1111111111111111 IIIIII IIIII 1111111111 11111 111111111111111 IIIII IIIII 111111111111111 11111111
`US 20100331603Al
`
`c19) United States
`c12) Patent Application Publication
`Szecsi
`
`c10) Pub. No.: US 2010/0331603 Al
`Dec. 30, 2010
`(43) Pub. Date:
`
`(54) METHOD AND DEVICE FOR THE PHYSICAL
`TREATMENT OF PARETIC PATIENTS
`
`(76)
`
`Inventor:
`
`Johann Szecsi, Petershausen (DE)
`
`Correspondence Address:
`K&L Gates LLP
`P.O. Box 1135
`CHICAGO, IL 60690 (US)
`
`(21) Appl. No.:
`
`12/726,689
`
`(22) Filed:
`
`Mar. 18, 2010
`
`Related U.S. Application Data
`
`(60) Provisional application No. 61/161,278, filed on Mar.
`18, 2009.
`
`Publication Classification
`
`(51)
`
`Int. Cl.
`A61N 2102
`(2006.01)
`A61N 2100
`(2006.01)
`A63B 22106
`(2006.01)
`(52) U.S. Cl. .................................. 600/13; 600/9; 482/57
`ABSTRACT
`(57)
`
`The present invention relates to a training device for the
`physical therapy of paretic patients, comprising at least one
`magnetic stimulator for applying functional magnetic stimu(cid:173)
`lation to paralyzed muscles of said patient in order to induce
`a periodical movement; at least one guiding element for
`restricting the degrees of freedom of the movement induced;
`and at least one resistance element for providing a resistance
`against the movement induced, wherein the device is config(cid:173)
`ured such that the torque of the movement induced is at least
`1.25 Nm. The invention also concerns a therapy method for a
`paretic patient, comprising providing such a training device,
`applying magnetic stimulation, impeding the movement via
`the at least one resistance element; and determining the
`torque of the movement induced.
`
`\/z}/• ..
`/.·'··-.. i-·-, -. ___ \ ..
`wo;----·71·~ !r
`
`·,_
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`Patent Application Publication Dec. 30, 2010 Sheet 1 of 13
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`US 2010/0331603 Al
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`Patent Application Publication Dec. 30, 2010 Sheet 2 of 13
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`US 2010/0331603 Al
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`FIGURE 2
`
`25.---------------.-----.-------r-----,-,
`
`- - -
`
`20
`......
`E; 15
`~
`Q)
`::,
`e-10
`~
`c:: 5
`~
`(.)
`
`~
`
`o~~~/.J,~
`FES
`
`0
`
`I
`
`50
`
`~
`
`~
`
`FMS
`
`150
`
`200
`
`FMS+FES
`
`I
`
`100
`Time [s]
`
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`Patent Application Publication Dec. 30, 2010 Sheet 3 of 13
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`US 2010/0331603 Al
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`FIGURE 3
`
`15
`E
`b10
`(I)
`::J e-
`0
`~5
`c::
`e!
`(.)
`
`FMS
`
`FES+FMS
`
`0
`
`50
`
`100
`Time [s]
`
`150
`
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`Patent Application Publication Dec. 30, 2010 Sheet 4 of 13
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`US 2010/0331603 Al
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`FIGURE 4
`
`o~-~--~-~--~-~--~--
`o
`100
`150
`200
`250
`300
`350
`50
`Crank Angle[°]
`-25~--~--~------r-----,.---.-----......------,--,
`E
`z20
`......
`
`♦
`
`+ ••
`
`♦ •
`,
`♦
`. . . . . ♦ ~ •
`.
`;, ♦ - -~_,......_ili'Ow~•.r'/,cl-"'"•-";,--'f....,,,.,_,_..c:'•_
`~.,,,,.,,,_..._..,.,
`. ,,.~T ...
`~ -:..
`+
`
`I
`
`200
`150
`Crank Angle[°]
`
`250
`
`300
`
`350
`
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`Patent Application Publication Dec. 30, 2010 Sheet 5 of 13
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`US 2010/0331603 Al
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`FIGURE 5
`
`0.25
`
`120 .-----,-------.-----.---------;::::::r::=====::;i0,3
`-FMS
`-FES
`c:J
`II)
`~VOL
`ID 100
`C
`.:::
`0
`0 80
`E
`
`*
`## ##
`
`Cl.I
`
`"' ~ ... 60
`~ a.
