Neuro-behavioral test method for screening and evaluating therapy for ADHD and system

• US 8,473,043 B1
• Filed: 06/16/2006
• Issued: 06/25/2013
• Est. Priority Date: 12/22/2004
• Status: Expired due to Fees

• Current Assignee: Cleveland Medical Devices Inc.
• Original Assignee: NeuroWave Systems Inc.
• Inventors: Modarres, Mo
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US11/454,485
• Time in Patent Office: 2,566 Days
• Field of Search: 600/544, 600/545
• US Class Current: 600/544
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/168 Evaluating attention deficit, hyperactivity
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/374 Detecting the frequency distribution of signals, e.g. detecting delta, theta, alpha, beta or gamma waves
• CPC Class Codes: A61B 5/377 using evoked responses
• CPC Class Codes: A61B 5/378 Visual stimuli
• CPC Class Codes: A61B 5/38 Acoustic or auditory stimuli
• CPC Class Codes: A61B 5/4088 Diagnosing of monitoring cognitive diseases, e.g. Alzheimer, prion diseases or dementia
• CPC Class Codes: A61B 5/4806 Sleep evaluation A61B5/4821 takes precedence; devices for inducing sleep A61M21/02
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication

Abstract

A new neuro-behavioral test with analysis algorithms has been developed for use in screening individuals for attention deficit hyperactivity disorder (ADHD) and for the quantitative evaluation of ADHD medication/therapy in diagnosed patients. This technique combines a 15 minute auditory-based test of attention with simultaneous EEG monitoring by a wireless, portable data acquisition device. This system acquires both behavioral response (i.e., reaction times to target stimuli, as well as errors of omission/commission) and EEG waveforms. All of the data is simultaneously processed by the algorithms to produce several representative indices. These indices are then combined to produce an overall neuro-behavioral index that represents the degree by which both “behavioral” and “EEG” attention is maintained throughout the test.

Claims

1. A method of screening for attention deficit hyperactivity disorder (ADHD) comprising the steps of:

a) measuring and, with a computer processor, analyzing EEG signals from a subject over a measurement time period;

b) measuring and, with a computer processor, analyzing a non-EEG response of the subject to a stimulus over the measurement time period; and

c) determining whether the subject has ADHD based in part on the analyzed EEG signals and in part on the analyzed non-EEG response of the subject to a stimulus.

2. The method in claim 1, wherein the measurement period is less than 2 hours.

3. The method in claim 2, wherein the measurement period is less than 60 minutes.

4. The method in claim 1, wherein the step of determining whether the subject has ADHD is performed by determining the distance between a first point given by an index computed from the analyzed EEG signals versus an index computed from the analyzed non-EEG response of the subject to a stimulus and a second point.

5. The method in claim 1, wherein the stimulus is supplied and the non-EEG response is measured and analyzed according to a modified odd-ball paradigm.

6. The method in claim 1, wherein the stimulus is a video device.

7. A method of therapeutically treating a subject for attention deficit hyperactivity disorder (ADHD) comprising the steps of:

a) quantitatively analyzing, with a computer processor, a subject'"'"'s brain wave signals and using the quantitative analysis in estimating or determining whether the subject has ADHD;

b) making a physical change to the subject or giving the subject a medication to make an improvement to the subject'"'"'s ADHD based in part on the quantitative analysis;

c) quantitatively analyzing a second time the subject'"'"'s brain wave signals to estimate or determine the extent of the improvement to the subject'"'"'s ADHD; and

d) if necessary, making an additional physical change to the subject or reducing or increasing the medication in response to the previous step.

8. The method in claim 7, further including a step of providing one or more types of stimulus to the subject.

9. The method in claim 8, wherein the subject is instructed to respond after recognizing one or more of the types of stimulus.

10. The method in claim 9, further including the step of measuring the subject'"'"'s response to one or more types of stimulus and wherein the stimulus is provided on an intermittent basis.

11. The method in claim 7, wherein the subject is given medication and the amount of medication is increased based on the results of quantitatively analyzing the subject a second time.

12. The method in claim 7, wherein the subject is given medication and the amount of medication is decreased based on the results of quantitatively analyzing the subject a second time.

13. The method in claim 9, wherein the subject is given medication and the amount of medication is increased based on the results of quantitatively analyzing the subject a second time.

14. The method in claim 9, wherein the subject is given medication and the amount of medication is decreased based on the results of quantitatively analyzing the subject a second time.

15. A method of analyzing a subject for attention deficit hyperactivity disorder (ADHD) comprising the steps of:

a) placing electrodes onto a subject'"'"'s head having a brain wave signal;

b) providing a stimulus to the subject;

c) measuring the subject'"'"'s non-brain-wave response to the stimulus and the brain wave signal;

d) analyzing the brain wave signal with a computer processor; and

e) making a determination that the subject has ADHD based in part on the brain wave signal analysis over a period of time, and in part on the subject'"'"'s non-brain-wave response to the stimulus over the period of time.

16. The method in claim 15, wherein the stimulus is one or more auditory stimulus.

17. The method in claim 16, wherein the measured brain wave signal is filtered before analyzing.

18. The method in claim 17, wherein the stimulus is provided on an intermittent basis.

19. The method in claim 18, wherein a power spectrum profile is estimated or determined for each time segment of the analyzed brain wave signal, the power spectrum profile comprising an alpha component and one or more sub-alpha components and a ratio is calculated of the one or more sub-alpha components to the alpha component.

20. The method in claim 19, wherein the determination that the subject has ADHD is based in part on an average of the ratio of the one or more sub-alpha components to the alpha component either exceeding a predetermined threshold number over a period of time or a profile of the ratio over a period of time.