Surgery – Diagnostic testing
Reexamination Certificate
2000-03-02
2002-09-24
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
C600S595000
Reexamination Certificate
active
06454706
ABSTRACT:
A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of any portion of the patent document, as it appears in any patent granted from the present application or in the Patent and Trademark Office file or records available to the public, but otherwise reserves all copyright rights whatsoever.
A microfiche appendix containing source code utilized in practicing an exemplary embodiment of the invention is included as part of the Specification and is hereinafter referred to as Appendix A. Appendix A includes a total of 2 microfiche and a total of 151 frames.
FIELD OF THE INVENTION
This invention relates in general to the field of neurology and neurological testing. More particularly, the present invention relates to the objective clinical assessment of motor function by computer analysis of a digitized writing sample, as may be used in the diagnosis and monitoring of motor disorders as well as the evaluation of motor development and handedness in children.
BACKGROUND OF THE INVENTION
A patient may seek medical treatment for a variety of complaints which suggest a disturbance of motor function, such as weakness, stiffness, tremor, clumsiness, or difficulty in executing movements. It then is the physician's responsibility to correctly diagnose the patient, and to implement the appropriate course of treatment. A number of syndromes which involve motor dysfunction exist, and are defined by their clinical manifestations.
For example, Parkinson's Disease, which results from a degeneration of cells in the basal ganglia of the brain, is associated with slowness of movement (“bradykinesia”), muscle rigidity, and a tremor often said to have a “pill rolling” quality which occurs at rest but tends to diminish with voluntary movements. In addition, patients suffering from Parkinson's Disease may exhibit a loss of facial expression, a difficulty in initiating movements, and a diminution of their handwriting (“micrographia”).
Another fairly common motor disorder is essential tremor, an inherited condition which can present in childhood but more typically appears later in adult life. It usually involves the upper limbs, but may also affect the head, jaw, lips, tongue and pharynx. This tremor may abate upon ingestion of alcohol or beta-adrenergic antagonists. It may interfere with voluntary movements to the point where a sufferer is unable to drink from a glass or raise a spoon without spilling its contents.
There are numerous other motor disorders from hyperkinetic conditions such as essential tremor mentioned above to complex akinetic-rigid and other degenerative syndromes. Motor disorders may be considered primary when there are no known causes (other than genetics) and secondary, or symptomatic, when a known etiologic agent exists. Examples of primary motor disorders include Parkinson's disease, essential tremor and adult onset focal dystonia such as writer's cramp. Secondary motor disorders are more numerous and include Parkinsonian syndromes, side effects of medications such as tardive dyskinesia from neuroleptic use, immune, ischemic or even traumatic causes.
The multitude of motor disorders share many overlapping symptoms and signs. Even though sophisticated rating systems have been developed for some disorders (e.g., Parkinson's Disease) to aid in the accuracy of diagnosis, in the hands of inexperienced practitioners, or where the disease is in its early stages and clinical signs are subtle, the potential for an erroneous diagnosis is substantial. Diagnosis by a traditional neurologic exam may also be difficult where the patient is unable to comply with fairly detailed instructions for tests used to evaluate motor function. As an example, a young child or a demented adult suspected of having a defect in motor development may be difficult to evaluate.
If an error in diagnosis is made, there may be significant adverse consequences. For example, the appropriate therapies for Parkinson's Disease and essential tremor are very different, in that patients with Parkinson's Disease are treated with agents that increase or facilitate dopamine activity whereas patients with essential tremor are treated with agents that block beta-adrenergic neurotransmitters. Not only would misdiagnosis result in a lack of a clinical benefit, but administering the inappropriate drug could have undesirable or even toxic side effects.
For example, beta adrenergenic blocking agents can adversely affect cardiac or pulmonary functions; unnecessary use in a Parkinson's Disease patient, particularly an older patient, could be dangerous. Similarly, use of agents that treat Parkinson's disease in a patient without that condition could have harmful consequences. Specific examples of Parkinson's Disease treating agents include artane, sinemet and baclofen. Artane, an anticholinergic agent used to treat Parkinsonian tremors and dystonia can severely affect cognition, cardiac, visual and urinary function. Sinemet, a mainstay drug for Parkinson's disease, causes nausea, vomiting, hallucinations and low blood pressure. Baclofen, an anti-spasmodic agent, and clonazepam, an anxiolytic and muscle relaxant, are used in many motor disorders but can alter mental status, blood pressure and can even be fatal when used inappropriately.
Further, even where the correct diagnosis has been made, it is important to be able to evaluate the clinical progress of a patient. Often the methods for measuring progress are extremely subjective.
One means by which clinicians have attempted to decrease subjectivity in diagnosis and monitoring motor function has been through the use of standardized clinical tests. Examples of such tests include asking the patient to touch his finger to, alternately, his nose and the outstretched finger of the examiner, or to run her heel up and down her shin, or to touch his or her thumb to, in succession, each of the other fingertips of the same hand.
Drawing has been used to evaluate motor function for many years. The famous neuropsychiatrist Kraepelin, at the beginning of this century, adapted an instrument to quantitatively analyze signatures for the evaluation of motor function in schizophrenic patients (Blyler et al., 1997, Schizophrenia Res. 26: 15-23, citing Hoch, 1904, Psychol. Bull. 1:241-257). One common test involves asking the patient to draw an Archimedes spiral. A thorough discussion of the spiral drawing test may be found in Bain & Findley, in “Standards in Neurology, Series A: Assessment, diagnosis and evaluation, Book I: Assessing Tremor Severity,” published by Smith Gordon and Co., Ltd., London, England/Nishimura Co., Ltd., Niigata-Shi, Japan, copies of which can be obtained in the United States through Books International Inc., Herndon, Virginia. According to that reference, the severity of tremor apparent in the spiral is rated from 0-10, where critical factors in determining the grade of a particular spiral are the degree of perpendicular displacement of the track from the intended trajectory and the extent to which tremor persists during each turn (Bain & Findley, p.9). Tremor is said to become more apparent in the outward turns of the spiral. An example of a study which used spiral analysis to quantify the effects of the drug terguride in Parkinson's Disease patients is reported in Filipova et al., 1988, Eur. Arch. Psychiatr. Neurol. Sci.237:298-303. Another study which used spiral copying ability to evaluate the effect of the drug ondasetron on cerebellar tremor is described in Rice et al., 1997, J. Neurol. Neurosur. & Psychiat. 62:282-284.
A number of investigators have attempted to lessen the subjectivity of evaluation by using computer assistance. For example, Elble et al. (1996, Movement Disorders 11:70-78) asked patients with essential tremor to write a series of cursive e's and l's and, in some cases, to draw an Archimedes spiral on a digitizing tablet. They reported detecting changes i
McCrosky David
The Trustees of Columbia University in the City of New York
Winakur Eric F.
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