`,.:; 40
`E
`~
`4U
`::s 20
`~
`0
`I-
`
`0
`
`Torque
`
`Power
`
`Smoothness
`
`Symmetry
`
`0.2
`
`c:J
`C'
`di
`0.15 E
`E
`~
`
`0.1
`
`0.05
`
`0
`
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`Patent Application Publication
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`Dec. 30, 2010 Sheet 6 of 13
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`US 2010/0331603 Al
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`FIGURE 6
`
`30
`
`25
`.....
`E
`a;,20
`QI
`::::s e-
`~ 15
`u
`ii
`; 10
`0
`.!!!.
`
`5
`
`0
`
`1=~~~, 15
`
`12.5
`
`~
`...
`~
`a.
`
`CII
`
`10
`
`7.5
`
`5
`
`2.5
`
`0
`
`Torque
`
`Power
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`.
`. PatentA pphcation Publ.
`1cat1on
`
`Dec. 30 201
`0 Sheet 7 of 13
`'
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`US 2010/0331603 Al
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`FIGURE 7
`
`Localization
`
`.
`Magstim Torque (NORM ME
`.. ·
`·
`AN)
`
`'. '
`1 ~· : ..
`0.75
`•. · ·
`0.5!
`
`0.251 •
`();: ..
`, ..
`
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`Patent Application Publication Dec. 30, 2010 Sheet 8 of 13
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`US 2010/0331603 Al
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`FIGURE 8
`
`2.5
`
`2
`
`1.5
`
`1
`
`0.5
`
`0
`
`MAXIMAL TORQUE
`
`AUC
`
`3
`
`2.5
`
`1
`
`fES•K
`
`fES•l
`
`fMS•l
`
`fMS-S
`
`fES_K
`
`fES-L
`
`fMS-L
`
`fMS-S
`
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`Patent Application Publication Dec. 30, 2010 Sheet 9 of 13
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`US 2010/0331603 Al
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`FIGURE 9
`
`MAXIMAL TORQUE
`
`2 I
`
`1.5
`
`1
`
`0.5
`
`AUC
`
`2.5
`
`2
`
`1.5
`
`1
`
`0.5
`
`FEs-K FES.L FMS-L FNS-S
`
`FES_K FES-L FMS-1. FMS-S
`
`;, . /~j;; 0 -~
`
`I
`
`·- .
`
`tiwef"r'
`
`. ,
`
`~~ii~'
`
`'i
`
`·=, .d ~
`If" ~...
`1
`
`·• .
`
`~j
`
`FES-K
`
`FES-L
`
`FMS-L
`
`FMS-S
`
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`Patent Application Publication Dec. 30, 2010 Sheet 10 of 13
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`US 2010/0331603 Al
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`FIGURE 10
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`Patent Application Publication Dec. 30, 2010 Sheet 11 of 13
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`US 2010/0331603 Al
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`FIGURE 11
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`Patent Application Publication Dec. 30, 2010 Sheet 12 of 13
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`US 2010/0331603 Al
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`FIGURE 12
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`Patent Application Publication Dec. 30, 2010 Sheet 13 of 13
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`FIGURE 13
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`US 2010/0331603 Al
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`Dec. 30, 2010
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`1
`
`METHOD AND DEVICE FOR THE PHYSICAL
`TREATMENT OF PARETIC PATIENTS
`
`PRIORITY
`
`[0001] This application claims the benefit of U.S. Patent
`Application Ser. No. 61/161,278 filed Mar. 18, 2009, the
`disclosure of which is hereby incorporated by reference in its
`entirety.
`
`TECHNICAL FIELD OF THE INVENTION
`
`[0002] The present invention relates to a training device for
`the physical therapy of paretic patients, comprising at least
`one magnetic stimulator for applying functional magnetic
`stimulation to paretic (in particular, to incompletely para(cid:173)
`lyzed) muscles of said patient in order to induce a periodical
`movement; at least one guiding element for restricting the
`degrees of freedom of the movement induced; and at least one
`resistance element for providing a resistance against the
`movement induced, wherein the device is configured such
`that the torque of the movement induced is at least 1.25 Nm.
