WO2015039206A1 - Diagnostic et traitement de troubles de la motricité - Google Patents

Diagnostic et traitement de troubles de la motricité Download PDF

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Publication number
WO2015039206A1
WO2015039206A1 PCT/CA2013/000804 CA2013000804W WO2015039206A1 WO 2015039206 A1 WO2015039206 A1 WO 2015039206A1 CA 2013000804 W CA2013000804 W CA 2013000804W WO 2015039206 A1 WO2015039206 A1 WO 2015039206A1
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WO
WIPO (PCT)
Prior art keywords
subject
movement disorder
tremor
muscles
movement
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PCT/CA2013/000804
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English (en)
Inventor
Fariborz RAHIMI
Mandar Jog
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Mddt Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
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Priority to PCT/CA2013/000804 priority Critical patent/WO2015039206A1/fr
Priority to AU2014324018A priority patent/AU2014324018B2/en
Priority to ES14845085T priority patent/ES2912410T3/es
Priority to CA2922430A priority patent/CA2922430C/fr
Priority to KR1020167009719A priority patent/KR102259157B1/ko
Priority to EP14845085.1A priority patent/EP3046470B1/fr
Priority to US14/914,591 priority patent/US10231665B2/en
Priority to PCT/CA2014/050893 priority patent/WO2015039244A1/fr
Priority to JP2016543277A priority patent/JP6498678B2/ja
Priority to CN201480063793.XA priority patent/CN105764416B/zh
Priority to PL14845085T priority patent/PL3046470T3/pl
Publication of WO2015039206A1 publication Critical patent/WO2015039206A1/fr
Priority to US16/256,313 priority patent/US11375947B2/en
Priority to JP2019045441A priority patent/JP6703631B2/ja

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Definitions

  • the present invention relates medicine, particularly to methods and systems for diagnosing and treating movement disorders.
  • Tremor is a relatively treatment-resistant symptom of various movement disorders, for example Parkinson's disease (PD) and Essential Tremor (ET), and Essential Tremor is one of the most common movement disorders.
  • PD Parkinson's disease
  • ET Essential Tremor
  • Tremor is assumed to be visually easy to assess and therefore should be relatively easy to treat ET action tremors (postural or kinetic) and PD rest tremors.
  • ET action tremors postural or kinetic
  • PD rest tremors include both muscle composition and directional bias.
  • tremor in ET and PD can involve the head, face, and tongue, the most common site remains the limbs, particularly the upper limbs. Subsequent functional impairment is a result of tremor, and this can be substantially disabling if the dominant arm is affected.
  • tremor symptoms are commonly one-sided while for ET the tremor will be bilateral.
  • the presence of tremor is an obvious visible symptom, which can be cosmetically disabling, making patients feel as though they "stand out” causing emotionally distress. Due to such functional and psychological disability, an effective treatment method for focal tremor remains an important need in affected individuals. While options exist for management of ET and PD tremor, the therapeutic efficacy can still be quite poor with the side effects of medication and danger in brain surgery pose considerable risk, especially in the older age group.
  • Botulinum neurotoxin such as type A or B BoNT A, BoNT B, BTX-A, BTX-B injection therapy has shown efficacy and is indicated for the management of focal disorders such as cervical dystonia (torticollis), blepharospasm and upper limb spasticity, to name a few.
  • BoNT A BoNT A
  • BoNT B BoNT B
  • BTX-A BTX-B
  • BTX-B Botulinum neurotoxin
  • BTX-A Botulinum neurotoxin
  • BTX-B Botulinum neurotoxin such as type A or B injection therapy has shown efficacy and is indicated for the management of focal disorders such as cervical dystonia (torticollis), blepharospasm and upper limb spasticity, to name a few.
  • tremor has been treated with BoNT A
  • the studies have been open-label, or small and the results of BoNT A have not generally been particularly favorable.
  • BoNT A chemodenervation with BoNT A appears to be a viable option for treatment of ET.
  • the lack of functional improvement using BoNT A is a side effect profile produced by the injection. Intramuscular injections can produce substantial weakness in the muscles due to the toxin's well-known action. This weakness is in the muscles injected and also in the adjacent muscles due to the spread of the toxin. It is known that this weakness and spread is dose and volume dependent.
  • the most significant determinant of this side effect may be the selection of the appropriate and most responsible muscles that contribute to the tremor seen and the dosage injected within the muscles, and not to inject non-contributing muscles.
  • the most important component of muscle selection is the clinician's ability to determine the predominant direction of movement of the affected body part. This is true even for dystonia and spasticity, the two other syndromes where BoNT A is successfully used. In these conditions, the movement can be generally fairly stereotyped and the predominant postures of the body parts affected can be visually assessed by the clinician.
  • the assessment of the movement and the subsequent injection pattern determination becomes that much more difficult.
  • the tremor of PD and ET have been assumed to having well established
  • the wrist can flex and extend, and show ulnar and radial deviation, while at the same time the elbow may show pronation-supination and flexion-extension.
