOT or monoplace HBOT chambers currently found in many non-health care facilities, which are not monitored by physicians and can be hazardous if not properly maintained or utilized without scientifically proven protocols. Mild-HBOT “beds” or monoplace chambers are not the same state-of-the-art multiplace chambers that are tested, proven and backed by our double-blinded, sham-controlled clinical studies.

Healio: Please describe how the results of this study are significant to the treatment of post-concussion syndrome in children.

Hadanny: This study is significant because not only is it the first trial that evaluates the treatment of persistent post-concussion syndrome in children, but it also is the first to do that using this unique HBOT protocol. The study provides double-blind, high-quality results suggesting the improvement of cognitive and behavioral function.

This is particularly important as it positively impacts children suffering from persistent post-concussion syndrome even years after the initial brain injury. According to the Brain Injury Association of America, about half a million children suffering from a concussion or traumatic brain injury are discharged from emergency departments in the U.S. each year. While the majority recover in the days and weeks following injury, up to 25% endure symptoms for more than 3 months after their injury and are considered in a persistent post-concussive state, although few are diagnosed accurately.

Children suffering from persistent post-concussive syndrome can experience fatigue, anxiety, irritability, headaches, dizziness and difficulty concentrating or processing words. These symptoms are greatly misunderstood and understudied and often misdiagnosed as other behavioral issues.

Current guidelines for treating concussions span only the first 2 weeks of symptoms. Leaving the brain injury untreated puts the child at a significant disadvantage, directly impacts their development into adulthood and can lead to the need for more mental health care in the future.

The findings of our trial showed a significant increase in cognitive, memory and executive function following the HBOT treatment program. The MRI scans showed improvement in brain structure post-treatment.

Healio: How accessible is such treatment to physicians across the country?

Hadanny: Variations of hyperbaric oxygen chambers are widely available to physicians across the country, but the therapy program and protocols provided at Aviv are exclusive. Aviv Clinics offer HBOT at the core of its brain performance program and involve a specialized, comprehensive approach tailored for each patient, including cognitive and physical training and ongoing medical support from experts tracking progress throughout the program.

Unlike other HBOT monoplace chambers, medical professionals join patients inside the suite during every session. In the unlikely scenario that a problem arises, the medical team is available to administer treatment immediately.

For Former Football Players, Concussion and Hypertension Go Hand in Hand

Posted by

0


Study points to surprising link between head injury and high blood pressure in retired NFL players

Photo of athletes playing football on a field at sunset

The chance that former professional football players will be diagnosed with high blood pressure — a known risk factor for cardiovascular and cognitive dysfunction — rises in step with the number of concussions the athletes sustained during their careers, according to new research by investigators for the Football Players Health Study at Harvard University.

The results held true even after researchers took into account established risk factors known to drive the risk for high blood pressure, or hypertension, including age, body mass index, race, smoking status, and a diagnosis of diabetes.

The results of the study, published Feb. 7 in Circulation, suggest that high blood pressure may be yet another driver of cognitive decline — a condition strongly linked with professional football play in previous studies and believed to stem primarily from repeated head injury. The findings also point to high blood pressure as a modifiable risk factor that could halt or slow both neurologic and cardiovascular damage in former players.

Given that cardiovascular illness remains a top killer in former athletes and in the general population, the researchers said the results should be an impetus for doctors, former players, and their families to consider a history of prior head injury when screening patients for hypertension — even in the absence of other risk factors for this condition.

“If players, families, and physicians are aware of the cardiovascular effects of head injury, we have a better chance of protecting both their cardiovascular health and long-term cognitive health,” said Rachel Grashow, director of epidemiological research initiatives for the Football Players Health Study. Grashow co-led the new study with Aaron Baggish, professor of medicine at the University of Lausanne, senior faculty member at the Football Players Health Study, and former director of Massachusetts General Hospital’s Cardiovascular Performance Program, which provides comprehensive cardiac care to athletes.

The research — based on a survey of more than 4,000 former National Football League players representing the largest study cohort of former professional football players to date — was conducted as part of the ongoing Football Players Health Study at Harvard University, a research program that encompasses a constellation of studies designed to evaluate various aspects of players’ health across their life span.

Grashow explained that most research on cognitive decline in former professional football players has focused on neurodegeneration caused directly by repeated concussions, a prominent aspect of the game. However, the leading cause of death and disability among former football players — and among Americans in general — is cardiovascular disease, a collection of conditions that affect the heart and blood vessels. Hypertension, the most common cause of these conditions, can also gradually damage blood vessels in the brain and, over time, lead to cognitive decline.

