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EP-4739204-A2 - A METHOD OF DETERMINING RECOVERY FROM CONCUSSION

EP4739204A2EP 4739204 A2EP4739204 A2EP 4739204A2EP-4739204-A2

Abstract

A system and method for detecting or verifying recovery from concussion includes a headset or head-attachable device placed against the head of a patient who has exhibited concussion. In the device is an accelerometer for detecting and measuring natural motions of the head due to blood flow in the brain. After a prescribed number of days post-concussion, when the patient returns to physical activity, the accelerometer data from natural motions are analyzed to determine whether concussion persists. Preferably a gross movement accelerometer is also included in the head-attachable device, to record gross movements of the head, so as to correlate any increase in concussion-indicating data with the return to physical activity.

Inventors

  • LOVOI, PAUL, A.
  • SMITH, WADE

Assignees

  • The Regents of the University of California

Dates

Publication Date
20260513
Application Date
20240628

Claims (13)

  1. 1. A method for detecting status of recovery from brain concussion in a human patient, by detection and measuring of natural motions of the patient’s head due to blood flow in the brain and resultant movement of tissue in the brain, comprising: providing a head-attachable sensor device including a first accelerometer sensor, sensitive to said natural motions of the head, providing a second accelerometer sensor securable to the patient, the second accelerometer being sensitive to larger movements related to jarring, impacts or sudden movements of the patient, both the sensors being connected to a computer which receives and records accelerometer signals from the first and second sensors, with a patient having a confirmed concussion, immediately, or after a selected number of days following onset of concussion, attaching the head-attachable sensor device on the patient’s head such that the first accelerometer sensor contacts the head so as to record frequency of natural motions of the skull on at least one axis at the location of the first sensor, in a frequency range up to about 25 Hz, attaching the second accelerometer sensor to the patient such that the second sensor detects and records larger accelerations of the patient from jarring, impacts or sudden movements, after the patient engages in physical activity wearing the first and second accelerometer sensors, receiving and recording with the computer, signal data from the first and second accelerometer sensors, representing said natural motions in the head as well as motions from sudden movements, jarring or impacts, with the computer, comparing said signal data with data corresponding to nonconcussion, to determine occurrence of and magnitude of any increase in frequency content of skull motion with the first accelerometer sensor, in frequency ranges above about the fourth harmonic of the patient’s heartbeat, indicative of non-recovery from concussion, while verifying the patient’s physical activity prior to or concurrent with the time of the data with the second accelerometer sensor as a cause of any detected increase in frequency content, and restricting the patient from said physical activity if the comparison by the processor is indicative of non-recovery from concussion.
  2. 2. The method of claim 1, further including, in the event non-recovery from concussion is indicated, continuing to monitor signal data from the first and second sensors and, when the patient again returns to physical activity, determining whether concussion is still indicated, and repeating this procedure until physical activity ceases to be indicative of non-recovery of concussion.
  3. 3. The method of claim 1, wherein the second accelerometer sensor is contained in the head-attachable sensor device.
  4. 4. A method for detecting status of recovery from brain concussion in a human patient, by detection and measuring of natural motions of the patient’s head due to blood flow in the brain and resultant movement of tissue in the brain, comprising: including an accelerometer sensor sensitive to said natural motions of the head, the sensor being connected to a computer which receives and records accelerometer signals from the sensor, with a patient having confirmed concussion, after a selected number of days following onset of concussion, attaching the sensor device on the patient’s head such that the sensor contacts the head so as to record frequency of natural motions of the skull on at least one axis at the location of the first sensor, in a frequency range up to about 25 Hz, after the patient engages in a physical activity wearing the head-attachable sensor device, receiving and recording with the computer, signal data from the accelerometer sensor, representing said natural motions in the head, with the computer, comparing said signal data with data corresponding to nonconcussion, to determine occurrence of and magnitude of any increase in frequency content of skull motion with the accelerometer sensor, in frequency ranges above about the fourth harmonic of the patient’s heartbeat, indicative of non-recovery from concussion, while verifying the patient’s physical activity prior to the time of the data as a cause of any detected increase in frequency content, and restricting the patient from said physical activity if the comparison by the processor is indicative of non-recovery from concussion.
  5. 5. The method of claim 4, further including, in the event non-recovery from concussion is indicated, continuing to monitor signal data from the accelerometer sensor and, when the patient again returns to physical activity, determining whether concussion is still indicated, and repeating this procedure until physical activity ceases to be indicative of nonrecovery of concussion.
  6. 6. An apparatus for detecting status of recovery from brain concussion in a human patient, by detection and measuring of natural HeadPulse motions of the patient’s head due to blood flow in the brain and resultant movement of tissue in the brain, comprising: a head-attachable device including a first accelerometer sensor, sensitive to said HeadPulse forces of the head, a second accelerometer sensor device attachable to the patient and sensitive to larger movements relating to jarring or impacts during physical activity, the head-attachable device with the first accelerometer sensor, and the second accelerometer sensor device including electronics connected to the sensors for receiving acceleration signals and generating digital acceleration signal data, and a processor connected to the electronics, with comparison means for comparing said signal data with data corresponding to non-concussion, to determine occurrence of and magnitude of any increase in frequency content of HeadPulse motion with the first sensor, in frequency ranges above about the fourth harmonic of the patient’s heartbeat, indicative of non-recovery from concussion, and for correlating any such increase in frequency content with any larger movements due to jarring or impacts to the patient, whereby if non-recovery is indicated in the patient at a time weeks after confirmation of concussion, the patient’s physical activity prior to the time of the signal data can be verified with the second accelerometer device sensor as a cause of the detected increase in frequency content.
  7. 7. The apparatus of claim 6, wherein the second accelerometer sensor device is included in the head-attachable device so as to detect jarring movements of the head.
  8. 8. The apparatus of claim 7, wherein the processor is located remotely from the head- attachable device, connected thereto wirelessly.
  9. 9. The apparatus of claim 6, wherein the processor is located remotely from the head- attachable device, connected thereto wirelessly.
  10. 10. The apparatus of claim 7, wherein the processor is incorporated in the head- attachable device.
  11. 11. The apparatus of claim 10, wherein the head-attachable device comprises a wearable headset.
  12. 12. The apparatus of claim 6, wherein the head-attachable device comprises a wearable headset.
  13. 13. The apparatus of claim 7, in combination with a smart phone, the apparatus and the smart phone having wireless communication capability so that the smart phone displays and reports any said increase in frequency content.

