METHOD AND APPARATUS FOR DETERMINING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) MEDICATION DOSAGE AND FOR MONITORING THE EFFECTS OF ADHD MEDICATION ON PEOPLE WHO HAVE ADHD USING COMPLEMENTARY TESTS

• US 6,726,624 B2
• Filed: 03/06/2002
• Issued: 04/27/2004
• Est. Priority Date: 03/06/2002
• Status: Expired due to Fees

• Current Assignee: Mclean Hospital (Mass General Brigham, Inc.)
• Original Assignee: Mclean Hospital (Mass General Brigham, Inc.)
• Inventors: Keirsbilck, Richard S., Parks, Peter A., Miller, Paige, Blazey, Richard N., Patton, David L.
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): MCCROSKY, DAVID J
• Application Number:
  US10/092,284
• Publication Number:
  US 20030171658A1
• Time in Patent Office: 783 Days
• Field of Search: 600/300, 600/301, 600/474, 600/549
• US Class Current: 600/300
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/168 Evaluating attention deficit, hyperactivity
• CPC Class Codes: A61B 5/7257 using Fourier transforms
• CPC Class Codes: A61B 5/726 using Wavelet transforms

Abstract

A method for determining the appropriate dosage of a medication to treat Attention Deficit Hyperactivity Disorder (ADHD) in an individual who has ADHD. The method comprises sampling the peripheral skin temperature of left and right like extremities of an individual during a predetermined time interval when the individual is in a sensory deprived state to provide respective left and right sampled peripheral skin temperature data; processing the sampled peripheral skin temperature data; processing the sampled peripheral skin temperature data including filtering, differentiation, and conversion to the frequency domain to derive spectral signatures whose magnitudes are indicative of the level of ADHD manifestation. The effectiveness of the medication is calculated by comparison to predetermined threshold values.

Claims

1. A method for determining the appropriate dosage of a medication to treat Attention Deficit Hyperactivity Disorder (ADHD) in an individual who has ADHD comprising:

(a) sampling the peripheral skin temperature of left and right like extremities of an individual during a predetermined time interval when the subject is in a sensory deprived state to provide respective left and right sampled peripheral skin temperature data;

(b) a first processing of at least one of said left and right sampled peripheral skin temperature data providing conversion to the frequency domain to derive a first spectral signature having magnitude values;

(c) a second processing of both said left and right sampled peripheral skin temperature data to derive temporally correlated differential data;

(d) said second processing further filtering said differential data with a high pass filter to produce filtered differential data with near d. c. components removed;

(e) said second processing lastly providing conversion to the frequency domain of said filtered differential data to derive a second spectral signature having magnitude values;

(f) a third processing of the said first spectral signature for the determination of the level of manifestation of ADHD by comparison to a predetermined first threshold value;

(g) a fourth processing of the said second spectral signature for the determination of the level of manifestation of ADHD by comparison to a predetermined threshold value; and

(h) a fifth processing wherein an assessment of the bi-modal quality of the results of the third and fourth processing is made, to provide a final determination of one of the following three possibilities;

(i) a various level of dosage change;

(ii) dosage level is adequate;

(iii) there is noise in the data.

2. The method of claim 1 wherein said level of dosage change of the said final determination is calculated by comparisons of the magnitudes of said first and second spectral signatures with respective predetermined first and second threshold values using mathematical equations that can resolve anywhere within a gradient of ADHD manifestation for each said comparison, such that said level of dosage change is a function of how great is the difference between respective said magnitudes and said threshold values.

3. The method of claim 1 wherein the said comparisons must correlate by indicating substantially the same level of dosage change for such said final determination to be acceptable.

4. The method of claim 3 wherein the absence of a substantial correlation determines that there is noise in the data.

5. The method of claim 1 wherein in comparing said first spectral signature magnitude values to said predetermined first threshold value, if said first spectral signature magnitude value is greater than said predetermined first threshold value, the proper dosage of medication is partially determined, and if said second spectral signature magnitude value is lesser than said predetermined second threshold value, proper dosage of medication is totally determined.

6. The method of claim 1 wherein said left and right like extremities sampled are the pair of said individual'"'"'s two hands or two feet.

7. The method of claim 6 wherein one or more digits of each of said pair are sampled during said sampling.

8. The method of claim 1 wherein said left and right extremities sampled are said individual'"'"'s ears.

9. The method of claim 1 wherein said differential data is derived by subtracting one of said left and right sampled data from the other of said left and right sampled data.

10. The method of claim 1 wherein said high-pass filter used in said filtering is a Butterworth High-Pass Infinite Impulse Response (IIR) Filter.

11. The method of claim 1 wherein said second spectral signature has a spectral response of interest which is centered around approximately 0.03 Hz.