Various aspects of professional football, such as purposeful weight gain during play years and deconditioning after career end, are associated with hypertension. However, Grashow, Baggish, and their colleagues wondered whether concussion might also be independently associated with hypertension.

To answer this question, the researchers collected information from 4,168 former NFL players. The team analyzed known risk factors for hypertension in the general population — diabetes, obesity, age, smoking — as well as players’ number of seasons of play, field position, years since play, and the occurrence of 10 common concussion symptoms. These symptoms were used to calculate a concussion symptom score, or CSS.

The analysis showed that as players’ symptom scores rose, so did their likelihood of being diagnosed with hypertension, even after researchers accounted for known hypertension risk factors. Notably, even using the number of occurrences of just one severe symptom of concussion — loss of consciousness — was enough to accurately predict players’ likelihood of developing hypertension.

Grashow said that while it remains unclear exactly how concussion leads to hypertension, one hypothesis is that repeat concussions could cause a chronic inflammation that prompts blood pressure to rise. Uncovering the precise mechanism underlying concussion-related hypertension will be the subject for future research, she added.

Baggish added that unlike many risk factors for cognitive decline, hypertension is potentially controllable with an array of safe and effective therapies, including routine aerobic exercise, dietary modification, and, in some cases, medication.  

“By identifying those at increased risk for hypertension based on their history of head injuries, we could intervene with therapies that not only protect their hearts and blood vessels, but also their brains,” Baggish said.

Authorship, funding, disclosures

Additional authors included Can Ozan Tan, Saef Izzy, Herman Taylor Jr., Marc Weisskopf, Meagan Wasfy, Alicia Whittington, Frank Speizer, and Ross Zafonte.

This work was supported by the Football Players Health Study at Harvard University, which is funded by the National Football League Players Association (NFLPA). The content is solely the responsibility of the authors and does not necessarily represent the official views of Harvard Medical School, Harvard University, and its affiliated academichealthcare centers. The NFLPA had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and the decision to submit the manuscript for publication.

Zafonte reported receiving royalties from Springer/Demos publishing for serving as co-editor of Brain Injury Medicine; serving on the scientific advisory board of Myomo Inc., and onecare.ai Inc; evaluating patients in the Massachusetts General Hospital Brain and Body–TRUST Program, which is funded by the NFL Players Association; and receiving grants from the NIH. Baggish has received funding from the National Institutes of Health National Heart, Lung, and Blood Institute, the National Football Players Association, and the American Heart Association and receives compensation for his role as team cardiologist from the US Olympic Committee/US Olympic Training Centers, US Soccer, US Rowing, the New England Patriots, the Boston Bruins, the New England Revolution, and Harvard University. Taylor reported receiving grants from the NFL Players Association outside the submitted work and grants from the NIH. Weisskopf reported receiving grants from the NFL Players Association and the NIH during the conduct of the study. Grashow, Whittington, and Wasfy received grant funding from the NFL Players Association.

Concussion Symptoms in Children May Have Multiple Underlying Causes

Posted by

0


Summary: Researchers report different types of brain injuries caused by concussions in children may lead to similar symptoms.

Source: McGill University

Different types of brain damage caused by a concussion may lead to similar symptoms in children, according to research led by McGill University. A new way of studying concussions could help develop future treatments.

While most children fully recover after a concussion, some will have lasting symptoms.

The findings published in eLife help explain the complex relationships that exist between symptoms and the damage caused by the injury.

The researchers found that certain combinations of brain damage were associated with specific symptoms such as attention difficulties. Other symptoms, such as sleep problems, occurred in children with multiple types of injuries. For example, damage to areas of the brain that are essential for controlling sleep and wakefulness could cause challenges with sleeping, as could damage to brain regions that control mood.

The brain’s white matter holds clues

To do this, they examined how damage to the brain resulting from concussion affected its structural connection network, known as white matter. They then used statistical modeling techniques to see how these changes related to 19 different symptoms reported by the children or their caregivers.

Analyzing symptoms may advance treatment

“Despite decades of research, no new treatment targets and therapies for concussions have been identified in recent years,” says lead author Guido Guberman, a Vanier Scholar and MDCM Candidate at McGill University.