`The invention also concerns a therapy method for a paretic
`patient, comprising providing such a training device, apply(cid:173)
`ing magnetic stimulation, impeding the movement via the at
`least one resistance element; and determining the torque of
`the movement induced.
`
`BACKGROUND OF THE INVENTION
`
`[0003] Functional electrical stimulation (FES) is a promis(cid:173)
`ing rehabilitation technique for artificially activating muscles
`that are not under voluntary control following a spinal cord
`injury (SCI) or a cerebrovascular insult (Gorman, P. H. et al.
`(2006), in: Neural Repair and Rehabilitation. (Selzer, M. E.
`et al., Eds.), Cambridge University Press, p. 119-135). Pos(cid:173)
`sible applications of FES are to propel or support mobility
`(gait or cycling) and to make possible conditioning exercises.
`The advantage of cycling is that it can be maintained for
`reasonably long periods and the risk of fall is low.
`[0004] FES-propelled cycling in persons with complete
`spinal cord injury (SCI) is known to train the cardiovascular
`system (Glaser, R. M. (l994)Int. J. Spots Med. 15, 142-148),
`to strengthen the muscles (Mohr, T. et al. (1997) CalcifTissue
`Int. 61, 22-25), as well as to improve cycling mobility (Per(cid:173)
`kins, T. A. et al. (2002) IEEE Trans. Neural. Syst. Rehabil.
`Eng. 10, 158-164; Hunt, K. J. et al. (2004) IEEE Trans.
`Neural. Syst. Rehabil. Eng. 12, 89-101). Exemplary training
`devices employing FES have been disclosed inter alia in U.S.
`Pat. No.4,499,900 as well as in U.S. patent applications 2003/
`0109814 Al and 2005/0015118 Al, respectively.
`[0005] Mostly, FES cycling focuses on patients with com(cid:173)
`plete SCI, although the stroke population is approximately
`10-fold that of the SCI population (Kirsch, R. F. and Kilgore.
`K. L. (2004). in: Neuroprosthetics. (Horch, K. W., and
`Dhillon, G. S., Eds.), First ed. New Jersey: World Scientific.
`p. 981-1004).
`[0006]
`It is thought that electrical stimulation can also be
`used in the latter case for training purposes as well as for
`achieving ultimate functional improvement. However, FES
`appears clinically impractical in the stroke population,
`because it induces pain (Liberson, W. T. et al. (1961) Arch.
`Phys. Merl. Rehabil. 42, 101-105; Takebe, K. et al. (1975)
`Arch. Phys. Med. Rehabil. 56, 237-239) due to unavoidable
`stimulation of the skin receptors, including A-delta myeli(cid:173)
`nated heat nociceptors and C-fiber nociceptors (Adriaensen,
`
`H. et al. (1983) J. Neurophysiol. 49, 111-122; Chae, J. et al.
`(l998)Am. J. Phys. Med. Rehabil. 77, 516-522).
`[0007] For this reason, 8 of 46 subjects in a study on the
`efficacy ofFES in acute stroke patients could not tolerate FES
`treatment (Chae, J. et al. (1998) Stroke 29, 975-979). In the
`study ofYan and colleagues (Yan, T. et al. (2005) Stroke 36,
`80-85) thigh stimulation intensities of20-30 mA were used to
`achieve weight-supported knee joint movement. In two stud(cid:173)
`ies on leg stimulation-supported gait in the same group (Tong,
`R. K. et al. (2006a)Arch. Phys. Med. Rehabil. 87, 1298-1304;
`Tong, R. K. et al. (2006b) Phys. Ther. 86. 1282-1294) the
`stimulation intensity was set to 50-85 mA in an effort to
`achieve limb movement at the subject's comfort threshold.
`However, only small or sub-maximal isometric torques could
`be generated at those intensities as seen in the torque recruit(cid:173)
`ment curve of the quadriceps. It has been shown that increases
`in quadriceps femoris strength in a normal population who
`trained with FES correlated with training contraction inten(cid:173)
`sity and duration (Selkowitz, D. M. (1985) Phys. Ther. 65,
`186-196). It was concluded that the relative increase in iso(cid:173)
`metric strength resulting from training with FES might be
`determined by the ability of the subjects to tolerate longer and
`more forceful contractions. Another study also demonstrated
`that cycling power and smoothness in acute stroke patients
`are limited by the individual's ability to tolerate stimulation
`current (Szecsi, J. et al. (2008) Clin. Biomech. 23, 1086-
`1094).