  • the shoulder can also flex- extend and have abduction-adduction movements. Such multidimensional motion is then summed in producing the actual tremor.
  • the clinician has to then visually decompose these components and then determine the relative contributions of each in order to estimate which muscle groups to select for injection. In most cases this is a very difficult task and may over- or under-estimate the movement subcomponents. If this happens, the injections of BoNT A may be given in incorrect muscle groups resulting in suboptimal benefit and increased side effects.
  • a system for obtaining and analyzing data for overall joint motion from a plurality of joints of a subject experiencing a movement disorder comprising: a plurality of kinematic sensors configured to be placed on a body of a subject experiencing a movement disorder proximal a plurality of joints of the subject, the kinematic sensors selected to measure overall joint motion with sufficient degrees of freedom for individual joints so that data collected by the sensors can be deconstructed into multiple degrees of freedom for individual joints and analyzed to provide amplitude of the movements caused by the movement disorder, and relative contributions from and directional bias for each muscle group that may be implicated in the movement of each joint; and, a non-transient, physical memory device configured to accept data collected by the kinematic sensors and having computer executable instructions stored thereon to deconstruct the data collected by the sensors for overall joint motion into multiple degrees of freedom for individual joints and analyzing the multiple degrees of freedom for the amplitude of the movements caused by the movement disorder and the relative contributions from and directional bias for each muscle
  • a method of determining muscle groups involved in a movement disorder in a subject comprising deconstructing sensor data for overall joint motion collected from a plurality of joints of a subject experiencing a movement disorder into multiple degrees of freedom for individual joints and analyzing the multiple degrees of freedom for relative contributions from and directional bias for each muscle group that may be implicated in the movement of each joint, the deconstructing and/or analyzing accomplished by computer executable instructions therefor stored in a non-transient, physical memory device.
  • a method of determining a treatment regimen for treating a movement disorder in a subject comprising: determining amplitude and muscle composition of movements of a subject caused by a movement disorder by deconstructing sensor data for overall joint motion collected from a plurality of joints of a subject into multiple degrees of freedom for individual joints and analyzing the multiple degrees of freedom for amplitude of the movements caused by the movement disorder and for relative contributions from each muscle group that may be involved in the movement of each joint caused by the movement disorder, the deconstructing and/or analyzing accomplished by computer executable instructions therefor stored in a non-transient, physical memory device; and, determining a personalized treatment regimen for the subject from the amplitude and relative contribution of each muscle group to the movements caused by the movement disorder.
  • a method of treating a subject with a movement disorder comprising: determining amplitude and muscle composition of movements of a subject caused by a movement disorder by deconstructing sensor data for overall joint motion collected from a plurality of joints of a subject into multiple degrees of freedom for individual joints and analyzing the multiple degrees of freedom for amplitude of the movements caused by the movement disorder and for relative contributions from each muscle group that may be involved in the movement of each joint caused by the movement disorder; and, administering to the subject a personalized treatment regimen determined from the amplitude and relative contribution of each muscle group to the movements caused by the movement disorder.
  • Movement disorders involve the involuntary movement of body segments. It has now been found that any given involuntary movement may comprise contributions from any number of muscles, including muscles distal from the body segment affected by the involuntary movement. Therefore, in the present invention, a plurality of kinematic sensors are placed proximal a plurality of joints and used to measure overall joint motion with sufficient degrees of freedom for individual joints so that data collected by the sensors can be deconstructed into multiple degrees of freedom for individual joints and analyzed to provide relative contributions from each muscle group that may be implicated in the movement of each joint. The analysis also preferably provides directional bias for the muscle groups implicated in the movement of each joint. In this way, the actual muscle group composition, and preferably the directional bias within the muscle group as well, for any given abnormal movement can be determined, and a therapy developed to specifically target the muscle groups involved in that abnormal movement.
  • Movement disorders include, for example, tremor (e.g. Parkinson's disease (PD), essential tremor (ET), writing tremor), dystonia (e.g. torticollis or cervical dystonia (CD), task-specific writing dystonia), ataxia, chorea, myoclonus, ballismus, dysmetria, postural disorders, spasticity (e.g. focal spasticity from stroke, upper limb spasticity), blepharospasm, multiple sclerosis and cerebral palsy.
  • tremor e.g. Parkinson's disease (PD), essential tremor (ET), writing tremor
  • dystonia e.g. torticollis or cervical dystonia (CD), task-specific writing dystonia
  • ataxia chorea
  • myoclonus e.g. torticollis or cervical dystonia (CD)
  • task-specific writing dystonia e.g. torticollis or cervical dystonia (CD)
  • ataxia chorea
  • the neck may comprise a plurality of joints and measurements made at the neck may be considered to involve measuring motion at a plurality joints.
  • muscle groups whose contribution to the abnormal movement may be determined include but are not limited to lateral shift/tilt, saggital shift/tilt, axial rotation, outward/inward medial rotation, retraction/protraction and inversion/eversion muscle groups, as well as flexion-extensor (F/E), ulnar-radial (U/R), pronation-supination (P/S) and abduction-adduction (A/A) muscles.