This shows a sad little girl
While most children fully recover after a concussion, some will have lasting symptoms. Image is in the public domain

“This is likely because damage to the brain caused by concussions, and the symptoms that result from it, can vary widely across individuals. In our study, we wanted to explore the relationships that exist between the symptoms of concussion and the nature of the injury in more detail.”

Guberman and his colleagues analyzed data collected from 306 children, aged 9 to 10 years old, who had previously had a concussion. The children were all participants in the Adolescent Brain Cognitive Development (ABCD) Study.

“The methods used in our study provide a novel way of conceptualizing and studying concussions,” says senior author Maxime Descoteaux, a Professor of Computer Science at Université de Sherbrooke.

“Once our results are validated and better understood, they could be used to explore potential new treatment targets for individual patients. More broadly, it would be interesting to see if our methods could also be used to gather new insights on neurological diseases that likewise cause varied symptoms among patients.”

Concussion may increase risk for mental health issues in youth

Posted by

0


Concussion was linked to increased risk for mental health issues, psychiatric hospitalization and self-harm among youths aged 5 to 18 years, according to results of a population-based retrospective cohort study.

“Few studies have rigorously examined associations between concussion and risk of psychopathology, new onset of psychiatric disorders or long-term [mental health problems],” Andrée-Anne Ledoux, PhD, of the Children’s Hospital of Eastern Ontario Research Institute in Canada, and colleagues wrote.

Girl with concussioon
Source: Adobe Stock.

“The studies that investigated these associations lacked adequate sample size; had heterogeneous population samples, including more severe [traumatic brain injuries]; or had small or no comparison groups.

“Some studies did not adjust for important covariates, such as prior [mental health problem], making it difficult to discern whether concussions precipitated new mental health symptoms or psychiatric disorders.”

Ledoux and colleagues aimed to examine links between concussion and risk for subsequent mental health problems, psychiatric hospitalizations, self-harm or suicides among youth with a concussion or orthopedic injury that occurred between April 1, 2010, and March 31, 2020, in Ontario. Participants did not have a prior mental health visit in the year before the index event, as well as no prior concussion or traumatic brain injuries in the 5 years before the index visit.

Researchers collected data from provincewide health administrative databases and included participants with concussion (n = 152,321; median age, 13 years; 56.7% male) in the exposed group and those with an orthopedic injury (n = 296,482; median age, 13 years; 57.9% male) in the comparison cohort.

Researchers matched these groups in a 1:2 ratio, respectively, on age and sex. Mental health problems, including psychopathologies and psychiatric disorders, identified from health care visits in EDs, hospitalizations or primary care settings, served as the primary outcome. Psychiatric hospitalizations, self-harm health care visits and death by suicide served as secondary outcomes.

Results showed incidence rates of any mental health problem of 11,141 per 100,000 person-years in the exposed group compared with 7,960 per 100,000 person-years in the unexposed group, with a difference of 3,181 (95% CI, 3,073-3,291) per 100,000 person-years.

Among the exposed group, researchers noted an increased risk for developing a mental health issue (adjusted HR = 1.39; 95% CI, 1.37-1.4), self-harm (aHR = 1.49; 95% CI, 1.42-1.56) and psychiatric hospitalization (aHR = 1.47; 95% CI, 1.41-1.53) after a concussion. They observed no statistically significant difference in death by suicide between exposed and unexposed groups (HR = 1.54; 95% CI, 0.9-2.61).

“Our results suggest that clinicians should assess for preexisting and new mental health symptoms throughout concussion recovery; treat mental health conditions or symptoms or refer the patient to a specialist in pediatric mental health; and assess suicidal ideation and self-harm behaviors during evaluation and follow-up visits for concussion,” Ledoux and colleagues wrote.

In a related editorial, Talin Babikian, PhD, ABPP, of the department of psychiatry and biobehavioral sciences at the University of California, Los Angeles, highlighted the takeaways of this study.

“When drawing on the literature on risk and protective factors associated with mental health, the potent common denominators that percolate to the top and have strong relevance in concussion management include a sense of safety and agency and sense of connection and belonging,” Babikian wrote. “Studies, such as the one presented by Ledoux et al, strengthen the association between mental health and concussion — and likely any other major disruption to a young person’s physiology and environment. The good news is that we are acknowledging this risk and paying attention.”