`[0008]
`In contrast, by using time-varying electromagnetic
`fields to induce eddy currents in the adjacent volume without
`passing the skin, repetitive functional magnetic stimulation
`(FMS) activates the nerve innervating the muscle without
`stimulating the skin nociceptors (Barker, A. T. et al. (1987)
`Neurosurgery 20, 100-109; Barker, A. T. (1991) J. Clin. Neu(cid:173)
`rophysiol. 8, 26-37). Moreover, magnetic stimulation does
`not produce radial current, which activates pain nerves in the
`skin best (Cohen, D. and Duffin, B. N. (1991) J. Clin. Neu(cid:173)
`rophysiol. 8, 102-111).
`[0009] However, the application of FMS is hampered by
`the fact that, as compared to electrical stimulators, magnetic
`stimulators are bulkier and they cannot provide focal stimu(cid:173)
`lation (Cohen, D. and Duffin, B. N. (1991), supra). This is a
`significant drawback because human movement, particularly
`cycling, is equally dependent on isometric force and power
`output (Newham, D. J. and Donaldson, N. N. (2007) Acta
`Neurochir. Suppl. 97, 395-402). The available reports on
`magnetic stimulation to generate muscle force in legs of
`normal persons are very rare (Han, T. R. et al. (2006) Am. J.
`Phys. Med. Rehabil. 85, 593-539; Kremenic, I. J. et al. (2004)
`Muscle Nerve 30, 379-381), and there are no reports at all on
`the generation of power in persons with only partially pre(cid:173)
`served or lost sensibility.
`[001 OJ Thus, there still remains a need for training devices
`and corresponding treatment regimens for the physical
`therapy of paretic patients, and in particular for hemi-paretic
`patients having an at least partially preserved sensibility in the
`paralyzed part of the body, that overcome the above-limita(cid:173)
`tions.
`[0011] More specifically, there is a need for devices and
`methods allowing for a more efficient training intensity as
`compared to known treatment systems without causing
`inconvenience for the patients.
`
`SUMMARY OF THE INVENTION
`[0012]
`In a first aspect, the present invention relates to a
`method for the physical therapy of a paretic patient, the
`method comprising:
`
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`2
`
`[0013]
`(a) providing a training device, comprising
`[0014]
`(i) at least one magnetic stimulator for apply(cid:173)
`ing functional magnetic stimulation to at least one
`paralyzed muscle or muscle group of said patient in
`order to induce a periodical movement;
`[0015]
`(ii) at least one guiding element for restricting
`the degrees of freedom of the movement induced by
`applying functional magnetic stimulation; and
`[0016]
`(iii) at least one resistance element for provid(cid:173)
`ing a resistance against the movement induced by
`applying functional magnetic stimulation;
`[0017]
`(b) applying magnetic stimulation to at least on
`paralyzed muscle or muscle group of said patient in
`order to induce a movement;
`[0018]
`( c) impeding the movement of said muscle or
`muscle group via the at least one resistance means; and
`[0019]
`( d) determining the torque of the movement
`induced.
`[0020] Preferably, the periodical movement is a cyclic
`movement.
`[0021]
`In another preferred embodiment, the method fur(cid:173)
`ther comprises:
`[0022]
`( e) adjusting the functional magnetic stimulation
`in such a manner that the torque of the movement
`induced is at least 1.25 Nm.
`[0023]
`In a further preferred embodiment, the patient to be
`treated is a patient having an at least partially preserved
`sensibility in the paralyzed part of the body. In one specific
`embodiment, the patient to be treated is a patient suffering
`from a condition selected from the group consisting of stroke,
`multiple sclerosis, cerebral paresis, and traumatic brain
`injury, and complete (SCI-A) or incomplete (SCI-B, C, D)
`spinal cord injury.
`[0024]
`In a further specific embodiment of the method, the
`at least one guiding means is selected from the group consist(cid:173)
`ing of a stationary cycle, an ergometer, a cross-trainer, a
`rowing machine, a robot, and an exoskeleton.