  • F/E flexion-extensor
  • U/R ulnar-radial
  • P/S pronation-supination
  • A/A abduction-adduction
  • the muscle groups of greatest importance may be one or more of lateral shift/tilt related muscles, saggital shift tilt related muscles, axial rotation neck muscles, flexion-extensor (F/E) muscles, ulnar-radial (U/R) muscles, pronation-supination (P/S) muscles and abduction-adduction (A/A) muscles.
  • F/E flexion-extensor
  • U/R ulnar-radial
  • P/S pronation-supination
  • A/A abduction-adduction
  • muscles include flexor carpi radialis, flexor carpi ulnaris, brachioradialis, extensor carpi radialis, extensor carpi ulnaris, pronator teres, pronator quadratus, supinator, biceps, pectoralis, teres major, triceps, deltoids, supraspinatus, infraspinatus, semispinal capitis, splenius capitis, trapezius, levator scapulae, sternocleidomastoid, scalene muscles, splenius cervicalis, and longissimus capitis.
  • joints and muscle groups of the upper body particularly especially the upper limbs and neck.
  • Kinematic sensors include any device that can determine direction of motion of a body segment.
  • the sensors may be kinematically connected to the body segment or may track the body segment without being connected thereto.
  • Kinematic sensors may include, for example, one or more of a transducer, inclinometer, electromagnetometer, potentiometer, camera-based visible light tracking, camera-based IR-tracking, proximity sensor, strain gauge, magnetic or electromagnetic tracker, inertial sensor, accelerometer, gyroscope, surface EMG, torsiometer (e.g. electro-torsiometer), goniometer (e.g. electro- goniometer), load cell sensor or full body inertial measurement unit.
  • Kinematic sensors may be kinematically connected to a subject by, for example, direct attachment to the subject's body segment or attachment to an article of clothing, jewelry or the like.
  • the sensors could be built into a body suit (e.g. an inertial measurement unit) worn by the subject.
  • Kinematic sensors that do not require attachment to the body segment may be positioned in line-of-sight of the body segment.
  • the number of kinematic sensors required depends on the type of sensor used, the number of joints being measured and the placement of the sensors on the subject's body segments. Sensors capable of detecting motion with more than one degree of freedom and/or detecting motion at a specific joint independent of motion from other body segments are particularly useful, for example goniometers or torsiometers, although in practice a plurality of types of kinematic sensors may be used. For example, a torsiometer placed diagonally across the subject's wrist provides better measurement of wrist motion than an inclinometer placed on a dorsal surface of a hand.
  • a plurality of different types of sensors may be used to compensate for the shortcomings of any one type of sensor; for example, if one sensor type has less than three degrees of freedom, then other sensor types may be desired. However, using only one sensor type is possible if that sensor type has at least three degrees of freedom. Data may be transmitted from the sensors through wired connections or wirelessly.
  • F/E, U/R, P/S, A/A) and the directional bias within each joint muscle group provides information to determine the individual muscles involved in and their respective contributions to the abnormal movement. This permits accurate targeting of the muscles for therapy for the abnormal movement in question.
  • therapy may be based on relative contribution of each muscle to the abnormal movement, the contribution of each muscle being determined from the analyzed sensor data showing the muscle group composition for the movement and the directional bias within each of the muscle groups that are part of the composition.
  • the analysis of sensor data may be embodied in a computer program or software.
  • the software may have the capability of simultaneously recording and analyzing body movements and recognizing what abnormal movements are. Or, body movement data may be collected first, followed by analysis by the software.
  • the software may be able to detect, for example, tremor movements as well as abnormal postures (e.g. asymmetry in neck position) found at limb joints (e.g. wrist, elbow, shoulder, neck, ankle and knee).
  • the software filters and analyzes the raw sensor data related to motions at each joint into clinically relevant information, e.g. muscle composition and directional bias. This may be done following an assessment conducted by medical staff with hardware sensors for recording the movement disorder from the patient.
  • the software may summarize the values collected for each channel of sensor signal after calibration and assessment.
  • Signal processing and filtered band-pass may also be applied to the recorded signal along with the data during assessment, which may be compared to values from the calibration from which the system processes the positional bias of the joint, the tremor amplitude and angular severity of the joint composition, such as flexion-extension, ulnar- radial, pronation-supination, and abduction-adduction.
  • RMS or power spectrum may be done for each of the degrees of freedom to process severity and composition data.
  • the signals collected at each joint may be individually processed for each unique limb position during patient assessment. Treatment regimens for movement disorders may encompass any useful treatments for the disorders of interest.
  • the treatment regimen comprises focal muscle treatment since one of the strengths of the present system and method is accurate determination of the particular muscles involved in the movement disorder.
  • the treatment regimen may be, for example, injectable or non-injectable.
