Surgery – Miscellaneous – Methods
Reexamination Certificate
1999-02-18
2001-06-19
Nguyen, Dinh X. (Department: 3738)
Surgery
Miscellaneous
Methods
Reexamination Certificate
active
06247473
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to a system and method for testing neurological treatments, and particularly to the testing of neuroprotective and neuroregenerative effects of various drugs on humans.
BACKGROUND OF THE INVENTION
There has been substantial research in the area of preventing or repairing damage to the central nervous system. Certain drugs, such as brimonidine and various beta-adrenergic blocking agents, have been accepted as neuroprotective drugs that can protect the central nervous system from acute ischemia and crush trauma in humans. Evidence now shows that at least some of the drugs can stabilize, reinforce or even regenerate neurotubules within central or peripheral neurons of a human nervous system to prevent or regenerate damage caused by, for instance, direct crush injury.
Research and testing of such neuroprotective and/or neuroregenerative drugs can be problematic due to the difficulty in performing actual tests prospectively on human subjects. Traditionally, research has been done on animals, but this has limited the ability of scientists to develop new drugs, because results in animals do not always correlate with results in humans.
The ability to test neuroprotective or neuroregenerative drugs on humans would provide researchers with an additional tool that would accelerate the development of drugs for a wide variety of neurological problems. For example, research is being done and there is hope for drugs that will protect and repair nerves damaged in, for example, compression fractures of the spine. The ability to test such drugs on human subjects would also aid in the research into drugs that could negate the neurological damage due to strokes or neuralapostosis in which nerves send self-destruct signals subsequent to being damaged. There is a great need for drugs which are able to slow or stop such neurological damage.
It would be advantageous to determine a common procedure or occurrence that produces readily measurable but clinically insignificant damage to the human central nervous system to facilitate testing of such drugs or other treatments.
SUMMARY OF THE INVENTION
The present invention features a method for testing the neuroprotective or neuroregenerative effects of a substance on a human central nervous system without clinically significant damage to neural tissue. The method includes creating a vacuum on an external surface of an eye of a human. The method further includes measuring the extent of loss to central nervous tissue of the eye due to the vacuum.
Either before and/or after creation of the vacuum, the human is treated with a test substance. After a predetermined period, loss of central nervous tissue due to the vacuum is measured to determine the effect of the test substance. The results are then compared to a control.
According to another aspect of the invention, a method is provided for testing neuroprotective or neuroregenerative effects of a treatment on nerve tissue of a human. The method includes causing measurable but clinically insignificant damage to nerve tissue of a human and treating the human. The treatment can either be before and/or after the creation of the clinically insignificant nerve tissue damage. Subsequently, the depletion of nerve tissue is measured after a designated period following creation of the clinically insignificant nerve tissue damage and the treatment.
According to another aspect of the invention, a method is provided for testing neuroregenerative or neuroprotective effects on a human central nervous system. The method includes producing measurable but clinically insignificant damage to a human central nervous system in a statistically significant number of human subjects. The method also includes producing measurable but clinically insignificant damage to a control human central nervous system in a statistically significant number of human control subjects. The method also includes treating the statistically significant number of human subjects with a test substance, and comparing human central nervous system damage in the statistically significant number of human subjects with the statistically significant number of human control subjects. By this method, the neuroprotective or neuroregenerative effects of the test substance may be determined.
REFERENCES:
patent: 5523301 (1996-06-01), Amon et al.
patent: 5856329 (1999-01-01), Wheeler et al.
Robert David, “Changing therapeutic paradigms in glaucoma management” 1998 Ashley Publications Ltd. ISSN 1354-3784; pp. 1063, 1074-1076.
Fletcher Yoder & Van Someren
Nguyen Dinh X.
Third Millenium Trust
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