Evoked response testing system for neurological disorders

• US 9,675,292 B2
• Filed: 01/10/2014
• Issued: 06/13/2017
• Est. Priority Date: 06/18/2004
• Status: Active Grant

• Current Assignee: Neuronetrix, Inc.
• Original Assignee: Neuronetrix, Inc.
• Inventors: Fadem, Kalford C.
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): TRAN, THO Q
• Application Number:
  US14/152,207
• Publication Number:
  US 20140128763A1
• Time in Patent Office: 1,250 Days
• Field of Search: 600544, 600545
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/165 Evaluating the state of mind, e.g. depression, anxiety
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/378 Visual stimuli
• CPC Class Codes: A61B 5/38 Acoustic or auditory stimuli
• CPC Class Codes: A61B 5/6814 Head

Abstract

A dyslexia screening system suitable for clinical use includes an integrated headset that efficiently and conveniently performs an auditory evoked response (ERP) test by positioning electrodes about the ears of the subject. An integral control module automatically performs the test, providing simplified controls and indications to the clinician. A number of screening tests that are stored in the headset are periodically uploaded for billing, remote analysis and result reporting. A paradigm that characterizes testing performed for a subject along with the patient identification and/or patient demographics are stored in an associated fashion for later fusion and analyses with similar but not necessarily identically constructed ERP tests.

Claims

1. A method of using an Evoked Response Potential (ERP) testing system to administer a test on a test subject, wherein the ERP testing system comprises a headset, the method comprising:

(a) positioning the headset on the head of the test subject, wherein the headset comprises;

(i) a signal electrode,

(ii) a reference electrode,

(iii) a stimulus producer,

(iv) a semi-rigid frame with a left ear cup and a right ear cup, wherein the semi-rigid frame is curved such that. as the semi-rigid frame flexes as a result of increasing the distance between the left ear cup and the right ear cup, the orientation of the left ear cup and the right ear cup do not change with respect to the head,

(v) a control module contained within the semi-rigid frame, and

(vi) a forehead frame configured to align with the eyebrows of the head, wherein aligning the forehead frame with the eyebrows results in proper placement of the plurality of electrodes;

(b) providing the test subject with access to one or more buttons on the control module, wherein the control module further comprises;

(i) a memory, wherein the memory stores a plurality of evoked response testing protocols including instructions for the stimulus producer, and

(ii) a controller operably configured to actuate one of the plurality of evoked response testing protocols stored in the memory, wherein the controller is further configured to communicate a plurality of control administration parameters to the headset for performing an evoked response test;

(c) executing a selected one of the stored evoked response testing protocols though the headset via the controller, wherein all of the functionality required to perform the selected one of the stored evoked response testing protocols is included in the headset;

(d) receiving manual inputs from the test subject via the one or more buttons on the control module;

(e) receiving a stimulated EEG result via the signal electrode; and

(f) recording data in the memory based on the manual inputs received from the test subject and the stimulated EEG result.

2. The method of claim 1, wherein the act of executing a selected one of the stored evoked response testing protocols though the headset via the controller comprises selectively activating the stimulus producer, wherein the act of receiving manual inputs from the test subject comprises receiving one or more manual inputs in response to one or more stimuli from the stimulus producer.

3. The method of claim 1, wherein the act of receiving manual inputs from the test subject comprises receiving a manual input to initiate the execution of the selected one of the stored evoked response testing protocols.

4. The method of claim 1, wherein the stimulus producer is operable to provide a visual stimulus to the test subject, wherein the act of executing a selected one of the stored evoked response testing protocols comprises providing a visual stimulus to the test subject via the stimulus producer.

5. The method of claim 1, wherein the stimulus producer is operable to provide an auditory stimulus to the test subject, wherein the act of executing a selected one of the stored evoked response testing protocols comprises providing an auditory stimulus to the test subject via the stimulus producer.

6. The method of claim 5, wherein the auditory stimulus is selected from a set of auditory stimulus files having characteristics that vary based on one or more of acoustic frequency, time duration, stimuli sequence, or time warp, wherein time warp denotes a selected sound stimulus having a lengthened duration and an unchanged pitch or changed pitch with unchanged duration.

7. The method of claim 1, wherein the plurality of control administration parameters are selected from a group consisting of a stimuli start time, a stimuli selection, a stimuli sequence, a failure determination, and sample mode.

8. The method of claim 1, further comprising coupling the control module with a remote storage system.

9. The method of claim 8, further comprising transmitting control administration parameters from the remote storage system to the control module.

10. The method of claim 8, further comprising transmitting data recorded in the memory from the control module to the remote storage system.

11. The method of claim 10, further comprising using the remote storage system to perform ERP diagnostic analyses on the data transmitted from the control module to the remote storage system.

12. The method of claim 1, wherein the memory further stores a paradigm logic library containing a plurality of testing paradigms, wherein the memory further stores a stimulus library containing a plurality of stimuli, wherein the act of executing a selected one of the stored evoked response testing protocols comprises:

(i) accessing a selected testing paradigm contained in the paradigm logic library stored in the memory,

(ii) accessing stimuli specified by the selected testing paradigm contained in the stimulus library stored in the memory,

(iii) calculating sequence and interstimulus delays between selected stimuli in accordance with the selected testing paradigm, and

(iv) outputting a testing stream to the headset.

13. The method of claim 1, further comprising:

(a) detecting an artifact in data associated with manual inputs received from the test subject;

(b) accessing an epoch grouping of stimuli associated with the artifact; and

(c) replaying the associated epoch grouping.

14. The method of claim 1, further comprising processing the recorded data based on a predetermined neurological diagnosis associated with the test subject.