  • Injectable treatment regimens involve injecting a drug or mixture of drugs (e.g. botulinum toxin (e.g. BoNT A, BoNT B, BTX-A, BTX-B), xylocaine, marcaine, or a nerve or muscle blocking agent) into one or more of the muscles involved in the abnormal movement.
  • a drug or mixture of drugs e.g. botulinum toxin (e.g. BoNT A, BoNT B, BTX-A, BTX-B), xylocaine, marcaine, or a nerve or muscle blocking agent
  • Non-injectable treatments include, for example, electromagnetic (e/m) radiation therapy, electromyogram stimulator, functional electrical stimulation, active orthotic device, ultrasound therapy, acupuncture, trans-cranial magnetic stimulation, topical application of drugs and the like. Combinations of treatments may be employed, for example drug injection together with muscle stimulation therapy.
  • the drug may be administered to each muscle at a dosage based on the muscle group composition, the directional bias within each muscle group implicated in the abnormal movement and/or on the amplitude of the abnormal movement.
  • the drug may be administered to each muscle at a dosage selected based on the amplitude of the abnormal movement. Amplitude may be measured in degrees as an angular deviation from 0. People without the abnormal movement typically show muscle movement amplitudes on the order of 0.03 to 0.07 degrees. Whether or not a specific deviation is sufficient to warrant administration of the drug to a muscle depends to some extent on the joint in question.
  • an abnormal movement having an amplitude at the wrist of less than about 0.3 degrees is not treated.
  • an abnormal movement having an amplitude of less than about 0.15 degrees is not treated.
  • the concentration of the drug may be especially determined by the size of the muscle group being treated. Muscles that have a greater contribution to the abnormal movement may be targeted with more of the drug than those with less contribution. Dosages of drugs will depend to a certain extent on the particular drug being used. Further, it is possible to avoid injecting drugs into muscles that have no contribution to the abnormal movement. This reduces side effects and the amount of drug that is needed to be effective at treating the movement disorder.
  • the concentration of the drug may be increased, for example doubled, to reduce the occurrence of volume- dependent weakness in the muscles injected and also in the adjacent muscles due to the spread of the toxin.
  • a dose range of 10U-30U of BoNT A can be used for each shoulder related muscle, 10U-30U for every elbow tremor contributing muscles, and 5U-15U for the various forearm muscles that control the wrist, all of which are adjusted based on amplitude of tremor.
  • composition and directional bias in one patient shows that the tremor is predominantly flexor at the wrist
  • a physician can optimize dosage based on medical experience to inject a higher dose in the flexor carpi radialis and flexor carpi ulnaris, and give lower doses to the extensor carpi radialis and extensor carpi ulnaris muscles.
  • Treatment regimens may be optimized and/or rehabilitation therapies implemented by iterating the methods of the present invention.
  • a treatment regimen may be optimized after a first application of a therapy by analyzing the deconstructed kinematic sensor data for joints of the subject obtained for the first application of the therapy and the muscles and therapy parameters (e.g. drug dosages) selected for the first application in light of the outcome of the subject after the first application of the therapy. The results of such analysis may be used to determine adjustments to be made to location and extent (e.g. drug dosage) of the therapy in a second application of the therapy. This process may be repeated until an optimized regimen is obtained.
  • a subject initially visits a clinician with a view to reducing the effects of the abnormal movement for reasons both cosmetic and functional.
  • the clinician would assess the subject on the usual clinical scales and classify the subject based on the type of abnormal movement.
  • the subject's strength in the affected limbs is measured and then the subject is subjected to kinematic assessment as described herein.
  • the subject is fitted with kinematic sensors and the sensors calibrated. During calibration and subsequent data collection, it may be important to position the subject's limbs in such a way as to eliminate bias due to gravity.
  • Sensor data may then be collected on all of the abnormal movements of the subject, and the sensor data processed to determine severity (amplitude), angle and bias of each abnormal movement.
  • the amplitude, angle and bias may then be deconstructed into muscle composition and directional bias, which yields the particular muscles involved in and their respective contributions to each abnormal movement.
  • a treatment regime may be determined by a physician that indicates where the subject would be treated (i.e. which muscles) and the extent of therapy (e.g. the dosage of drug at each muscle).
  • the subject In a follow-up visit to the clinician, for example 1-10 weeks after the initial treatment (e.g. 6 weeks), the subject is once again clinically assessed and strength measurements taken. Kinematic assessment is again performed and the sensor data eventually deconstructed to muscle group composition and directional bias. Based on the clinical and kinematic assessments compared to the assessments performed in the first visit, the clinician determines what, if any, improvement has occurred and whether any optimization to the treatment regimen is possible.
  • a third visit for example 11-20 weeks (e.g.16 weeks) after the initial visit, the clinical assessment including strength measurements is repeated and the information generated from all three visits is used to determine whether no dose, the same dose, a higher dose or a lower dose is required, as well as any changes to muscle groups selected should be implemented.