`[0025]
`In another preferred embodiment of the method, the
`at least one magnetic stimulator comprises any one or more of
`the group consisting of (i) one or more coil(s) selected from
`the group consisting of a ring coil, an elliptic coil, a saddle
`coil, a sleeve coil, a manchette coil or a semicylindrical coil,
`(ii) an acoustic attenuation or damping means: and (iii) a
`cooling system, the cooling system being configured to allow
`the continuous operation of the at least one magnetic stimu(cid:173)
`lator for at least 5 minutes at a frequency of at least 20 Hz.
`[0026]
`In a specific embodiment, the one or more coil(s) of
`the at least one magnetic stimulator is/are arranged in a latero(cid:173)
`ventral position relative to the at least one paralyzed muscle or
`muscle group to be stimulated.
`[0027]
`In another specific embodiment of the method, the
`one or more coil(s) of the at least one magnetic stimulator
`is/are configured to apply magnetic stimulation to a body
`surface area of at least 250 cm2
`. The body surface preferably
`covers the quadriceps muscle group of the patient to be
`treated.
`[0028]
`In one embodiment of the method, the functional
`magnetic stimulation is continuously applied to the at least
`one paralyzed muscle or muscle group of the patient for at
`least 5 minutes during a treatment regimen.
`[0029]
`In an alternative embodiment of the method, the
`functional magnetic stimulation is applied in at least three
`bouts within one day to the at least one paralyzed muscle or
`
`muscle group of the patient during a treatment regimen, each
`of the at least three bouts comprising a continuous application
`for at least two minutes.
`[0030]
`In a second aspect, the present invention relates to a
`training device for the physical therapy of a paretic patient,
`comprising:
`[0031]
`(a) at least one magnetic stimulator for applying
`functional magnetic stimulation to at least one paralyzed
`muscle or muscle group of said patient in order to induce
`a periodical movement;
`[0032]
`(b) at least one guiding element for restricting the
`degrees of freedom of the movement induced by apply(cid:173)
`ing functional magnetic stimulation; and
`[0033]
`( c) at least one resistance element for providing a
`resistance against the movement induced by applying
`functional magnetic stimulation;
`wherein the device is configured in such a manner that the
`torque of the movement induced is at least 1.25 Nm.
`[0034]
`In a further specific embodiment of the device, the at
`least one guiding means is selected from the group consisting
`of a stationary cycle, an ergometer, a cross-trainer, a rowing
`machine, a robot, and an exoskeleton.
`[0035]
`In a preferred embodiment of the device, the at least
`one magnetic stimulator comprises any one or more of the
`group consisting of (i) one or more coil(s) selected from the
`group consisting of a ring coil, an elliptic coil, a saddle coil, a
`sleeve coil, a manchette coil or a semicylindrical coil; (ii) an
`acoustic attenuation or damping means; and (iii) a cooling
`system, the cooling system being configured to allow the
`continuous operation of the at least one magnetic stimulator
`for at least 5 minutes at a frequency of at least 20 Hz.
`[0036]
`In a specific embodiment, the one or more coil(s) of
`the at least one magnetic stimulator is/are arranged in a latero(cid:173)
`ventral position relative to the at least one paralyzed muscle or
`muscle group to be stimulated. Preferably, the one or more
`coils are arranged at a distance of at least 5 mm from the body
`surface area where the stimulation has to be applied
`[0037]
`In another specific embodiment of the device, the
`one or more coil(s) of the at least one magnetic stimulator
`is/are configured to apply magnetic stimulation to a body
`surface area of at least 250 cm2
`. The body surface preferably
`covers the quadriceps muscle group of the patient to be
`treated.
`[0038] Other embodiments of the present invention will
`become apparent from the description hereinafter.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0039] FIG. 1 depicts an isometric and cycling measure(cid:173)
`ment setup according to the invention. Both FMS and FES
`stimulation are possible. A subject with SCI-A performing
`PMS-propelled cycling using two magnetic stimulators can
`be seen: (1) torque transducer, (2) angular encoder, (3) right
`side repetitive magnetic stimulator, ( 4) left side coil ( 4, 5)
`clamps made of foam and Velcro straps. Inset: definition of
`the crank angle
`[0040] FIG. 2 depicts isometric measurements performed
`on a representative subject belonging to the stroke group.