Description

A METHOD OF DETERMINING RECOVERY FROM CONCUSSION S P E C I F I C A T I O N Background of the Invention The invention concerns a method of determining when a subject has suffered a concussive injury and when that subject has recovered from that injury and can safely return to activity. This is assessed using a headset system, the HeadPulse signal, and one or more algorithms. The HeadPulse derives its signal from brain motion and is not subjective, it does not require the subject to cooperate and detection of a concussive injury and recovery from a concussive injury can be carried out on sleeping, unconscious or awake subjects. The non- invasive headset can be placed for a single recording, multiple recordings or worn continuously. Another aspect of the invention is to provide a monitor of head motion to provide input to the algorithm that determines the subject has recovered from a concussive injury. Another aspect of the invention is to assure integrity of remote monitoring of concussion recovery. The terms “concussion” and “mild Traumatic Brain Injury (mTBI)” are used interchangeability in this document. Concussion is defined clinically and is diagnosed by sports medicine trained professionals including emergency physicians, team physicians, coaches, team trainers, physical therapists and others. The term “concussive injury” refers to pathological changes in the brain following a concussion. “Subconcussive Injury” is brain injury sustained due to external forces applied to the brain that do not lead to symptoms of concussion. The unit mg herein stands for mili-g or 0.001 g where g is the acceleration of gravity, 1 g = 9.8m/s2. Traumatic brain injury (TBI) causes significant morbidity and mortality with an annual global incidence exceeding 60 million. One third of injuries are sports related with predilection for young adults. The vast majority of TBI is technically classified as ‘mild’ using current diagnostic criteria. Concussion is a subset of TBI and symptoms include headache, vestibular impairment, visual changes, cognitive symptoms, mood changes, and sleep disturbance. A second concussion during recovery can be neurologically deleterious and in rare cases fatal (‘second impact syndrome’). Repetitive concussive or asymptomatic sub -concussive events are also associated with delayed onset neurobehavioral impairment and subsequent neuropathological findings of chronic traumatic encephalopathy (CTE) and other neurodegenerative conditions. Risk factors for repetitive head injury and CTE are well described in the literature and include collision sports. To mitigate these risks, most organized sports teams utilize concussion protocols which prohibit return to play before recovery which is also clinically determined. Objective identification of concussive injury, asymptomatic sub concussive injury, and definitive recovery is critical to mitigate both short and long-term impairment and remains an unmet need. There exists a digital biomarker derived from cranial accelerometry (CA) which draws on principles of ballistocardiography first recognized in the 19th century. Ballistocardiography measures whole body forces produced by cardiac contraction. Similarly, the motion of the brain due to the cardiac cycle and its induced inflow and outflow of blood in the brain can be measured on the scalp using sensitive accelerometers or other sensor. Herein this is called the ‘HeadPulse’ and it has previously been shown that frequency domain analysis of the HeadPulse supports a diagnosis of concussive injury and recovery from concussive injury. HeadPulse abnormalities, when processed through the appropriate algorithm, can provide diagnosis — moderate to severe TBI, large vessel occlusion (LVO) stroke, intracranial hemorrhage (ICH), seizure, migraine, cerebral vasospasm, and onset of edema following a cardiac arrest, among other neurological conditions. Analysis of the HeadPulse signal can indicate when a person has suffered a concussive injury. By processing the HeadPulse signal through a concussion algorithm, various “biometric parameters” are generated that correlate with the diagnosis of recent concussion. We use the term “biometric concussion” to indicate that HeadPulse recordings from an individual significantly exceed values derived from normal, non-concussed individuals and “biometric onset” to indicate the time at which the first recording met the biometric concussion definition. This biometric concussion signal appears after a clinically determined concussion and returns to normal when sufficient time has elapsed and the subject has healed. The time to return to normal varies by how severe the concussion was and how an individual heals. The Zurich Protocol was developed to help determine when a concussed subject can return to activity. This protocol uses a symptom survey of 22 physiological indicators (Sport Concussion Assessment Tool 2 or SCAT2) such as trouble sleeping, headaches, balance or trouble focusing