  • a time course of treatment may be prescribed based on kinematic assessment and recurrence of the abnormal movements after initial treatment.
  • Initial treatments may result in a decrement in the magnitude and/or frequency of the abnormal motions observed, and repeated application of the therapy guided by kinematic assessment may reduce the magnitude of the motions and/or increase the amount of time required between therapy events. This leads to long term suppression of the disorder.
  • movement disorders may also comprise a neurological component in which the brain has been conditioned over time to trigger the abnormal movements associated with the movement disorder. Treatment of the muscle involved to reduce the severity of the abnormal movements may help re-condition the brain providing a feedback loop to reduce abnormal movement without the aid of therapy. Therefore, accurate muscle selection and treatment parameters (e.g.
  • BoNT A injection therapy increases the effectiveness of BoNT A, reduces the dose required, increases functionality of treated limbs and reduces muscle weakness, muscle weakness having been a side effect of BoNT A therapy.
  • objective sensor data analyzed in a consistent way permits accurate tracking of the progression of the movement disorder following medical intervention.
  • Fig. 1 depicts placement of kinematic sensors on forearm, hand and wrist of a subject for measuring joint movement during tremor.
  • Tremor was measured by angle at the wrist, and by acceleration at the interphalangeal joint, where a) is an electro- goniometer measuring wrist F/E and R/U, b) is an inclinometer measuring forearm P/S, and c) is a light-weight 3D accelerometer collecting distal finger movements as a measure of overall tremor severity.
  • Fig. 2 depicts a graph showing amplitude, composition, and directional bias of tremor at the wrist for PD subject #9.
  • the top row shows the RMS (root mean square) combined amplitude of the 3-DOF in wrist tremor.
  • RMS root mean square
  • mean and standard deviations of the amplitude for the three trials are presented.
  • the grand average (horizontal line) is also presented.
  • Fig. 3A depicts a graph showing finger amplitude for overall tremor severity for ET and PD averaged over 3 trials of each condition.
  • Fig. 3B depicts a graph showing composition of wrist tremor contrasted between rest and posture tasks for ET.
  • Fig. 3C depicts a graph showing composition of wrist tremor contrasted between rest and posture tasks for PD.
  • Fig. 3D depicts a graph showing directional bias across 3-DOF in wrist tremor for ET.
  • Fig. 3E depicts a graph showing directional bias across 3-DOF in wrist tremor for PD. Contribution was calculated for each DOF (F/E, R/U, and P/S) amplitude with respect to the sum of all 3-DOF amplitudes. Confidence interval outside zero (neutral) was considered significant bias.
  • Fig. 4 depicts a graph illustrating wrist tremor complexity in 3 DOF for 3 subjects. Each line represents the motion of the wrist recorded every 0.1 sec. Movement of the dot along the X-axis represents F/E, along the Y-axis R/U, and the line rotation (angle) representing P/S.
  • Fig. 4A for PD subject #6 at rest, the tremor was predominantly P/S with minimal F/E or R/U deviations.
  • Fig. 4B for PD subject #2 in posture the tremor was a combination of F/E and P/S.
  • Fig. 4C for ET subject #10 in posture the tremor was predominantly F/E with slight P/S.
  • Figs. 5A-D depict location of different sensors on dorsal surface of hand, wrist, elbow, forearm and shoulder of a subject for assessing tremor in the subject's arm.
  • Fig. 5A depicts the placement of torsiometer, goniometer and accelerometric sensors for the shoulder (goniometer), elbow (goniometer), wrist (goniometer), dorsal surface of hand (accelerometer) and front of forearm (torsiometer).
  • Fig. 5B shows the placements of I Us sensors on the whole arm.
  • Fig. 5C demonstrates the positioning of markers needed for the capture of tremor movements using camera and IR tracking devices.
  • Fig. 5D shows the placement of magnetometric sensors in order to record tremor in the arms.
  • Fig. 6A depicts a flowchart showing how sensor data collected from the sensors in the sensor set up of Fig. 5A are used to obtain measures of tremor angle, severity and composition at each joint in an upper limb such as an arm.
  • Fig. 6B shows a sample graph of the raw signal data following assessment with no data processing.
  • Figs. 6C-6D show a 20 out of 1150 second sample of the raw tremor signal undergoing filter band pass along with preliminary composition analysis.
  • Fig. 6E depicts a flowchart showing how sensor data collected from sensors are used to obtain measures of tremor angle, severity and composition for neck and head.
  • Figs. 7A-B depict graphs showing muscle composition and directional bias for the right arm tremor assessed in the subject in the sensor setup of Fig. 5A before (Fig. 7A) and after (Fig. 7B) treatment with Botulinum neurotoxin type A (BoNT A) injection therapy.
  • Fig. 7C shows muscle composition and directional bias measured at the time of the next injection visit.
  • Figs. 8A-D depict location of different sensors on head, neck and shoulder of a subject for assessing tremor and dystonia in the subject's neck and head.
