Surgery – Diagnostic testing – Cardiovascular
Reexamination Certificate
2000-01-27
2001-06-12
Lacyk, John P. (Department: 3736)
Surgery
Diagnostic testing
Cardiovascular
C600S509000, C607S045000, C128S898000
Reexamination Certificate
active
06245021
ABSTRACT:
BACKGROUND
The present invention relates to a method for diagnosing psychiatric disorders by monitoring the pattern of a subject's heart rate, and more particularly to a method for diagnosing psychiatric disorders by monitoring at least a portion of a subject's circadian heart rate pattern. The present invention also provides a method for assessing the effectiveness of treatments for psychiatric disorders.
Despite intensive research for nearly a century, there is still no reliable ‘laboratory test’ for mental illness. Diagnoses are still made ‘clinically’, on the basis of subjective experience [symptoms] and observed behaviour [signs]. Given the difficulties of defining normal experience and behaviour and the lack of any reliable objective indicators, it is not surprising that to date, all systems of diagnosis/classification in psychiatry have been less than satisfactory for one reason or another. A reliable laboratory test would be of enormous practical value in everyday clinical practice and contribute greatly to advancement in theory and practice more generally.
It is suggested that hitherto attempts to find ‘laboratory indicators’ of mental illness have failed because of their conceptually misguided approach. Previous researchers have tended to look for some ‘fixed’ chemical/anatomical lesion in the brain, in imitation of a neurological or neuropathological approach. If, however, there is no such ‘fixed’ lesion, but rather a functional disregulation, [like a ‘tuning problem’ in a car and TV set], then the neuropathological approach is doomed to failure.
The present invention seeks to provide a method for diagnosing psychiatric disorders or to at least provide a diagnostic method that may provide objective indications of clinical status and change and contribute to the diagnostic assessment of a subject.
SUMMARY OF THE INVENTION
The present invention provides a method for diagnosing a psychiatric disorder in a subject, the method comprising the steps of: measuring the subject's heart rate pattern and; using said pattern to diagnose the psychiatric disorder.
The present invention is based on the identification of a psychophysiological correlation between heart rate and psychiatric status. In this respect, it has been found that certain clinical states are consistently associated with distinctly different heart rate patterns.
The heart rate pattern may be measured over a variety of time periods. Thus, in one form the heart rate pattern is a circadian heart rate pattern, in that it is measured over a 24 hour period. Whilst the entire circadian heart rate pattern may be used in the method of the present invention, certain portions of the circadian heart rate pattern may also be used to diagnose psychiatric disorders. In this respect, psychiatric disorders may be identified and diagnosed from analysis of characteristic patterns within portions of the circadian heart rate pattern.
Thus, the present invention also provides a method for diagnosing a psychiatric disorder in a subject, the method comprising the steps of: measuring at least a portion of the subject's circadian heart rate pattern and; using said pattern or portion thereof to diagnose the psychiatric disorder.
When the method comprises the measurement a portion of the circadian heart rate pattern the portion measured may be varied provided the portion is capable of exhibiting a pattern that correlates to a psychiatric disorder. In one particular form, the heart rate pattern is measured over a period of at least approximately 90 minutes.
The heart rate pattern of a subject whilst asleep and during the transition from being awake to asleep and asleep to awake may be particularly useful in the method of the present invention. Thus, when the method comprises the measurement a portion of the circadian heart rate pattern, the portion of the circadian heart rate pattern is preferably the sleep portion and in particular the sleep portion including the transition of the subject into and out of sleep.
The heart rate pattern may be measured in a variety of formats. Preferably, the heart rate pattern is measured as beats per minute over time. Alternatively, the heart rate pattern may be measured as a difference plot which reflects variations or fluctuations in heart rate. When the heart rate pattern is a difference plot, the difference plot is preferably a plot of [heart rate (t+1)−heart rate (t)], where t is time in minutes, over time.
Of course, the heart rate pattern of a subject may be measured in a plurality of formats and the plurality of formats may be used together to diagnose psychiatric disorders according to the method of the present invention. Thus, the present invention also provides a method for diagnosing a psychiatric disorder in a subject, the method comprising the steps of: measuring the subject's heart rate pattern in a plurality of formats, such as beats per minute over time and [heart rate (t+1)−heart rate (t)], where t is time in minutes, over time and; diagnosing the psychiatric disorder.
The method of the present invention may be computerised. In this respect, a subject's heart rate pattern may be measured and recorded in a form that allows it to be cross-checked with a database of reference heart rate patterns indicative of psychiatric disorders.
Thus, the present invention also provides a method for diagnosing a psychiatric disorder in a subject, the method comprising the steps of: measuring the heart rate pattern of the subject and; comparing said pattern with at least one reference heart rate pattern indicative of a psychiatric disorder wherein the reference heart pattern is provided in a computerised database.
The subjects heart rate pattern may be measured in a variety of ways. Preferably, the subjects heart rate is measured with a monitor that is unobtrusive and leaves the person freely ambulant.
When the method of the present invention involves the use of reference heart rate patterns, the reference heart rate patterns may be varied and preferably are developed by collecting data from a sufficient number of patients with psychiatric disorders to determine a typical pattern.
When the biophysical parameter is a circadian heart rate pattern, the reference heart rate pattern may be selected from those illustrated in the examples and in particular those patterns illustrated in
FIGS. 1
to
4
.
The present invention may be used to diagnose a variety of psychiatric disorders. For example, the method of the present invention may be used to diagnose a psychiatric disorder selected from the group comprising; General Anxiety Disorder (GAD), Panic Disorder (PD), Obsessive-Compulsive Disorder (OCD), non-psychotic Major Depression, Somatoform Disorder (hypochondriacal type), Delusional Disorder (paranoid and somatic type) Attention Deficit Disorder (ADD) and acute Schizophreniform Disorder.
Heart rate patterns may be affected by a range of factors. Some factors may produce noise that may hamper the interpretation of the heart rate pattern, which is clearly undesirable. To assist in accounting for and thus negating the effects of noise, the method of the present invention may further comprise the recordal of a subject's activities throughout the time the subject is being subjected to the method.
Thus, the present invention provides a method for the diagnosis of a psychiatric disorder in a subject, the method comprising the steps of: measuring the subject's heart rate pattern; comparing the subject's heart rate pattern with a record of the subject's activities and; comparing said pattern with at least one reference heart rate pattern indicative of a psychiatric disorder wherein the comparison of the subject's heart rate pattern with the record of the subjects activities allows for the effects of noise in the subject's heart rate pattern to be negated.
Preferably, the record of the subject's activities comprises a daily diary that is completed by the subject when being subjected t
Carter Ryan
HeartLink NA Patent Corporation
Kohn & Associates
Lacyk John P.
LandOfFree
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