References:

FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults

Posted by

0


The U.S. Food and Drug Administration today permitted marketing of the first blood test to evaluate mild traumatic brain injury (mTBI), commonly referred to as concussion, in adults. The FDA reviewed and authorized for marketing the Banyan Brain Trauma Indicator in fewer than 6 months as part of its Breakthrough Devices Program.

Most patients with a suspected head injury are examined using a neurological scale, called the 15-point Glasgow Coma Scale, followed by a computed tomography or CT scan of the head to detect brain tissue damage, or intracranial lesions, that may require treatment; however, a majority of patients evaluated for mTBI/concussion do not have detectable intracranial lesions after having a CT scan. Availability of a blood test for concussion will help health care professionals determine the need for a CT scan in patients suspected of having mTBI and help prevent unnecessary neuroimaging and associated radiation exposure to patients.

“Helping to deliver innovative testing technologies that minimize health impacts to patients while still providing accurate and reliable results to inform appropriate evaluation and treatment is an FDA priority. Today’s action supports the FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging—an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose,” said FDA Commissioner Scott Gottlieb, M.D. “A blood-testing option for the evaluation of mTBI/concussion not only provides health care professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases. In addition, availability of a blood test for mTBI/concussion will likely reduce the CT scans performed on patients with concussion each year, potentially saving our health care system the cost of often unnecessary neuroimaging tests.”

According to the U.S. Centers for Disease Control and Prevention, in 2013 there were approximately 2.8 million TBI-related emergency department visits, hospitalizations and deaths in the U.S. Of these cases, TBI contributed to the deaths of nearly 50,000 people. TBI is caused by a bump, blow or jolt to the head or a penetrating head injury that disrupts the brain’s normal functioning. Its severity may range from mild to severe, with 75 percent of TBIs that occur each year being assessed as mTBIs or concussions. A majority of patients with concussion symptoms have a negative CT scan. Potential effects of TBI can include impaired thinking or memory, movement, sensation or emotional functioning.

“A blood test to aid in concussion evaluation is an important tool for the American public and for our Service Members abroad who need access to quick and accurate tests,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA’s review team worked closely with the test developer and the U.S. Department of Defense to expedite a blood test for the evaluation of mTBI that can be used both in the continental U.S. as well as foreign U.S. laboratories that service the American military.”

The Brain Trauma Indicator works by measuring levels of proteins, known as UCH-L1 and GFAP, that are released from the brain into blood and measured within 12 hours of head injury. Levels of these blood proteins after mTBI/concussion can help predict which patients may have intracranial lesions visible by CT scan and which won’t. Being able to predict if patients have a low probability of intracranial lesions can help health care professionals in their management of patients and the decision to perform a CT scan. Test results can be available within 3 to 4 hours.

The FDA evaluated data from a multi-center, prospective clinical study of 1,947 individual blood samples from adults with suspected mTBI/concussion and reviewed the product’s performance by comparing mTBI/concussion blood tests results with CT scan results. The Brain Trauma Indicator was able to predict the presence of intracranial lesions on a CT scan 97.5 percent of the time and those who did not have intracranial lesions on a CT scan 99.6 percent of the time. These findings indicate that the test can reliably predict the absence of intracranial lesions and that health care professionals can incorporate this tool into the standard of care for patients to rule out the need for a CT scan in at least one-third of patients who are suspected of having mTBI.

The Brain Trauma Indicator was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.

The FDA is permitting marketing of the Brain Trauma Indicator to Banyan Biomarkers, Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Havana Embassy Staff: ‘Concussion Without Concussion’?

Posted by

0


JAMA study finds real brain injuries, but no hard evidence as to the cause

 

Action Points

  • Persistent cognitive, vestibular, and oculomotor dysfunction, sleep impairment and headaches were observed among US government personnel in Cuba, associated with reports of directional audible and/or sensory phenomena of unclear origin, and without history of head trauma.
  • Note that the initial symptoms appeared to be auditory related and an expert panel concluded that the findings of the triage otolaryngology evaluations most likely were related to neurotrauma from a non-natural source.

Examinations of U.S. Embassy personnel who developed neurological symptoms in 2016 while stationed in Havana, Cuba, indicated that they really did sustain brain injuries, even though none of the individuals experienced head trauma, researchers reported in JAMA.

The embassy employees reported persistent cognitive, vestibular, and oculomotor problems plus sleep impairment and headaches after experiencing an intensely loud, unusual noise or sensation of unknown origin, according to Douglas Smith, MD, and colleagues at the University of Pennsylvania in Philadelphia.