  • Fig. 8A-D depict location of different sensors on head, neck and shoulder of a subject for assessing tremor and dystonia in the subject's neck and head.
  • FIG. 8A shows the placement of torsiometer on the neck and inclinometers on the head and shoulders.
  • Fig. 8B shows the placement of IMUs for measuring neck tremor and dystonia.
  • Fig. 8C shows the location of markers needed to accurately utilize camera and IR based tracking devices.
  • Fig. 8D shows the location of magnetometers on the head and shoulder needed for measuring cervical dystonia.
  • Figs. 9A-B depict graphs showing head and neck movement data for the head and neck tremor assessed in the subject of Fig. 8A before (Fig. 9A) and after (Fig. 9B) treatment with Botulinum neurotoxin type A (BoNT A) injection therapy.
  • BoNT A Botulinum neurotoxin type A
  • Example 1 Kinematic Assessment of Tremor Composition and Directional Bias in a Wrist
  • kinematic methodology is well established for studying the dynamics of movement in the upper limb. Technological advances have made this a reliable and viable option in the characterization of complex movements such as tremor.
  • Wrist tremor for example, is variable and has three directions of movement: flexion/extension (F/E), radial/ulnar (R/U), pronation/supination (P/S).
  • F/E flexion/extension
  • R/U radial/ulnar
  • P/S pronation/supination
  • visually-guided judgment of the complexity of movement over time may be difficult and inaccurate.
  • kinematic studies to date have not deconstructed the complex movements into their muscle compositions and directional biases within muscle groups. As described herein, kinematic methodology can accurately allow for assessment of all these variables, leading to improved characterization of tremor dynamics.
  • ID participant's identification number
  • Kinematic devices were used to record composition of wrist tremor, in addition to overall tremor amplitude/severity.
  • Wrist flexion/extension (F/E) and radial/ulnar deviation (R/U) were measured using a twin flexible axis electro-goniometer (SG65, Biometrics Ltd) placed across the wrist joint.
  • Forearm pronation/supination (P/S) was measured using a 2D inclinometer (Noraxon®) secured to the dorsal surface of the hand. Together, the sensors provided 3 degrees of freedom (DOF) angular measurements at the wrist.
  • Finger tremor was also recorded using a linear accelerometer (3D, 6g, Noraxon®) at the distal interphalangeal joint of the middle finger giving three degrees of linear acceleration.
  • Fig. 1 illustrates placement of the sensors.
  • This measure provided an overall measure of tremor severity. While the electro- goniometer recorded relative motion of the wrist and the forearm, the inclinometer and the accelerometer had a global inertial frame of reference. The sensors were attached to standard positions using medical grade tape, and were connected to a laptop through TeleMyo 2400T G2 and PC interface. Data were digitally sampled (at 1500Hz, using MyoResearch XP Master Edition 1.08.09 software, Noraxon®) and saved for off-line processing and analysis.
  • Tremor acceleration amplitudes usually have skewed distributions and log- transformation. Therefore, overall finger tremor (combined 3D) amplitudes were log- transformed before analysis. The log-transformed data met criteria for parametric analysis. Average amplitude over three trials was compared in a 2-way ANOVA between effects of diagnosis and repeated measures for rest and postural positions. Alpha level was set at .05 and Tukey's HSD test was conducted for post-hoc analysis.
  • the averaged directional bias data over three trials met criteria for parametric analysis.
  • a separate univariate ANOVA compared directional bias in each of the wrist tremor components (F/E, R/U, P/S). Confidence intervals (95%) were used to examine if the average bias for a component was significantly positive or negative.
  • Statistical analyses were performed in STATISTICA® 8.0, StatSoft Inc.
  • kinematic analysis data was presented in a randomized order to the same clinician who was blinded to the clinical assessment of the patients.
  • Kinematic data gave the direction of the movement, the amplitude and the relative contributions of each tremor component without any identifiers (see Fig. 2). These pairs included P/S at the forearm, F/E and R/U at the wrist.
  • W-R wrist angular tremor (degree) at rest
  • W-P wrist angular tremor (degree) in posture
  • FIG. 3D show that the injections should be equally divided between the muscle groups contributing to F/E and R/U while pronators should receive more than supinators, because pronators were statistically biased from neutral. It should be noted that this is a global impression of contribution and personalized muscle injections are based on the subject's individual assessment and unique characteristics.
  • Fig. 3C also shows that in PD tremor F/E and P/S were equally significant at rest and in posture and contributed significantly higher than R/U in both conditions. This suggests that when considering injections for PD tremor, both of these movement subcomponents should be injected from the start and probably in equal amounts.
  • tremor deconstruction showed motion was dominated (>70% contribution) by 1-DOF in ET (rest: 0%, posture: 36%) and PD (rest: 23%, posture: 23%).
  • Task variation in ET and PD resulted in change in amplitude and composition. Amplitude significantly increased from rest to posture in ET, but this increase was not significant in PD. Composition change was significant in ET only.
