A new study determined more than 30 percent of unnecessary head CT scans could be avoided with the use of the FDA-cleared BrainScope One medical device.

The study is titled, Reduction in unnecessary CT scans head-injury in the emergency department using an FDA cleared device.

“Greater than 80 percent of patients who arrive at the emergency department with a mild traumatic brain injury (mTBI) will be scheduled for a CT scan to rule out a structural injury. On average, mTBI patients who receive a CT scan spend approximately 6.6 hours in the ED, including a 2.5 hour waiting period for the scan to be performed and assessed by a radiologist,” BrainScope CEO Michael Singer told HCB News. “Ninety-one percent of these scans are negative, exposing the patient to unnecessary radiation. Additionally, a CT scan does not indicate the presence or severity of concussion, resulting in many concussed patients being discharged with little or no follow-up.”

The multi-modal, comprehensive, handheld system utilizes AI to perform objective and quick assessments and triages of head-injured patients at the point of care, deeming them either likely CT positive (structural brain injury) or likely CT negative (no structural brain injury). It is equipped to evaluate the full spectrum of brain injury for those with mTBI, from functional abnormalities like concussions to structural injuries such as brain bleeds.

Researchers evaluated 91 patients admitted to the Jewish Hospital Washington University Medical Center ER, who each sustained closed head injuries within three days prior to their admission, with the mean time since the event being 10.8 hours. Eighty-two percent of injuries were caused either by motor vehicle collisions or falls. Patients were 18-76, and nearly all scored a 15 on the Glasgow Coma Scale. The exception was one patient with a score of 14.

All were referred for a CT scan, which was read by a site neuroradiologist and evaluated for related traumatic brain injury. They then underwent a 5-10 minute BrainScope EEG-based structural injury classifier (SIC) evaluation using a proprietary disposable EEG headset, with the exam administered by physician assistants, nurses or technicians.

Along with avoiding unnecessary imaging and associated radiation exposure, the device reduced throughput times and was able to better triage patients who required a CT scan. It also demonstrated a rate of 100 percent sensitivity, with the decrease in unnecessary CT scans and associated radiation resulting in no false negative cases. In addition, the findings confirm the overall CT referral rate reduction results of a retrospective study published in 2017 of the data collected in the BrainScope FDA validation study.

The use of BrainScope enables clinicians to determine if a brain bleed is likely, so they can decide if a patient needs to be expedited. It also provides an understanding of the potential presence of a functional injury so that appropriate post-concussion care is discussed before a patient is discharged. Due to its EEG capabilities, BrainScope is capable of detecting brain injuries that may not be visible on CT scans, opening up its potential use in cases that require MR exams.

“In BrainScope’s clinical FDA validation study, a negative predictive value of 98 percent was reported — meaning that if you were found to be BrainScope negative there was a very high likelihood that the patient did not have a brain injury visible on the CT scan,” said Singer. “Therefore, BrainScope One may be used in the future to help identify those patients who may need advanced neuroimaging (for example MR), who might be found to be CT-, but who have suffered a brain injury. This would help better, cost-effectively determine who needs imaging and what type of imaging, which could help ensure clinically appropriate scanning decisions.”

BrainScope is currently used in a range of healthcare settings, including urgent care and occupational health clinics, concussion clinics, hospital emergency rooms, the U.S. military, university sports and student health centers, professional sports, and pharmaceutical clinical trials.

New future clinical indications for the EEG-based platform are currently under consideration.

The findings were published in The American Journal of Emergency Medicine.