Method for determining attention deficit hyperactivity disorder (ADHD) medication dosage and for monitoring the effects of (ADHD) medication

• US 6,743,182 B2
• Filed: 11/21/2002
• Issued: 06/01/2004
• Est. Priority Date: 05/25/2001
• Status: Expired due to Fees

• Current Assignee: Mclean Hospital (Mass General Brigham, Inc.)
• Original Assignee: Mclean Hospital (Mass General Brigham, Inc.)
• Inventors: Patton, David L., Miller, Paige, Blazey, Richard N.
• Primary Examiner(s): Hoang, Tu Ba
• Application Number:
  US10/301,401
• Publication Number:
  US 20030100844A1
• Time in Patent Office: 558 Days
• Field of Search: 600/300, 600/301, 600/509, 600/536, 600/544, 600/549, 600/545, 600/558, 600/546, 600/26-28, 600/483, 600/484, 128/898, 128/897, 128/905, 128/920, 434/236, 434/238
• US Class Current: 600/549
• CPC Class Codes: A61B 3/113 for determining or recording eye movement
• 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 5/01 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
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof

Abstract

A method for determining the appropriate dosage of a medication to treat Attention Deficit Hyperactivity Disorder (ADHD) in an individual who has ADHD comprising: sampling the peripheral skin temperature of a human subject during a predetermined time interval when the subject is in an inactive state to provide sampled peripheral skin temperature data; analyzing the sampled peripheral skin temperature data for a pre-selected parameter to determine whether the pre-selected parameter has a value indicative of ADHD; and determining the proper dosage of a medication to treat ADHD based upon the determined value of the pre-selected parameter. At a time subsequent to administering the dosage, it is determined if a previously administered dosage of a medication is effective at removing the effects of ADHD as measured by this pre-selected parameter.

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:

measuring the stress of a human subject by sampling the peripheral skin temperature of a human subject during a predetermined time interval when the subject is in an inactive state to provide sampled peripheral skin temperature data;

analyzing the sampled peripheral skin temperature data for a pre-selected parameter to determine whether said pre-selected parameter has a value indicative of ADHD; and

determining the proper dosage of a medication to treat ADHD based upon said determined value of said pre-selected parameter; and

at a time subsequent to administering said dosage, determining if the administered dosage of medication is actually effective at removing the effects of ADHD as measured by said pre-selected parameter.

2. The method of claim 1 wherein said analyzing includes:

dividing the sampled data into windows of subsets of data;

processing the subset data for each window with a Fast Fourier Transform (FFT) algorithm to produce FFT data having magnitude values;

calculating a magnitude range value for each window; and

aggregating the magnitude range values to produce an aggregate value; and

comparing the produced value with a previously determined threshold value to determine said proper dosage.

3. The method of claim 1 including an earphone 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.

4. The method of claim 3 including a source of white noise coupled to said earphone to provide white noise during said predetermined time interval.

5. The method of claim 1 including glasses or goggles 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.

6. The method of claim 2 wherein demographic information including gender, age and weight of the human subject are used to be determined said proper dosage.

7. The method of claim 2 wherein said threshold value is chosen so that determined values above said threshold value indicate normalcy and determined values below said threshold value indicate ADHD and wherein said dosage is increased as a function of how great is the difference between said produced value and said threshold value.

8. The method of claim 1 including administering said determined dosage of said human subject;

after waiting a period of time for the medication to take effect, repeating said sampling and analyzing to produce a new value of said pre-selected parameter, and based on said new value, (a) maintaining said dosage if said new value is indicative of ADHD, or (b) increasing said dosage if said new value is indicative of ADHD.

9. The method of claim 8 wherein said period of time is a function of the medication'"'"'s half-life in said human subject'"'"'s body.

10. The method of claim 2 including administering said dosage of said medication to said human subject, after waiting a period of time for the medication to take effect, repeating said dividing, processing, calculating and aggregating to produce a new aggregate value, and based on said new aggregate value, (a) maintaining said dosage if said new aggregate value when compared to said previously determined threshold value is not indicative of ADHD, or (b) increasing said dosage if said new aggregate value when compared to said previously determined threshold value is indicative of ADHD.

11. The method of claim 10 wherein said period of time is a function of the medication'"'"'s half-life in said human subject'"'"'s body.

12. The method of claim 1 further comprising the step of measuring stress using a technique selected from;

bilateral temperature variability, heart rate variability, muscle tension, bilateral muscle tension imbalance, galvanic skin response eye saccades, blood oxygen, salivary IGA, electroencephalography peripheral blood flow and peripheral blood flow variability (PPG).

13. The method of claim 1 wherein in said testing the peripheral skin temperature of at least one hand of each individual is sampled.

14. The method of claim 1 wherein in said testing, the peripheral temperature of the dominant hand of each individual is tested.

15. The method of claim 13 wherein the peripheral skin temperature of both hands of each individual is sampled and said parameter value for that individual is produced by analyzing the sampled peripheral skin data from both said hands.

16. The method of claim 1 wherein said method uses one or more of the following for aggregation;

including the standard deviation, range, interquartile distance, skewness, kurtosis, Winsorized means, Winsorized variance, robust estimates of mean, and robust estimates of variance.

17. The method of claim 2 wherein said process uses one or more of the following for aggregation;

include using the data from only one hand—

either the left hand, the right hand or the dominant hand.

18. The method of claim 1 wherein said pre-selected parameter is calculated from a Fourier Transform, of said skin temperature data.

19. The method of claim 1 wherein said pre-selected parameter is calculated from a Wavelet Transform of said skin temperature data.