  • Directional bias in each DOF was observed at the wrist joint for pronation in ET, and for extension, ulnar deviation, and pronation in PD.
  • Agreement between Scheme 1 (visual) and Scheme 2 (kinematic) in selecting muscles that contribute to tremor was then evaluated. When a specific muscle appeared in both the schemes, an agreement number of 1 was assigned, while if the muscle appeared in only one of the two schemes, the number was 0. The determination was done for every muscle that was used in the schemes and the list is presented, with the agreements in Table 3.
  • Presence numbers of subjects where that particular muscle was chosen
  • Kinematic analysis of tremor such as outlined in this Example, to determine composition and directional bias of muscles involved in the tremor provides an objective, non-visual method of assessing where and how much drug to administer to a subject to control the tremor. This analysis highlights the limitation of visual assessment of the complexities of tremor in ET and PD.
  • Example 2 Treating Arm Limb Tremor and Deviation Using Kinematic Analysis and Botulinum neurotoxin type A (BoNTA) Injection for Wrist, Elbow and Shoulder
  • BoNTA Botulinum neurotoxin type A
  • Wrist tremor is highly variable and has three directions of movement: flexion/extension (F/E), radial/ulnar (R/U), and pronation/supination (P/S), as mentioned in Example 1.
  • Elbow tremor has one direction of movement done by flexion/extension (F/E), while shoulder tremor has three directions of movement: flexion/extension (F/E), abduction/adduction (A/A), and internal/external rotation.
  • Example 4 With same criteria as Example 1 , 18 ET and 23 PD patients, different recruits from Example 1 , were enrolled into a 8 month long arm tremor study with baseline data collected (Table 4)
  • Kinematic devices were used to record composition of wrist tremor, in addition to overall tremor amplitude/severity.
  • Wrist flexion/extension (F/E) and radial/ulnar deviation (R/U) were measured using a twin flexible axis electro-goniometer (SG150, Biometrics Ltd) placed across the wrist joint.
  • Forearm pronation/supination (P/S) was measured using a single flexible axis electro-torsiometer (Q150, Biometrics Ltd) placed along the inner forearm, parallel to the flexor carpi radialis.
  • the sensors provided 3 degrees of freedom (DOF) angular measurements at the wrist.
  • DOF degrees of freedom
  • Hand tremor was also recorded using a linear accelerometer (3D, 6g, Noraxon®) on the hand giving three degrees of linear acceleration.
  • a single flexible axis electro-goniometer was placed on the elbow joint to measure flexion/extension (F/E) and another twin axis electro-goniometer was placed on the shoulder joint to measure flexion/extension (F/E) and abduction/adduction (A/A).
  • Fig. 5A illustrates unique placement of these sensors types for measuring wrist, elbow and shoulder tremors.
  • a sensor placed diagonally across the wrist was particularly useful for collecting data on a full range of wrist motion. All recordings were performed in the seated position with a similar PC interface as mentioned in Example 1.
  • Calibration for wrist was also similar to the description found in Example 1 with the addition of calibration at the elbow and shoulders which was individually done by placing the elbow at neutral F/E, followed by neutral F/E and neutral A/A positions for shoulder. Subjects then performed a series of 7 tasks to measure tremor, first by placing the arm and hand relaxed and at rest on the patient's own lap (rest-1 ), and then resting the arm on support surface (rest-2). The hand may be turned with the palm facing to the side to reduce gravitational influence on the tremor.
  • Amplitude for 3D hand tremor, amplitude for 3-components of wrist tremor, and directional bias of each component during trials were calculated for 3-trials of rest-1 , rest-2 and for 3-trials of post-1 , post-2 and for 3-trials for no load and full load.
  • Three dimensions of linear acceleration at the hand were combined (RMS) to provide overall tremor severity.
  • Percent contribution for each of the three components to wrist tremor was determined with respect to a combination of summed 3D angular amplitude (F/E, R/U, and P/S,) and one component at the wrist (F/E). Likewise, at the shoulder the percent contribution for the two components was determined for F/E and A/A.
  • the maximum tremor amplitude is 1.22 as shown in the first panel in Fig. 7A.
  • the graphed results are correlated to the sub-movements flexion-extension (F/E) and radial-ulnar (R/U) (see second panel in Fig. 7A).
  • the tremor amplitudes relating to (F/E) and (R/U) wrist movements help the clinical evaluation of the severity of deviation/bias the wrist has from a neutral/normal position (see third panel in Fig. 7A).
  • the maximal amplitudes at these two sub-movements are then ranked from the top two arm postures in terms of priority of concern at the wrist.
  • a dosing paradigm as well as selection of which muscles for injection may be determined.
  • the tremor amplitude (0.12 as seen in the first panel of Fig. 7A) was found to be clinically significant.
  • the pronation-supination (P/S) and radial-ulnar (R/U) sub-movements at the elbow were assessed separately.
