Surgery – Diagnostic testing
Reexamination Certificate
2002-03-06
2004-04-27
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
C600S549000
Reexamination Certificate
active
06726624
ABSTRACT:
FIELD OF THE INVENTION
This invention relates in general to technique for monitoring the effectiveness of medication taken to treat Attention Deficit Hyperactivity Disorder (ADHD) and more particularly to a technique and apparatus for measuring and objectively analyzing an individual's peripheral temperature variability to determine values indicative of the level of manifestation of ADHD.
BACKGROUND OF THE INVENTION
ADHD is the most common neurobehavioral disorder of childhood as well as among the most prevalent health conditions affecting school-aged children. Between 4% and 12% of school age children (several millions) are affected. $3 billion is spent annually on behalf of students with ADHD. Moreover, in the general population, 9.2% of males and 2.9% of females are found to have behavior consistent with ADHD. Upwards of 10 million adults may be affected.
ADHD is presently a difficult disorder to diagnose. The core symptoms of ADHD in children include inattention, hyperactivity, and impulsivity. ADHD children may experience significant functional problems, such as school difficulties, academic underachievement, poor relationships with family and peers, and low self-esteem. Adults with ADHD often have a history of losing jobs, impulsive actions, substance abuse, and broken marriages. ADHD often goes undiagnosed if not caught at an early age and affects many adults who may not be aware of the condition. ADHD has many look-alike causes (family situations, motivations) and co-morbid conditions (depression, anxiety, and learning disabilities) are common.
Diagnosis of ADHD currently involves a process of elimination using written and verbal assessment instruments. However, there is no one objective, independently validated test for ADHD. Various objective techniques have been proposed but have not yet attained widespread acceptance. These include:
1. The eye problem called convergence insufficiency was found to be three times more common in children with ADHD than in other children by University of California, San Diego researchers.
2. Infrared tracking to measure difficult-to-detect movements of children during attention tests combined with functional MRI imaging of the brain were used by psychiatrists at McLean Hospital in Belmont, Mass. to diagnose ADHD in a small group of children (
Nature Medicine
, Vol. 6, No. 4, April 2000, Pages 470-473).
3. Techniques based on EEG biofeedback for the diagnoses and treatment of ADHD are described by Lubar (
Biofeedback and Self
-
Regulation
, Vol. 16, No. 3, 1991, Pages 201-225).
4. U.S. Pat. No. 6,097,980, issued Aug. 1, 2000, inventor Monastra et al, discloses a quantitative electroencephalographic process assessing ADHD.
5. U.S. Pat. No. 5,913,310, issued Jun. 22, 1999,inventor Brown, discloses a video game for the diagnosis and treatment of ADHD.
6. U.S. Pat. No. 5,918,603, issued Jul. 6, 1999, inventor Brown, discloses a video game for the diagnosis and treatment of ADHD.
7. U.S. Pat. No. 5,940,801, issued Aug. 17, 1999, inventor Brown, discloses a microprocessor such as a video game for the diagnosis and treatment of ADHD.
8. U.S. Pat. No. 5,377,100, issued Dec. 27, 1994, inventors Pope et al., discloses a method of using a video game coupled with brain wave detection to treat patients with ADHD.
9. Dr. Albert Rizzo of the Integrated Media Systems Center of the University of Southern California has used Virtual Reality techniques for the detection and treatment of ADHD.
10. U.S. Pat. No. 6,053,739, inventors Stewart et al., discloses a method of using a visual display, colored visual word targets and colored visual response targets to administer an attention performance test.
U.S. Pat. No. 5,377,100, issued Dec. 27, 1994, inventors Patton et al., discloses a system and for managing the psychological state of an individual using images.
U.S. Pat. No. 6,117,075 Barnea discloses a method of measuring the depth of anesthesia by detecting the suppression of peripheral temperature variability.
There are several clinical biofeedback and physiologic monitoring systems (e.g. Multi Trace, Bio Integrator). These systems are used by professional clinicians. Although skin temperature spectral characteristics have been shown to indicate stress-related changes of peripheral vasomotor activity in normal subjects, there has been no disclosure of use of variations in skin-temperature response to assist in diagnosing ADHD. (See: Biofeedback and Self-Regulation, Vol. 20, No. 4, 1995).
As stated above, the primary method for diagnosing ADHD is the use of a bank of written and verbal assessment instruments designed to assess the children for behavioral indicators of criteria established by American Medical Association (AMA) as described in the Diagnostic and Statistics manual—IV (DSM-IV). Psychiatrists, psychologists, school psychologists and other licensed practitioners administer these assessment instruments. In some cases those individuals who meet DSM-IV criteria for ADHD diagnosis are prescribed a drug such as Ritalin. Behavioral observations of the patient while on Ritalin are conducted to assess the impact of prescribed medication. However, clearly established criteria for evaluating the impact of specific medications e.g., Ritalin and specific dosages are lacking. It would be advantageous for physicians to have access to clearly established physiologic criteria, which could be measured, to determine if a specific medication at a specific dosage effectively addressed the underlying physiologic parameter, which was indicative of ADHD.
There is thus a need for a simple, inexpensive, and reliable objective technique for determining the effectiveness of the medication and appropriate dosage taken to counteract ADHD by an individual who has ADHD.
SUMMARY OF THE INVENTION
According to the present invention, there is provided a solution to the problems discussed above.
According to a feature of the present invention, there is provided 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.
ADVANTAGEOUS EFFECT OF THE INVENTION
The invention has the following advantages.
1. A device and technique for objectively determining the effectiveness of the medication and appropriate dosage taken to counteract ADHD by an individual who has ADHD which is simple, inexpensive and reliable.
REFERENCES:
patent: 5377100 (1994-12-01), Pope et al.
patent: 5913310 (1999-06-
Blazey Richard N.
Keirsbilck Richard S.
Miller Paige
Parks Peter A.
Patton David L.
Clark & Elbing LLP
McErosky David J.
The McLean Hospital Corporation
Winakur Eric F.
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