Medical Devices: Evidence and Research (Dec 2020)
Physiological Vibration Acceleration (Phybrata) Sensor Assessment of Multi-System Physiological Impairments and Sensory Reweighting Following Concussion
Abstract
John D Ralston,1 Ashutosh Raina,2,3 Brian W Benson,4,5 Ryan M Peters,6,7 Joshua M Roper,1 Andreas B Ralston1 1PROTXX, Inc., Menlo Park, CA 94025, USA; 2Center of Excellence for Pediatric Neurology, Rocklin, CA 95765, USA; 3Concussion Medical Clinic, Rocklin, CA 95765, USA; 4Benson Concussion Institute, Calgary, Alberta T3B 6B7, Canada; 5Canadian Sport Institute Calgary, Calgary, Alberta T3B 5R5, Canada; 6Faculty of Kinesiology, University of Calgary, Calgary, Alberta T2N 1N4, Canada; 7Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta T2N 1N4, CanadaCorrespondence: John D Ralston Tel +1 6502158418Email [email protected]: To assess the utility of a head-mounted wearable inertial motion unit (IMU)-based physiological vibration acceleration (“phybrata”) sensor to support the clinical diagnosis of concussion, classify and quantify specific concussion-induced physiological system impairments and sensory reweighting, and track individual patient recovery trajectories.Methods: Data were analyzed from 175 patients over a 12-month period at three clinical sites. Comprehensive clinical concussion assessments were first completed for all patients, followed by testing with the phybrata sensor. Phybrata time series data and spatial scatter plots, eyes open (Eo) and eyes closed (Ec) phybrata powers, average power (Eo+Ec)/2, Ec/Eo phybrata power ratio, time-resolved phybrata spectral density (TRPSD) distributions, and receiver operating characteristic (ROC) curves are compared for individuals with no objective impairments and those clinically diagnosed with concussions and accompanying vestibular impairment, other neurological impairment, or both vestibular and neurological impairments. Finally, pre- and post-injury phybrata case report results are presented for a participant who was diagnosed with a concussion and subsequently monitored during treatment, rehabilitation, and return-to-activity clearance.Results: Phybrata data demonstrate distinct features and patterns for individuals with no discernable clinical impairments, diagnosed vestibular pathology, and diagnosed neurological pathology. ROC curves indicate that the average power (Eo+Ec)/2 may be utilized to support clinical diagnosis of concussion, while Eo and Ec/Eo may be utilized as independent measures to confirm accompanying neurological and vestibular impairments, respectively. All 3 measures demonstrate area under the curve (AUC), sensitivity, and specificity above 90% for their respective diagnoses. Phybrata spectral analyses demonstrate utility for quantifying the severity of concussion-induced physiological impairments, sensory reweighting, and subsequent monitoring of improvements throughout treatment and rehabilitation.Conclusion: Phybrata testing assists with objective concussion diagnosis and provides an important adjunct to standard concussion assessment tools by objectively ascertaining neurological and vestibular impairments, guiding targeted rehabilitation strategies, monitoring recovery, and assisting with return-to-sport/work/learn decision-making.Keywords: wearable sensor, physiological vibration acceleration, concussion, multi-system impairment, sensory reweighting
