Sense Neuro device (Sense Diagnostics)
17 Mar. 2021. A clinical trial is underway testing a device worn like a helmet that scans brain tissue for internal bleeding with radio-frequency waves. The device is made by Sense Neuro Diagnostics in Cincinnati, Ohio to detect bleeding in the brain from a stroke or traumatic brain injury.
Stroke occurs when blood flow to the brain is interrupted, cutting the oxygen needed by brain cells to function. According to Centers for Disease Control and Prevention, the vast majority (87%) of strokes are caused by blood clots, called an ischemic stroke, while many other strokes are hemorrhagic strokes caused by blood vessel leakage, where blood builds up and damages surrounding brain tissue. CDC defines traumatic brain injury as “as a disruption in the normal function of the brain that can be caused by a bump, blow, or jolt to the head, or penetrating head injury.” Effects of TBI include impairments in memory or sensation, and emotional effects, such as personality changes or depression.
The Sense Neuro device is a molded plastic system worn over the head like a helmet or headset, with nine antennae sending out low-power radio frequency signals. The radio waves cross the brain, where they encounter brain cells and tissue. Healthy and damaged brain tissue and blood vessels have characteristic electrical properties that alter the signals and are read by sensors and spectrum analyzer in the device. An individual scan, says the company, takes 2.5 seconds covering 360 data points.
Data from the sensors are then evaluated with a company algorithm to distinguish healthy from damaged tissue, and the nature of the damage: type of injury — stroke or traumatic brain injury — as well as hemorrhage in the brain, and occlusion or blockage of blood vessels. To capture this level of detailed data today, says Sense Neuro, requires several computed tomography or CT scans and repeated assessments by clinicians every few hours.
Enrolling 400 patients with stroke or brain injury
Sense Neuro pilot-tested the device with 17 patients suspected of having a stroke and three healthy participants, with results scheduled for presentation at the Society for Academic Emergency Medicine’s 2021 virtual meeting in May. Among the 17 stroke patients, says the company, the device successfully identified their stroke sub-types with 99 percent accuracy.
The clinical trial is testing the Sense Neuro device with 400 individuals admitted to hospitals with suspected stroke or head trauma, confirmed by a CT scan. Participants are monitored with the Sense Neuro device as well as normal CT scans for 48 hours after admission. Data from the Sense Neuro devices are compared to CT scans for their ability to predict increased bleeding in the brain, of up to three milliliters for spontaneous intracranial hemorrhaging or six milliliters for traumatic intracranial hemorrhaging. The trial has no separate control or comparison participants.
“This rigorously designed trial,” says Sense Neuro’s chief medical officer and scientific founder Opeolu Adeoye in a company statement, “marks important progress in our effort to assist patients and medical personnel by developing technology to monitor intracranial hemorrhage between CT scans and detect changes that may signal expansion of the bleed at the earliest opportunity.” Adeoye recently joined Washington University School of Medicine in St. Louis as the head of its new emergency medicine department.
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