# US 11,076,798 B2 · System and method for non-invasive and non-contact measurement in early therapeutic intervention > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,076,798 B2 - Document ID: US11076798B2 - Status: Granted - Kind: B2 - Application number: 15/766,805 - Filed: 2016-10-11 - Published: 2018-10-18 - Granted: 2021-08-03 - Earliest claimed: 2015-10-09 - Assignees: I2Dx, Inc. - Applicants: I2Dx, Inc. - Inventors: Matthew J. Johnson; Janos Redei; Ethan C. Green - Web page: https://patentgrep.com/patent/US11076798B2 ## CPC - A61B 5/4082: {Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette} - A61B 5/0022: {Monitoring a patient using a global network, e.g. telephone networks, internet} - A61B 5/0077: {Devices for viewing the surface of the body, e.g. camera, magnifying lens} - A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20) - A61B 5/1101: {Detecting tremor} - A61B 5/1112: {Global tracking of patients, e.g. by using GPS} - A61B 5/1114: {Tracking parts of the body} - A61B 5/1172: using fingerprinting - A61B 5/4011: {Evaluating olfaction, i.e. sense of smell} - A61B 5/4833: {Assessment of subject's compliance to treatment} - A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication} - A61B 6/037: {Emission tomography} - G06F 16/951: Indexing; Web crawling techniques - G16H 10/60: for patient-specific data, e.g. for electronic patient records - G16H 40/67: for remote operation - H04L 63/0876: {based on the identity of the terminal or configuration, e.g. MAC address, hardware or software configuration or device fingerprint} - A61B 5/7257: {using Fourier transforms} - A61B 2560/0233: Optical standards - A61B 2562/0204: Acoustic sensors - A61B 2562/0219: Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches - A61B 2562/0257: Proximity sensors - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N) - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA - H04L: TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION (arrangements common to telegraphic and telephonic communication H04M) ## Abstract A system and method for non-invasive and/or non-contact measurement of a subject's tremor in the context of therapeutic intervention is presented. The system includes a memory, a communications interface, a sensor to measure a signal associated with position or motion of an extremity of the subject, and a processor. The processor is configured to receive the signal from the sensor. The processor is further configured to communicate, via the communications interface, the signal, login credentials, and position or motion data to a remote server coupled to a remote electronic health record database. The remote server is configured to receive the signal and perform an analysis that quantifies a severity of tremor based on the position or motion signals of the subject. The processor is configured to receive the analysis that quantified the severity of tremor and cause the quantified severity of tremor to be displayed via a display device. ## Claims ### Claim 1 A system, comprising: a memory; a communications interface; at least one sensor to measure a signal associated with position or motion of an extremity of a subject, wherein the at least one sensor includes a portable optical sensor and wherein the portable optical sensor is qualified for accuracy by: using a tremor simulator device that includes a hand phantom capable to produce a simulated movement of a human hand; measuring movement of the hand phantom using the at least one sensor and an alternate method of measuring position and motion; comparing the results of the at least one sensor with the alternate method of measuring position and motion; and determining to qualify the at least one sensor based on the comparison of the results and based on at least one statistical analysis metric indicative of reproducible accuracy, wherein the at least one sensor is qualified based on the least one statistical analysis metric meeting a predetermined threshold; and a processor operatively coupled to the memory, the communications interface, and the sensor, wherein the processor is configured to perform operations comprising: receive the signal from the sensor; communicate, via the communications interface, the signal, login credentials, and position or motion data to a remote server, wherein the remote server is configured to receive the signal and perform an analysis that quantifies a severity of tremor based on the position or motion signals of the subject; receive the analysis that quantified the severity of tremor; and cause the quantified severity of tremor to be displayed via a display device. ### Claim 2 (depends on 1) The system of claim 1, wherein at least one of the sensors is not in physical contact with the extremity to record the position or motion of the extremity. ### Claim 3 (depends on 2) The system of claim 2, wherein said measurement of the subject's tremor is applied to early therapeutic intervention in Parkinson's Disease. ### Claim 4 (depends on 3) The system of claim 3, wherein the processor is further configured to: a) at least partially identify a clinical drug candidate in pharmaceutical development by confirming therapeutic target engagement in-vivo, b) at least partially screen for and diagnose early disease such as prodromal Parkinson's Disease, or c) enable in-office as well as home and portable monitoring of therapeutic interventions. ### Claim 5 (depends on 1) The system of claim 1, wherein the remote server is coupled to an electronic health records database, wherein the electronic health records database is configured to store and maintain the subject's resulting analysis and signal from the remote server for an individual user associated with login credentials for identity verification, wherein the remote server is configured to send the resulting analysis to the electronic health records database. ### Claim 6 (depends on 5) The system of claim 5, wherein the electronic health records database includes a records server that is configured to generate a database, in response to the receipt of subject results and analysis from the remote server, wherein the records server includes a processor to perform operations comprising: maintain in memory the signals received from the remote server that include the analysis of and signals used to quantify tremor severity; generate a database that includes subject data that is associated and stored, according to the login credentials; and output, as a result of a query, the analysis and signals from the database in electronic form to a remote platform for viewing provided