`Starting from the motor threshold, stepwise-increasing FES
`and FMS burst amplitudes were applied, until maximum tol(cid:173)
`erable intensity was reached, in the first and the last part of the
`protocol, respectively. Combined stimulation (the FMS burst
`sequence was superimposed on the FES) was applied in the
`middle part of the protocol.
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`3
`
`[0041] FIG. 3 depicts isometric measurements performed
`on a representative subject belonging to the SCI group. In the
`first part of the test, starting from the motor threshold, step(cid:173)
`wise-increasing FMS burst amplitudes were used until maxi(cid:173)
`mal intensity was reached. In the second part of the test,
`combined stimulation was applied (the FMS burst sequence
`was superimposed twice on the FES).
`[0042] FIG. 4 depicts cadence (upper graph) and crank
`torque (lower graph) profiles measured in a subject of the
`stroke group with right hemiparesis during volitional (gray)
`and PMS-supported volitional (black) cycling conditions
`taken over 15 s periods. Measurement points and 10th order
`polynomial fitting curve are represented. (QUAD): stimula(cid:173)
`tion interval of the right quadriceps.
`[0043] FIG. 5 depicts isometric torque, power, smoothness,
`and symmetry of n=29 chronic post-stroke hemiplegic
`patients measured under volitional, FMS, and FES stimula(cid:173)
`tion conditions. NOTE: Bars and segments plotted represent
`group means±SD. *FMS compared to FES with significance
`of p<0.05; ## Stimulation compared to volitional with sig(cid:173)
`nificance of p<0.001
`[0044] FIG. 6 depicts the isometric torque and power of
`n=l 1 chronic SCI-A patients measured under FMS and FES
`stimulation conditions. NOTE: Bars and segments plotted
`represent group means±SD. Asterisks represent significant
`comparisons ofFES and FMS: *p-0.003; **p<l0-4
`, respec(cid:173)
`tively.
`[0045] FIG. 7 depicts the distribution of the torque gener(cid:173)
`ated by FES (M & M, left panel) or FMS (Magstim, right
`panel) depending on the site( s) of stimulation. The data rep(cid:173)
`resent normalized mean values based on 26 patients. Electri(cid:173)
`cal or magnetic stimulation (of the same intensity) was
`applied to the thigh of the patients at nine different locations
`according to the picture insert. With FES, placing one elec(cid:173)
`trode strictly ventral at the groin line and the other one proxi(cid:173)
`mal to the kneecap results in the highest efficacy. In contrast,
`with FMS, arranging the magnetic stimulator in a latero(cid:173)
`ventral position relative to the surface area, where the stimu(cid:173)
`lation is applied, shows optimal results.
`[0046] FIG. 8 depicts the dependency of the efficacy gen(cid:173)
`erated by FES or FMS on the size of the body surface area, to
`which the stimulation is applied, both with regard to the pain
`perception/intensity of the patients treated (AUC, area under
`the curve; left panel) and the maximal torque determined
`(right panel). The data represent normalized mean values
`based on 26 patients. The following set-ups were used:
`FES-K (positioning of the electrodes close to each other, at a
`distance of about 13 cm, that is, according to the typical
`diameter ofa round magnetic coil); FES-L (standard arrange(cid:173)
`ment of the electrodes as described in FIG. 6); FMS-L (stan(cid:173)
`dard round magnetic coil, diameter 13 cm); andFMS-S (mag(cid:173)
`netic saddle coil with substantially elliptic guidance, the coil
`having a length of about 30 cm and a width of about 20 cm; or
`manchette ( collar, sleeve) coil, e.g. by Magstim Company
`Ltd., Spring Gardens, Whitland Carmarthenshire, Wales,
`UK).
`[0047] FIG. 9 depicts the same experiment as FIG. 8. The
`picture inserts illustrate the respective types of stimulator
`means and the experimental set-ups employed. As apparent
`from the graphs, the use of FMS-S results not only in a
`reduced pain perception but also in the generation of an
`increased maximal torque, as compared to the remaining
`set-ups.
`
`[0048] FIGS. 10-12 schematically illustrate a further
`embodiment of a training device according to the invention.