15. The method of claim 14, wherein the act of processing the recorded data based on a predetermined neurological diagnosis associated with the test subject comprises refining a selected evoked response testing protocol.

18. The method of claim 1, wherein the headset further comprises a control box, wherein positioning the headset further comprises:

(a) using one or more physical indicators on the semi-rigid frame to properly position the headset;

(b) performing a self test to check electrode continuity; and

(c) displaying a detailed explanation of the self test results via a display on the control box.

19. The method of claim 18, further comprising:

(a) in response to a self test pass, locating a machine readable patient identification;

(b) interpreting the machine readable patient identification via an identification input on the control box; and

(c) verifying the machine readable patient identification and associating it with data recorded in the memory.

16. A method of using an Evoked Response Potential (ERP) testing system to administer a test on a test subject, wherein the ERP testing system comprises a headset, the method comprising:

(a) positioning the headset on the head of the test subject, wherein the headset comprises;

(i) a signal electrode,

(ii) a reference electrode,

(iii) a stimulus producer,

(iv) a semi-rigid frame,

(v) a control module contained within the semi-rigid frame, and

(vi) a forehead frame configured to align with the eyebrows of the head, wherein aligning the forehead frame with the eyebrows results in proper placement of the plurality of electrodes;

(b) placing a handheld control box in a hand of the test subject, wherein the handheld control box further comprises;

(i) a memory, wherein the memory stores a plurality of evoked response testing protocols including instructions for the stimulus producer, and

(ii) a controller operably configured to actuate one of the plurality of evoked response testing protocols stored in the memory, wherein the controller is further configured to communicate a plurality of control administration parameters to the headset for performing an evoked response test;

(c) performing an ERP test, wherein the act of performing an ERP test comprises;

(i) performing a self-test via the headset to verify good reception of an EEG signal,

(ii) pausing the ERP test until a patient identification associated with the test subject is received by the headset and then automatically resuming,

(iii) measuring a resting EEG result via the signal electrode and imposing a threshold delay if the resting EEG result is not below a threshold indicating a resting state,

(iv) when the slope of the resting EEG result meets a criteria indicating a resting state, presenting a stimulus via the stimulus producer while measuring a stimulated EEG result, and

(v) analyzing the stimulated EEG result via the signal electrode for artifacts, and imposing an artifact delay and re-measuring the stimulated EEG result if artifacts are present;

(d) placing the headset in communication with a computer and transferring an electronic medical record and the stimulated EEG result to the computer; and

(e) upon a successful data transfer, clearing the headset memory of the electronic medical record and the stimulated EEG result.

20. The method of claim 16 wherein the headset is configured to be able to produce a plurality of stimuli including at least one of the following:

(a) a click characterized by a narrow band spike;

(b) a burst characterized by a broadband short duration;

(c) a chirp characterized by a single frequency half-cycle carrier;

(d) a steady-state tone characterized by a single frequency constant amplitude;

(e) a master characterized by a single frequency continuous cycle;

(f) a phoneme characterized by a single-phoneme speech sound;

or

(g) a spoken word; and

wherein the headset is configured to be able to produce the plurality of stimuli in a plurality of sequences including at least one of the following;

(i) repeating a single stimuli;

(ii) a single tone with a long duration;

(iii) multiple stimuli with each repeated an equal number of times;

(iv) a pair of stimuli, presented with minimal interstimulus delay, which either match or do not match;

(v) a single standard stimuli with one or more deviant stimuli;

(vi) a constant volume with varying frequency;

(vii) a constant frequency with varying volume;

(viii) a constant tone with varying duration;

or

(ix) a user defined sequence presentation, volume, tone, and time warp.

17. A method of using an Evoked Response Potential (ERP) testing system to administer a test on a human child, wherein the ERP testing system comprises a headset, the method comprising:

(a) positioning the headset on the head of the child, wherein the headset comprises;

(i) a plurality of flexible arms cantilevered to exert force upon a plurality of electrodes and place them in contact with the head,

(ii) the plurality of electrodes comprising a reference electrode, a signal electrode, and a plurality of fluid-filled bladders configured to reduce discomfort and provide uniform contact between the head and the plurality of electrodes,

(iii) a stimulus producer,

(iv) a semi-rigid frame with a left ear cup and a right ear cup, wherein the semi-rigid frame is curved such that. as the semi-rigid frame flexes as a result of increasing the distance between the left ear cup and the right ear cup, the orientation of the left ear cup and the right ear cup do not change with respect to the head,

(v) a control module contained within the semi-rigid frame; and

(vi) a forehead frame configured to align with the eyebrows of the head, wherein aligning the forehead frame with the eyebrows results in proper placement of the plurality of electrodes;

(b) placing a handheld control box in a hand of the child, wherein the handheld control box further comprises;

(i)a memory, wherein the memory stores a plurality of evoked response testing protocols including instructions for the stimulus producer, and

(ii) a controller operably configured to actuate one of the plurality of evoked response testing protocols stored in the memory, wherein the controller is further configured to communicate a plurality of control administration parameters to the headset for performing an evoked response test;

(c) performing an ERP test, wherein the act of performing an ERP test comprises executing a selected one of the stored evoked response testing protocols though the headset via the controller, wherein all of the functionality required to perform the selected one of the stored evoked response testing protocols is included in the headset and the handheld control box;

(d) receiving results of the ERP test, wherein the act of receiving results of the ERP test comprises receiving manual inputs from the child via the one or more buttons on the handheld control box during the act of performing an ERP test and receiving a stimulated EEG result via the plurality of electrodes; and

(e) recording the ERP test results in the memory.