Surgery – Miscellaneous – Methods
Reexamination Certificate
2001-07-13
2004-01-27
Brown, Michael A. (Department: 3764)
Surgery
Miscellaneous
Methods
Reexamination Certificate
active
06681774
ABSTRACT:
STATEMENT OF GOVERNMENT INTEREST
The invention described herein may be manufactured and used by or for the Government for governmental purposes without the payment of any royalty thereon.
BACKGROUND OF THE INVENTION
The present invention relates generally to recovery from brain disorders and more specifically to a procedure to enhance REM sleep.
Alzheimer's Disease is a progressive neurodegenerative disorder affecting 7% of the population over 65 years of age and characterized clinically by progressive loss of intellectual function. This impairment of function is caused by the presence of neuritic plaques in the neocortex and the loss of presynaptic markers of cholinergic neurons. Neuritic plaques are composed of degenerative axons and nerve terminals, often surrounding an amyloid core and usually containing reactive glial elements. Another characteristic pathologic feature of Alzheimer's Disease is the neurofibrillary tangle, which is an intraneuronal mass which corresponds to an accumulation of abnormally phosphorylated tau protein polymerized into fibrillar structures termed paired helical filaments. In addition, the neurofibrillary tangle also contains highly phosphorylated neurofilament proteins. Even the earliest papers on Alzheimer's Disease were clear that both “senile” plaques and neurofibrillary tangles had to be present in abundance to allow a post-mortem diagnosis of the disease.
Many treatments for recovery from brain disorders center around the presumption of chemical agents. An example of this approach is described in U.S. Pat. No. 6,228,878, May 8, 2001, Methods for treating or preventing Alzheimer's disease using substituted 2-aryl-3-morpholinopropanones, DeBernardis, John, the disclosure of which is incorporated herein by reference. An alternative to prescriptive chemical agents is using procedures to enhance REM sleep, as described below.
This process is based on observations published by E. M. Dewan in “Nature”, Volume 223, No. 5202, pp. 183-184 in 1969 that a brain damaged patient who is improving has a higher amount of REM sleep than one who is not improving as well.
SUMMARY OF THE INVENTION
The present invention is a process to prevent Alzheimer's disease and enhance recovery from brain damage afflictions. This process is made up of steps to maximize REM sleep as discussed below.
DESCRIPTION OF THE DRAWINGS
This patent contains no drawings.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Since the discovery of particular physiological changes associated with dreaming, it has often been suggested that dreaming or rapid eye movement (REM) sleep is a form of information processing. Some of these proposals have used computer analogies, others have been deduced from the kinds of perceptual events that occur in dreams, and some are derived from the nature of the mental changes, which follow dream deprivation. Some of the models suggest that REM sleep serves to discard extraneous information. Another possibility is that any long term functional reorganization in the brain must be done with the help of REM sleep; that is to say, REM sleep is necessary for adding new information to existing stores or structures—in other words, a kind of programming of the brain occurs during REM sleep.
This hypothesis predicts that a brain damaged patient who is improving will have a higher percentage of REM sleep than one who is not. The improvement we studied is that occurring over a period of weeks and months, so it cannot be attributed to the return of function of temporarily damaged, but not destroyed brain tissue. Improvement was therefore to be considered as new learning or programming. Patients suffering from aphasia as the result of a discrete cerebrovascular accident or trauma are suitable for this work. The increase in their speech production or comprehension can be determined quite easily. We assume that in patients who are learning to produce or understand new words, information is being added to the nervous system; this should be reflected by higher levels of REM sleep than in patients who show no improvement.
Eighteen aphasic patients were selected by the staff of the Neurology Service of the Boston V.A. Hospital. The patients varied in their rate of improvement and the severity of the aphasia, but this information was withheld from us until we had completed our studies of their sleep. We studied the patients with all-night electroencephalograph (EEG), electro-oculogram (EOG) and electromyogram (EMG) recording. All but four of the patients were studied at least two nights. The records were scored for REM sleep with the usual criteria of a low voltage mixed frequency EEG with REM and a decrease in muscle tone following a period of slow wave or spindle sleep. The patients were not receiving medication during the study.
TABLE 1
A COMPARISON OF PERCENTAGE REM SLEEP IN IMPROVING
AND NON-IMPROVING APHASIC PATIENTS
Subjects with no improvement
Subjects with clear improvement
Percentage
Percentage
Sub-
REM
REM (min)
Sub-
REM
REM (min)
ject
Sleep
TST (min)
ject
Sleep
TST (min)
1
4
9/212
1
23, 27
48/211,
114/420
2
12
22/181
2
23, 26
106/461,
94/368
3
20.15
62/315,
3
16, 11
66/108,
54/373
40/355
4
12.6
48/388,
4
25, 18
90/348,
20/305
67/380
5
25.18
59/239, 5
19
67/353
49/274
6
15
64/411
6
16, 17
59/362,
47/271
7
16.7
52/327,
22/338
8
13.6
47/350,
17/286
9
10.11
30/308,
28/252
N = 15
N = 11
nights
nights
Average
127
39/310
201
73/538
Significance of difference average: t test: t = 3.48-0.005 < P <0.001.
Mann-Whitney: U = 28 0.005 < P < 0.001.
TABLE 2
A COMPARISON OF PERCENTAGE REM SLEEP IN THE
MOST SEVERE AND LEAST SEVERE GROUPS (ON A
SCALE OF 0-3) (SIZE AND RATE OF
IMPROVEMENT ALSO SHOWN FOR COMPARISON)
Severe (2+ or 3)
Less severe (0-1 or 2)
Percentage
Percentage
REM
REM
Subject
sleep
Imp.
Size*
Subject
sleep
Imp.
Size
1
4
−
2 3
1
16, 11
+
1
2
12
−
2
2
25, 18
+
1
3
20, 15
−
4
3
19
+
1-2
4
12, 6
−
2
4
25, 18
−
3-4
5
15
−
3
5
16, 7
−
4
6
13, 6
−
2 3
7
10, 11
−
3 1
8
23
+
5
9
16, 17
+
2 3
N = 11 nights
N = 9 nights
Average 129 percent
172 percent
Mann Whitney U test. U − 31 0.1 > P > 0.05.
*Size estimated by brain scan on scale of 1-5 with 1 the smallest.
The clinical severity of the patients' aphasia and their rate of improvement at the time of the sleep studies were rated by the two speech therapists and the head of the Aphasia Unit. Both severity and improvement were rated on scales of 0-3. On the improvement scale—3 was dramatic, 2 clearly perceptible each week, 1 barely perceptible and 0 was for no detectable improvement. For severity—0 was for barely perceptible aphasia and 3 for total aphasia or almost so. The ratings were based on the patients' clinical progress and performance in regular speech therapy sessions. Data were also available from brain scans about the size of lesion in some patients. When rated by improvement, those with least improvement were compared with those with most improvement. Three patients with slight improvement, where there was no clear agreement among the neurology staff, were eliminated. When the percentage of REM sleep of these groups was compared there was a significant difference. Table 1 shows that non-improving patients averaged 12.7 percent REM sleep while improving patients showed 20.1 percent. The differences were significant at the 0.005 level with both the t test and the Mann-Whitney U statistic. While three of the four patients who had only one night in the laboratory were in the non-improving group, it is interesting to note that the non-improving group showed a lower percentage of REM sleep the second night than the first, so that the single nights could not have artificially lowered this group's results because of a “first night” effect. When the effect of severity on levels of REM sleep were examined, a similar difference (0.1>l′>0.05), although not as striking, was noted (Table
Auton William G.
Brown Michael A.
The United States of America as represented by the Secretary of
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