`FIG. 11 represents an overall illustration of the training
`device. The patient to be treated (suffering from paralysis in
`his legs) is positioned in the training device in an upright
`(standing) position fixed with a chest strap and by means of
`two grip bars for his hands. FMS is applied to his thighs via
`magnetic stimulators having manchette coils ( collar coils,
`sleeve coils) that cover the entire thighs (FIG. 12). The mag(cid:173)
`netic stimulators are controlled via stimulation channels that
`are connected with a computer unit for controlling and/or
`coordinating the movement induced. The exiting current of a
`stimulator is redirected to the manchette coils by means of a
`power-switch controlled by a computer unit (FIG. 10).
`[0049] FIG. 13 depicts another embodiment of a training
`device according to the present invention. It comprises a large
`surface (at least 400 cm2
`) saddle-shaped coil with outer
`dimensions of31 cmx20 cm, an inner cylindrical surface, and
`an aperture angle of 140°.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`[0050] The present invention is based on the unexpected
`finding that the use of large-area magnetic stimulators as
`integrative components of specifically configured training
`devices for the physical therapy of paretic patients results in
`significantly improved training results as compared to both
`functional electrical stimulation and functional magnetic
`stimulation employing conventional magnetic stimulators.
`More specifically, the therapy can be performed with an
`increased intensity and without causing inconveniences for
`the patients to be treated such as significant pain perception or
`skin irritations due to the direct application of electrodes to
`the body parts to be stimulated.
`[0051] The present invention illustratively described in the
`following may suitably be practiced in the absence of any
`element or elements, limitation or limitations, not specifically
`disclosed herein. The present invention will be described with
`respect to particular embodiments and with reference to cer(cid:173)
`tain drawings but the invention is not limited thereto but only
`by the claims. The drawings described are only schematic and
`are to be considered non-limiting.
`[0052] Where the term "comprising" is used in the present
`description and claims, it does not exclude other elements or
`steps. For the purposes of the present invention, the term
`"consisting or" is considered to be a preferred embodiment of
`the term "comprising of'. If hereinafter a group is defined to
`comprise at least a certain number of embodiments, this is
`also to be understood to disclose a group, which preferably
`consists only of these embodiments.
`[0053] Where an indefinite or definite article is used when
`referring to a singular noun e.g. "a" or "an", "the", this
`includes a plural of that noun unless specifically stated oth(cid:173)
`erwise.
`[0054] The term "about" in the context of the present inven(cid:173)
`tion denotes an interval of accuracy that the person skilled in
`the art will understand to still ensure the technical effect of the
`feature in question. The term typically indicates deviation
`from the indicated numerical value off± 10%, and preferably
`±5%.
`[0055] Furthermore, the terms first, second, third, (a), (b),
`( c ), and the like in the description and in the claims, are used
`for distinguishing between similar elements and not neces(cid:173)
`sarily for describing a sequential or chronological order. It is
`to be understood that the terms so used are interchangeable
`
`Allergan EX1075
`Page 17
`
`

`

`US 2010/0331603 Al
`
`Dec. 30, 2010
`
`4
`
`under appropriate circumstances and that the embodiments of
`the invention described herein are capable of operation in
`other sequences than described or illustrated herein.
`[0056] Further definitions of term will be given in the fol(cid:173)
`lowing in the context of which the terms are used. These terms
`or definitions are provided solely to aid in the understanding
`of the invention. These definitions should not be construed to
`have a scope less than understood by a person of ordinary skill
`in the art.
`[0057]
`In a first aspect, the present invention relates to a
`method for the physical therapy of a paretic patient, the
`method comprising:
`[0058]
`(a) providing a training device, comprising
`[0059]
`(i) at least one magnetic stimulator for apply(cid:173)
`ing functional magnetic stimulation to at least one
`paralyzed muscle or muscle group of said patient in
`order to induce a periodical movement;
`[0060]
`(ii) at least one guiding element for restricting
`the degrees of freedom of the movement induced by
`applying functional magnetic stimulation; and
`[0061]
`(iii) at least one resistance element for provid(cid:173)
`ing a resistance against the movement induced by
`applying functional magnetic stimulation;
`[0062]
`(b) applying magnetic stimulation to at least on
`paralyzed muscle or muscle group of said patient in
`order to induce a movement;
`[0063]
`(c) impeding the movement of said muscle or
`muscle group via the at least one resistance element; and
`[0064]
`(d) determining the torque of the movement
`induced.