The symptoms resemble mild brain traumatic injury, or concussion, they reported in JAMA. It is unclear if or how the noise is related to the symptoms, and the report shed no light on what else might have caused the symptoms. Some have speculated that the embassy personnel were attacked with an acoustic weapon beamed from outside the embassy.

“These patients are having problems with working memory, sustained attention, and concentration,” co-author Randel Swanson II, DO, PhD, said in an accompanying podcast interview. Like concussion patients, work takes more energy for these people because they lack cognitive reserve. “Something’s happened to the network and it takes them so much more energy so they’re fatigued and by the end of the day, they have massive headaches,” he said.

“This is really concussion without concussion,” Smith added.

In late 2016, U.S. government personnel in Havana reported various neurological symptoms after experiencing strange sounds, described mostly as loud and high pitched, that were associated with a sensation described as pressure-like or vibratory. Initial symptoms appeared to be auditory related and led to a triage program centered on otolaryngology evaluations for embassy community members at the University of Miami. Sixteen individuals who heard the sound presented neurological signs and symptoms that resembled a concussion. Over time, eight additional people reported similar problems.

In July 2017, the U.S. Department of State convened an expert panel which concluded that the triage findings most likely were related to neurotrauma from a non-natural source and recommended further study at the University of Pennsylvania Center for Brain Injury.

Of 24 individuals with suspected exposure to the noise or sensation, 21 completed multidisciplinary evaluation an average of 203 days later. The group included 10 men (average age 39) and 11 women (average age 47).

Nearly all — 20 of 21 people, or 95% — reported immediate neurological symptoms associated with the noise. One individual woke from sleep with acute symptoms including headache, unilateral ear pain, and hearing changes, but did not experience the phenomena.

Twenty embassy personnel reported persistent symptoms — ones that lasted for more than 3 months — that included cognitive (81%), balance (71%), and auditory (68%) problems, sleep impairment (86%), and headaches (76%).

Objective findings included cognitive (76%), vestibular (81%), and oculomotor (71%) abnormalities, the researchers noted. Three individuals experienced moderate to severe sensorineural hearing loss. Fifteen people (71%) required medication for sleep dysfunction and 12 (57%) for headache. Fourteen people stopped working; seven eventually returned to work with restrictions, home exercise programs, and cognitive rehabilitation. All 21 patients had MRI neuroimaging and most had conventional findings within normal limits.

Several important factors need to be considered in this case series, observed Christopher Muth, MD, of Rush University Medical Center in Chicago, and Steven Lewis, MD, of Lehigh Valley Health Network in Allentown, Pennsylvania, in an accompanying editorial.

While the embassy employees were in a common geographic area when their symptoms first appeared, not everyone had the same symptoms. It’s unclear whether individuals who developed symptoms later knew about previous reports, they noted.

“Furthermore, the quantitative results for specific tests (e.g., neuropsychological tests) are not yet available for all affected patients, so independent assessment as to the scope and severity of deficits among all individuals remains challenging,” they wrote.

And the analogy to concussion may be not be quite right because many of the symptoms described also occur in conditions like persistent postural-perceptual dizziness (PPPD), they noted, although “PPPD alone does not appear to explain the entirety of the symptoms reported nor the clustering of individuals affected.”

The symptoms have raised outside concerns about delusional disorders or mass psychogenic illness. But several of the manifestations in this group of patients — including the oculomotor and vestibular testing abnormalities — could not have been manipulated, the researchers maintained.

“Furthermore, mass psychogenic illness is often associated with transient, benign symptoms with rapid onset and recovery often beginning with older individuals,” they wrote. “In contrast, the Havana cohort experienced persisting disability of a significant nature and are broadly distributed in age.”

“Rather than seeking time away from the workplace, the patients were largely determined to continue to work or return to full duty, even when encouraged by healthcare professionals to take sick leave,” they added.

The researchers plan further neuroimaging to evaluate the embassy employees. “Since the clinical features appear so similar to concussion, we will use diffusion tensor imaging and advanced MRI that examines the connectivity of the brain’s network,” Smith told MedPage Today. “This is commonly shown disrupted in concussion. However, if we do find changes, we anticipate that the distribution will be different than in concussion, where some findings are related to head impact.”

In the meantime, the State Department issued a level 3 travel advisory to Cuba, recommending that Americans reconsider trips there due to “health attacks directed at U.S. Embassy Havana employees.”

