Surgery – Diagnostic testing – Temperature detection
Reexamination Certificate
2001-05-25
2003-02-18
Hoang, Tu Ba (Department: 3742)
Surgery
Diagnostic testing
Temperature detection
C600S300000, C600S483000
Reexamination Certificate
active
06520921
ABSTRACT:
FIELD OF THE INVENTION
This invention relates in general to a technique for monitoring the effectiveness of medication taken to treat Attention Deficit Hyperactivity Disorder (ADHD) and more particularly to a technique for measuring an individual's peripheral temperature variability (TV) indicative 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 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 under achievement, 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 involves a process of elimination using written and verbal assessment insttuments. 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.
11. U.S. Pat. No. 5,377,100, issued Dec. 27, 1994, inventors Patton et al., discloses a system and of managing the psychological state of an individual using images.
12. U.S. Pat. 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 discussed 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 practitioner 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 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 and fulfillment of the needs 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:
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.
ADVANTAGEOUS EFFECT OF THE INVENTION
The invention has the following advantages.
1. A device and technique for determining the effectiveness of the medication and appropriate dosage taken to counteract ADHD by an individual whom has ADHD which is simple, inexpensive and reliable.
REFERENCES:
patent: 4456347 (1984-06-01), Stahly
patent: 5199439 (1993-04-01), Zimmerman et al.
patent: 5377100 (1994-12-01), Pope et al.
patent: 5630664 (1997-05-01), Farrelly
patent: 5720773 (1998-02-01), Lopez-Claros
patent: 5913310 (1999-06-01), Brown
patent: 5918603 (1999-07-01), Brown
patent: 5940801 (1999-08-01), Brown
patent: 6053739 (2000-04-01), Stewart et al.
patent: 6097980 (2000-08-01), Monastra et al.
patent: 6117075 (2000-09-01), Barnea
patent: 6325763 (2001-12-01), Pfeiffer et al.
patent: 6375622 (2002-04-01), Kao et al.
Disclosure on the Development of EEG Diagnostics and Biofeedback for Attention-Deficit/Hyperactivity Disorders, Joel F. Lubar, Biofeedback and Self-Regulation, vol. 6, No. 3, 191.
Functional Deficits in Basal Ganglia of Children with Attention-Deficit/Hyperactivity Disorder Shown with Functional Magnetic Resonance Imaging Relaxometry, Teichler et al., Nature Magazine, Apr. 2000, vol. 6, No. 4, pp 470-473.
Human Factors and Cognitive/Perceptual Information Processing, A virtuality Reality Environment for the Assessment of Attention Deficit Disorders in Children, Rizzo et al., Human Factors and Cognitive/Perceptual Information Processing, University of Southern California, Jul. 1999.
Clinical Practice Guideline: Diagnosis and Evaluation of the Child wit
Blazey Richard N.
Miller Paige
Patton David L.
Eastman Kodak Company
Hoang Tu Ba
Noval William F.
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