`[0065] The term "paretic patient" (herein also referred to as
`"paralytic patient"), as used herein, relates to subjects suffer(cid:173)
`ing from an at least partial paralysis of at least one muscle or
`muscle group of their body. The term "paralysis", as used
`herein, denotes the partial or complete loss of muscle function
`for one or more muscle groups. Paralysis can cause loss of
`feeling or loss of mobility in the affected area such as one or
`both legs or arms.
`[0066] Etiologically, paralysis may be caused by various
`types of medical conditions. Most often, it is caused by dam(cid:173)
`age to the nervous system or brain, especially the spinal cord.
`Major causes are stroke trauma, poliomyelitis, amyotrophic
`lateral sclerosis (ALS), botulism, spina bifida, multiple scle(cid:173)
`rosis, and Guillain-Barre syndrome. Temporary paralysis
`may occur during REM sleep, and dysregulation of this sys(cid:173)
`tem can lead to episodes of waking paralysis. Drugs that
`interfere with nerve function, such as curare, may also cause
`paralysis. Many causes of this are varied, and could also be
`unknown. Paralysis may be localized, or generalized, or it
`may follow a certain pattern. Most paralyses caused by ner(cid:173)
`vous system damage are constant in nature; however, there
`are forms of periodic paralysis as well, including sleep
`paralysis.
`[0067]
`In some embodiments of the present invention, the
`patient to be treated is a patient suffering from complete (i.e.
`spinal cord injury type A; SCI-A) or incomplete (i.e. spinal
`cord injury types B, C, and D; SCI-B, C, D) spinal cord injury.
`Typically, such patients suffer from a partial or complete loss
`of muscle function in their legs (i.e. eitherone or both), that is,
`these patients are characterized by paraplegia. They also have
`a partial or complete loss of sensation in their legs (i.e. the
`paralyzed muscles of their legs).
`[0068]
`In preferred embodiments, the patient to be treated
`is a patient having an at least partially preserved sensibility in
`
`the paralyzed part of the body. In other words, such patient
`still have some remaining mobility in the affected paralyzed
`part of the body as well as a partial pain perception, and the
`like. Particularly preferably, the patient to be treated is a
`patient suffering from a condition selected from the group
`consisting of stroke, multiple sclerosis, cerebral paresis, and
`traumatic brain injury. All these medical conditions are well
`known in the art.
`[0069] The training devices described herein are config(cid:173)
`ured to enforce a periodical movement, preferably a cyclic
`movement, of the paralyzed muscles or muscle groups of the
`patient to be treated. The term "enforcing", as used herein, is
`to be understood that it is not sufficient to merely induce a
`movement (i.e. a contraction of the muscle fibers, followed by
`a relaxation) by applying functional magnetic stimulation
`(FMS) to the paralyzed muscles by means of at least one
`magnetic stimulator but that it is also required to guide the
`movement, that is, to restrict the degrees of freedom of said
`movement in such a manner that the movement follows a
`predetermined course or pattern, preferably a closed pattern,
`thus resulting in cycling. It is know that cyclic movements
`( e.g., on a rowing machine or on a bicycle ergometer) result in
`superior training results.
`[0070] This goal is accomplished by providing a training
`device comprising at least one guiding element (i.e. a com(cid:173)
`ponent or unit of the device as defined herein that is config(cid:173)
`ured for guiding the movement induced by applying func(cid:173)
`tional magnetic stimulation). The type of guiding element
`selected for a particular therapeutic regimen depends on sev(cid:173)
`eral factors such as the severity of the paralysis, the part of the
`body affected ( e.g., legs or arms), the overall condition of the
`patient to be treated, and the like. All this parameters are well
`known in the art. It is within the professional skills of the
`physician or medical personnel responsible for the design of
`the physical therapy to select the most appropriate training
`device for a particular patient.
`[0071]
`In preferred embodiments, the at least one guiding
`element is selected from the group consisting of a stationary
`cycle, an ergometer, a cross-trainer, a rowing machine, a
`robot, and an exoskeleton. Any such guiding elements are
`well known in the art and commercially available from dif(cid:173)
`ferent suppliers.
`[0072] Furthermore, in order to improve the therapy out(cid:173)
`come the training devices according to the present invention
`comprise at least