Blood Test for Concussion OK’d

Posted by

0


Helps inform management, including decision on whether CT scan is indicated

 A blood test aimed at guiding management of patients suspected of having concussion won FDA approval on Wednesday, the agency said.

The test, which measures levels of two proteins in blood, does not by itself provide a firm yes/no as to whether a patient has suffered a brain injury. Rather, it’s an indicator of the likelihood that a CT scan will show intracranial lesions, and hence may be valuable in deciding whether CT scans are indicated.

Currently, it’s routine to order a CT scan for all patients with suspected closed head injuries, the FDA noted, but most scans do not show detectable lesions. The blood test is thus expected to cut down on these unhelpful scans and the associated radiation exposure.

Developed by Banyan Biomarkers, the Brain Trauma Indicator test is a quantitative assay for ubiquitin carboxy-terminal hydrolase L1 and glial fibrillary acidic protein, which are released into the blood following neural injury. The test should be performed within 12 hours of injury; results are available in 3-4 hours, the FDA said.

Trial data involving nearly 2,000 individuals with with suspected concussion or mild traumatic brain injury (mTBI) showed that the test was 97.5% accurate in identifying those with visible lesions on CT scans, and 99.6% accurate in predicting those who did not show such lesions.

“These findings indicate that the test can reliably predict the absence of intracranial lesions and that healthcare professionals can incorporate this tool into the standard of care for patients to rule out the need for a CT scan in at least one-third of patients who are suspected of having mTBI,” the agency said.

New Data Challenge Beliefs About Concussion

Posted by

0


Experts respond to recent study implicating repetitive small blows to the head

New research is challenging the notion that the serious brain damage now seen in professional football players is caused mainly by blows to the head leading to overt concussions.

In a study published in Brain, researchers from Boston University examined the brains of eight teenagers and young adults. Four had “recent sports-related closed-head impact injuries sustained 1 day to 4 months prior to death.” Four had no such history. The researchers found evidence of chronic traumatic encephalopathy (CTE) in the four teenagers who had recent head injury. “These results indicate that closed-head impact injuries, independent of concussive signs, can induce traumatic brain injury as well as early pathologies and functional sequelae associated with chronic traumatic encephalopathy,” the researchers concluded. It may be the best evidence yet that it is the routine head impacts that occur on virtually every play, and not concussions per se, that cause CTE.

This research raises questions about the NFL’S efforts to deal with concussions. It also may influence what advice physicians give to parents who ask about whether their children should play youth football.

Below, the NFL’s chief medical officer, a professor of emergency medicine and neurosurgery, and a pediatrician discuss these questions.

Allen Sills, MD, NFL chief medical officer, past co-director of the Vanderbilt Sports Concussion Center

“Important research advancements have been made over the last several years around traumatic brain injury (TBI) and chronic traumatic encephalopathy (CTE), which have aided awareness and understanding around this important issue. As highlighted in the most recent study, repetitive hits to the head have been consistently implicated as a cause of CTE by this research group. How and why exactly this manifests, who is at risk, and why — these are questions that we as researchers and clinicians are working to answer.

“As the research community continues to explore these critical questions, the NFL has made significant strides to try to better protect our players and reduce contact to the head including implementing data-driven rules; changes intended to eliminate potentially dangerous tactics and reduce the risk of injuries, especially to the head and neck; enforcing limits on contact practice; and mandating ongoing health and safety education for players and training for club and non-affiliated medical personnel.

“For kids, being active, getting outside, playing sports, particularly team sports, is important. There are also concerns about the risks involved in playing sports, including football, which is why it has been encouraging to see similar developments at the youth level such as the certification of over 130,000 youth and high school coaches through USA Football’s Heads Up program; USA Football’s National Practice Guidelines — including limits on full contact; Pop Warner’s initiatives, from no intentional head-to-head contact to requiring players who suffer a suspected head injury to receive medical clearance from a concussion specialist before returning to play; and 50 states have a Return to Play law, which can help reduce the rates of recurrent concussions. We hope that all youth sports will continue to take measures to reduce head contact through similar rules changes, education, and improved protective equipment.”

