A handheld electroencephalography (EEG) device can quickly and effectively determine whether a patient has a brain bleed after sustaining a head injury, new research suggests.
Last year, the US Food and Drug Administration (FDA) cleared the Ahead 300 (BrainScope Company Inc) for the assessment of traumatic brain injury (TBI). The mobile device combines EEG, proprietary algorithms, machine learning, and smartphone technology.
The new multisite study, which included 720 adult patients who came to emergency departments (EDs) with a closed head injury, showed 92% to 97% sensitivity for a TBI with the presence of intracranial blood and 93% to 98% sensitivity for predicting traumatic hematomas.
“We were surprised that the predictability improved substantially between our prior study, which had a sensitivity of around 88% to 90%, and this one,” lead author, Daniel Hanley, MD, director of the Brain Injury Outcomes Program at Johns Hopkins University School of Medicine, Baltimore, Maryland, told Medscape Medical News.
Dr Daniel Hanley
“And we were pleased to see that the changes that were made in the instrument really improved it,” added Dr Hanley. “I think the take-away from this study is that quantitative tools to help us evaluate mild traumatic brain injury are now a reality.”
The findings were published online in Academic Emergency Medicine.
“Opens Up Possibilities”
The investigators note that approximately 2.5 million patients come to EDs in the United States with suspected head injuries each year. While most undergo computed tomography (CT), more than 90% of these scans do not show any structural injury to the brain, they write.
“Before our study, there was no objective, quantitative measures of mild head injury other than imaging,” said Dr Hanley in a release. But the new device “opens up the possibility of diagnosing head injury in a very early and precise way.”
In the current study, 720 patients aged 18 to 85 years (60% men) presented within 72 hours of sustaining a head injury to 11 EDs between February and December 2015. All had scores of 12 to 15 on the Glasgow Coma Scale (GCS).
After undergoing CT ordered by the ED physician, patients reclined for 5 to 10 minutes while a disposable headset recorded EEG information and fed it to the Ahead 300 device.
Additional information entered into the device included age and other demographic data, GCS score, and whether a loss of consciousness had occurred.
In the study population, 156 had a brain injury visible on CT scan (CT+), while the remaining 564 were classified as CT–. In addition, 73 of the CT+ patients had measurable blood in the brain that was greater than 1 mL.
The handheld device had an overall sensitivity to likely CT+ or CT– of 92.3%. When a three-tier classification (of likely CT+, likely CT–, or equivocal) was used, this rate went up to 97.4%.
The two-tier/binary specificity rate was 51.6%, but the three-tier rate was 38.7%. Interestingly, specificity went up to its highest point (76.7%) in the patients with little or no functional impairment.
“Specificity was significantly higher than standard CT decision rules,” based on the Canadian Head CT and New Orleans Criteria, write the investigators.
The binary negative predictive value for the device was 96%, with a three-tier rate of 98.2%.
With use of the two- and three-tier classifications, the sensitivity was 93.2% and 98.6%, respectively, for traumatic hematomas of at least 1 mL of blood.
Finally, five serious adverse events (AEs) occurred in the study, but all five, which were hospital readmissions, were deemed not related to the device. Although not serious, one treatment-related AE was reported: a burning sensation on the forehead.
Useful Biomarker?
The investigators note that “real world sensitivity in epidemiologic data sets” will be needed to determine the exact sensitivity levels for CT+ classification, “which would best inform utilization in practice.”
But for now, the study shows that an electrical activity–based algorithm could potentially be a useful biomarker of TBI and acute traumatic bleeding, they write.
“This technology is not meant to replace the CT scan in patients with mild head injury, but it provides the clinician with additional information to facilitate routine clinical decision-making,” said Dr Hanley.
He added that the device could also be useful in deciding whether someone with a sports- or battle-related head injury needs to be quickly transported to the hospital.
“Alternatively, if there is an accident with many people injured, medical personnel could use the device to triage which patients would need to have CT scans and who should go first.”
Although this study didn’t look at younger patients, Dr Hanley reported that there are currently plans to assess adolescents with mild TBI.
“There are also plans to study further the group of patients we identified here that don’t have bleeding in the brain but do have an abnormal EEG, and their degree of abnormality correlates with the severity of their concussion symptoms,” he said.
“It looks like this machine is capable of objectively sorting some concussed patients with those who are unlikely to have concussion symptoms.”
The handheld device is currently available “to a limited audience through a centers of excellence program,” according to the release.
The study was funded in part by a research contract from the US Army. The study authors have disclosed no relevant financial relationships.
Acad Emerg Med. Published online March 31, 2017. Abstract
Follow Deborah Brauser on Twitter: @MedscapeDeb. For more Medscape Neurology news, join us on Facebook and Twitter.
Tidak ada komentar:
Posting Komentar