that correct login credentials are provided. ### Claim 7 (depends on 2) The system of claim 2, wherein the qualification is for early therapeutic intervention in Parkinson's Disease. ### Claim 8 A system, comprising: a memory; a communications interface; and a processor operatively coupled to the memory, the communications interface, and a peripheral sensor, wherein the peripheral sensor includes an optical sensor configured to measure a signal associated with position or motion of an extremity of a subject and wherein the peripheral sensor is qualified for accuracy by: using a dynamic human hand tremor simulator device that includes a hand phantom capable to produce a reproducible movement; measuring movement of the hand phantom using the peripheral sensor and an alternate method of measuring position and motion; comparing the results of the peripheral sensor with an alternate method of measuring position and motion; and determining to qualify the peripheral sensor based on the comparison of the results by at least one of a statistical analysis or a graphical analysis, wherein the processor is configured to perform operations comprising: receive a signal from the peripheral sensor; confirm signal integrity by obtaining at least one metric including a metric of steady positioning of the extremity during measurement in a predefined measurement volume; communicate, via the communications interface, the signal, login credentials, and position or motion data to a remote server, wherein the remote server is configured to receive the signal and perform an analysis that quantifies a severity of tremor based on the position or motion signals of the subject; receive the analysis that quantified the severity of tremor; and cause the quantified severity of tremor to be displayed via a display device. ### Claim 9 (depends on 8) The system of claim 8, wherein the peripheral sensor is not in physical contact with the extremity to record the position or motion of the extremity. ### Claim 10 (depends on 9) The system of claim 9, wherein said measurement of a subject's tremor is applied to early therapeutic intervention in Parkinson's Disease. ### Claim 11 (depends on 10) The system of claim 10, wherein the processor is further configured to at least partially identify a clinical drug candidate in pharmaceutical development by confirming therapeutic target engagement in-vivo. ### Claim 12 (depends on 10) The system of claim 10, wherein the processor is further configured to at least partially screen for and diagnose early disease such as prodromal Parkinson's Disease. ### Claim 13 (depends on 10) The system of claim 10, wherein the processor is further configured to enable in-office and home and portable monitoring of therapeutic interventions. ### Claim 14 (depends on 8) The system of claim 8, wherein the remote server is coupled to an electronic health records database, wherein the electronic health records database is configured to store and maintain the subject's resulting analysis and signal from the remote server for an individual user associated with the login credentials for identity verification, wherein the remote server is configured to send the resulting analysis to the electronic health records database. ### Claim 15 (depends on 14) The system of claim 14, wherein the electronic health records database includes a records server that is configured to generate a database, in response to the receipt of subject results and analysis from the remote server, wherein the records server includes a processor to perform operations comprising: maintain in memory the signals received from the remote server that include the analysis of and signals used to quantify tremor severity; generate a database that includes individual data that is associated and stored, according to the login credentials; and output, as a result of a query, the analysis and signals from the database in electronic form to a remote platform for viewing provided that correct login credentials are provided. ### Claim 16 (depends on 9) The system of claim 9, wherein the qualification is for early therapeutic intervention in Parkinson's Disease. ### Claim 17 A method, comprising: receiving, from at least one sensor, a signal indicative of a change in position or motion of an extremity of a subject, wherein one of the sensors is a portable optical sensor or a wearable sensor, wherein the sensor is qualified for accuracy by: using an artificial hand tremor simulator that includes a human hand phantom capable to produce a reproducible movement; comparing the results of the at least one sensor with an alternate method of measuring position and motion; and determining to qualify the at least one sensor based on the comparison of the results; communicating, via a communications interface, the signal, login credentials, and position or motion data to a processor coupled to a remote electronic health record database, wherein the processor is configured to receive the signal and perform an analysis that quantifies a severity of tremor based on the position or motion signals of the subject; receiving the analysis that quantified the severity of tremor; and causing the quantified severity of tremor to be displayed via a display device. ### Claim 18 (depends on 17) The method of claim 17, wherein one of the sensors is not in physical contact with the extremity to record the position or motion of the extremity. ### Claim 19 (depends on 17) The method of claim 17, wherein an already qualified sensor is used as the alternate method of measuring position and motion to qualify additional sensors to be distributed for use in clinical drug development or clinical practice. ### Claim 20 (depends on 17) The method of claim 17, wherein the quantified tremor severity is further combined with an olfactory test and/or genetic data to direct patients to dopamine transporter single photon emission tomography (DAT-SPECT) imaging. ### Claim 21 (depends on 1) The system of claim 1, wherein the at least one statistical analysis metric indicative of accuracy includes a correlation coefficient R-squared for linear regression of dominant tremor frequency obtained with the sensor versus frequency determined by the alternate method, and whereas R-squared is greater than or about 0.99. ### Claim 22 (depends on 8) The system of claim 8, wherein the peripheral sensor is qualified based on a comparison of tremor frequencies of the hand phantom with known predetermined frequencies. ### Claim 23 (depends on 8) The system of claim 8, wherein the reproducible movement is generated by a linear actuator.