12. The method of claim 1 including a headphone adapted to be worn by the subject during said predetermined time interval to block out ambient noise or to receive white noise to reduce or eliminate audio stimulus from the ambient environment during said time interval.

13. The method of claim 12 including a source of white noise coupled to said headphone to provide white noise during said predetermined time interval.

14. The method of claim 1 including providing glasses or goggles adapted to be worn by the subject during said predetermined time interval to block out or eliminate ambient visual stimulus from the ambient environment during said time interval.

15. The method of claim 14 including presenting a uniformly illuminated visual field to the individual during said predetermined time interval to minimize the human propensity to self-stimulate with mental imagery.

16. The method of claim 1 wherein different threshold values are used for each of both genders.

17. The method of claim 1 wherein different threshold values are used for each of different age groups.

18. The method of claim 1 including administering a dosage of medication to an individual being tested;

repeating at temporally evenly spaced intervals the sampling and first through fifth processing; and

producing a profile of the efficacy over time of said medication by tabulating the results obtained at said temporally evenly spaced intervals.

19. The method of claim 18 including concluding said testing when the results indicate that the effect of the ingested medication has ceased.

20. Apparatus for determining the appropriate dosage of a medication to treat Attention Deficit Hyperactivity Disorder (ADHD) in an individual who has ADHD comprising:

a device for sampling the peripheral skin temperature of left and right like extremities of an individual during a predetermined time interval when the subject is in a sensory deprived state to provide respective left and right sampled peripheral skin temperature data; and

a processor for carrying out;

a first processing of at least one of said left and right sampled peripheral skin temperature data providing conversion to the frequency domain to derive a first spectral signature having magnitude values;

a second processing of both said left and right sampled peripheral skin temperature data to derive temporally correlated differential data;

said second processing further filtering said differential data with a high pass filter to produce filtered differential data with near d. c. components removed;

said second processing lastly providing conversion to the frequency domain of said filtered differential data to derive a second spectral signature having magnitude values;

a third processing of the said first spectral signature for the determination of the level of manifestation of ADHD by comparison to a predetermined first threshold value;

a fourth processing of the said second spectral signature for the determination of the level of manifestation of ADHD by comparison to a predetermined threshold value; and

a fifth processing wherein an assessment of the hi-modal quality of the results of the third and fourth processing is made, to provide a final determination of one of the following three possibilities;

a various level of dosage change;

dosage level is adequate;

there is noise in the data.

21. The apparatus of claim 20 wherein said level of dosage change of the said final determination is calculated by comparisons of the magnitudes of said first and second spectral signatures with respective predetermined first and second threshold values using mathematical equations that can resolve anywhere within a gradient of ADHD manifestation for each said comparison, such that said level of dosage change is a function of how great is the difference between respective said magnitudes and said threshold values.

22. The apparatus of claim 21 wherein the said comparisons must correlate by indicating substantially the same level of dosage change for such said final determination to be acceptable.

23. The apparatus of claim 21 wherein the absence of a substantial correlation determines that there is noise in the data.

24. The apparatus of claim 20 wherein in comparing said first spectral signature magnitude values to said predetermined first threshold value, if said first spectral signature magnitude value is greater than said predetermined first threshold value, the proper dosage of medication is partially determined, and if said second spectral signature magnitude value is lesser than said predetermined second threshold value, proper dosage of medication is totally determined.

25. The apparatus of claim 20 wherein said left and right like extremities sampled are the pair of said individual'"'"'s two hands or two feet.

26. The apparatus of claim 25 wherein one or more digits of each of said pair are sampled during said sampling.

27. The apparatus of claim 20 wherein said left and right extremities sampled are said individual'"'"'s ears.

28. The apparatus of claim 20 wherein said differential data is derived by subtracting one of said left and right sampled data from the other of said left and right sampled data.

29. The apparatus of claim 20 wherein said high-pass filter used in said filtering is a Butterworth High-Pass Infinite Impulse Response (IIR) Filter.

30. The apparatus of claim 20 wherein said second spectral signature has a spectral response of interest which is centered around approximately 0.03 Hz.

31. The apparatus of claim 20 including a headphone adapted to be worn by the subject during said predetermined time interval to block out ambient noise or to receive white noise to reduce or eliminate audio stimulus from the ambient environment during said time interval.

32. The apparatus of claim 31 including a source of white noise coupled to said headphone to provide white noise during said predetermined time interval.

33. The apparatus of claim 20 including providing glasses or goggles adapted to be worn by the subject during said predetermined time interval to block out or eliminate ambient visual stimulus from the ambient environment during said time interval.

34. The apparatus of claim 33 including presenting a uniformly illuminated visual field to the individual during said predetermined time interval to minimize the human propensity to self-stimulate with mental imagery.

35. The apparatus of claim 20 wherein different threshold values are used for each of both genders.

36. The apparatus of claim 20 wherein different threshold values are used for each of different age groups.