Jeffrey Bazarian, MD, MPH, professor of emergency medicine, physical medicine and rehabilitation, neurology, neurosurgery, and public health science, University of Rochester

The National Football League has done an admirable job of supporting research to better identify, prevent and treat sport-related concussions. But more recent research data suggest that the real threat to the long-term neurologic health of contact athletes like football players is not concussion, but the repetitive head hits that do not result in acute symptoms of concussion. These head hits are experienced by all players during nearly every football practice and game. They have been associated with acute changes in brain function and structure, and with short-term cognitive deficits. They have also been reported to have clinically-relevant, long-term adverse consequences on the brain. Repetitive head hits experienced by football players should be reconceived as an occupational exposure that can be assessed, controlled, and managed. The NFL is uniquely positioned to foster research to identify, prevent, and treat the neurologic consequences of these hits, and would be wise to turn its attention in the direction of repetitive head hits as soon as possible.

Steven Hicks, MD, assistant professor of pediatrics, Penn State Health and Milton S. Hershey Medical Center

As a general pediatrician, I believe we can do several things to make sports like football (with high concussion risk) safer for our children: 1) be open to rule changes that may make the game safer by minimizing concussive events; 2) ensure that medical personnel are on the sideline at games, to accurately assess potential concussions and ensure that concussion guidelines are followed; 3) teach children to tackle safely and reduce full-contact scenarios in daily practice; and 4) support research that improves our understanding, prevention, and treatment of concussions. Making decisions about youth football participation will require us to balance risks and benefits. By minimizing concussion risks on the field we can hopefully find ways to allow children to continue to benefit from participation in this team sport.

Brain changes seen in youth football players without concussion.

Posted by

0


Researchers have found measurable brain changes in children after a single season of playing youth football, even without a concussion diagnosis, according to a new study.
MR images of left inferior fronto-occipital fasciculus (top) before and (middle) after the playing season, and (bottom) the overlay. In the overlay (bottom), the red region is after the season and the blue region is before the season.

Researchers have found measurable brain changes in children after a single season of playing youth football, even without a concussion diagnosis, according to a new study published online in the journal Radiology.

According to USA Football, there are approximately 3 million young athletes participating in organized tackle football across the country. Numerous reports have emerged in recent years about the possible risks of brain injury while playing youth sports and the effects it may have on developing brains. However, most of the research has looked at changes in the brain as a result of concussion.

“Most investigators believe that concussions are bad for the brain, but what about the hundreds of head impacts during a season of football that don’t lead to a clinically diagnosed concussion? We wanted to see if cumulative sub-concussive head impacts have any effects on the developing brain,” said the study’s lead author, Christopher T. Whitlow, M.D., Ph.D., M.H.A., associate professor and chief of neuroradiology at Wake Forest School of Medicine in Winston-Salem, N.C.

The research team studied 25 male youth football players between the ages of 8 and 13. Head impact data were recorded using the Head Impact Telemetry System (HITs), which has been used in other studies of high school and collegiate football to assess the frequency and severity of helmet impacts. In this study, HITs data were analyzed to determine the risk weighted cumulative exposure associated with a single season of play.

The study participants underwent pre- and post-season evaluation with multimodal neuroimaging, including diffusion tensor imaging (DTI) of the brain. DTI is an advanced MRI technique, which identifies microstructural changes in the brain’s white matter. In addition, all games and practices were video recorded and reviewed to confirm the accuracy of the impacts.

The brain’s white matter is composed of millions of nerve fibers called axons that act like communication cables connecting various regions of the brain. Diffusion tensor imaging produces a measurement, called fractional anisotropy (FA), of the movement of water molecules in the brain and along axons. In healthy white matter, the direction of water movement is fairly uniform and measures high in FA. When water movement is more random, FA values decrease, which has been associated with brain abnormalities in some studies.

The results showed a significant relationship between head impacts and decreased FA in specific white matter tracts and tract terminals, where white and gray matters meet.

“We found that these young players who experienced more cumulative head impact exposure had more changes in brain white matter, specifically decreased FA, in specific parts of the brain,” Dr. Whitlow said. “These decreases in FA caught our attention, because similar changes in FA have been reported in the setting of mild TBI.”

It is important to note that none of the players had any signs or symptoms of concussion.

“We do not know if there are important functional changes related to these findings, or if these effects will be associated with any negative long-term outcomes,” Dr. Whitlow said. “Football is a physical sport, and players may have many physical changes after a season of play that completely resolve. These changes in the brain may also simply resolve with little consequence. However, more research is needed to understand the meaning of these changes to the long-term health of our youngest athletes.”