  • the clinician was fully aware during the kinematic assessment that the measured tremors at the elbow have contributions to the wrist movements as well being influenced by the biceps. Based on the elbow composition, equal amounts would be injected at the elbow muscles; however, if supination deviation/bias was significant, additional dosing of medication would be given at the bicep. This makes injection at the elbow different for elbow flexor compared to extension as the elbow flexion does supinate.
  • F/E flexion-extension
  • A/A abduction-adduction
  • the muscles selected for injection could be taken from the following list: flexor carpi radialis, flexor carpi ulnaris, brachioradialis, extensor carpi radialis, extensor carpi ulnaris, pronator teres, pronator quadratus, supinator, biceps, pectoralis, teres major, triceps, deltoids, supraspinatus, and infraspinatus.
  • flexor carpi radialis, flexor carpi ulnaris, extensor carpi radialis, extensor carpi ulnaris, pronator teres, pronator quadratus, biceps, pectoralis, triceps, and supraspinatus were selected for BoNT A injection.
  • Example 3 Treating Head and Neck Tremor with Torticollis Using Kinematic Analysis and Botulinum neurotoxin type A (BoNT A) Injection
  • a subject's head and neck tremor was measured and analyzed generally in accordance with the kinematic method described in Examples 1 and 2.
  • sensors were placed on the subject's body as depicted in Fig. 8A, with sensors on the head and neck of the subject.
  • Fig. 8A depicts sensors on the head, shoulder and neck.
  • the torsiometer was placed at the back of the neck while two inclinometers are placed on both shoulders and one inclinometer is placed on the side of the patient's head.
  • the torsiometer was able to detect rotational tremor and dystonic movements along with the rotational range of movement.
  • the two inclinometers on the shoulders are able to capture shoulder elevation.
  • the inclinometer located on the side of the patient's head was used to measure tremor and dystonic movements for lateral left-right tilts and forward- backward head sagittal tilt. This same inclinometer on the head was also able to record the range of motion for caput and collis head movements during lateral left-right tilts and forward-backward sagittal tilt. Patients were positioned in calibration positions prior to each kinematic recording by adjusting the patient's head to neutral position with minimal rotational, lateral tilt and forward-backward sagittal tilt. The head is also gently held still to prevent tremor and dystonic movements during calibration. The assessment involves 12 tasks.
  • the first assessment was done by asking the patient to look forward while in a seated position and to keep the head and neck as relaxed as possible without inhibiting any involuntary movements.
  • the first task is important for determining the head positional bias when the patient typically looks forward.
  • the patient was asked to close their eyes in the same relaxed position.
  • the third and fourth tasks asked the patient to rotate their head as far left and then as for right as they can.
  • the fifth to eighth tasks involved having the patient with their eyes opened position their head tilted upwards in caput and collis positions, followed by caput and collis positions with head tilted downward.
  • the last four tasks required the patient to tilt their head to the left and right side in again caput and collis positions. All tasks are performed at least for 3 trials.
  • the average values during calibration for each degree of freedom are calculated and are used as reference point for comparison with other tasks the patient performs.
  • the signal goes through a band-pass filter, then the average amplitude of tremor during tasks one and two (Rest Eye-open, Rest -Eyes-Closed) are calculated for all three trials to be displayed as a boxplot.
  • the data analyzed and provided to the physician are one of three types of graphs.
  • the first graph shows the abnormal bias values while the head is supported in a neutral position, relaxed and not resisting any tremor or dystonic movements.
  • the second graph shows the tremor amplitude (RMS angles, in degrees) just during rest condition with eyes open and closed.
  • the third graph shows the range of motion of the neck and head during task performance. This process is illustrated in Fig. 6E.
  • the data was provided to a clinician for review. First, whether treatment is needed was assessed at each of the three primary positions, which are lateral tilt, rotational, and sagittal motions based on the kinematic values. These three primary positional kinematic values represent the deviation away from normal head position, which should have a value of zero. Shoulder rise-drop is also examined to determine if treatment is required.
  • the kinematic results show the need to further assess tilt, rotational and sagittal kinematic value.
  • the individual kinematics recordings for each motion are also assessed for difference between eyes open (Eye-O) and eyes closed (Eye-C) (see top panel in Fig. 9A). Based on the kinematic values, it is evident that the subject has head posture deviation of tilting the head to the right.
  • the kinematic values also show the subject's head has a forward tilt (chin downward) and a head rotation to the left.
  • tremor angular amplitude in each primary position is assessed.
  • the kinematic data (Fig. 9A, second panel) shows most tremor in the tilt motion, followed by rotational motion and lastly the sagittal forward-backward motion. With both head deviation and tremor contributions assessed, the subject's range of neck motion is assessed from the kinematic data (Fig. 9A, third panel) to assess movement abnormalities.
  • a dosing table is constructed and muscles needed for injection selected to help correct for head posture, tremor and possible range of motion problems.
  • the right and/or left muscles selected for injection could be taken from the following list: semispinalis capitis, splenius capitis, trapezius, levator scapulae, sternocleidomastoid, scalene muscles, splenius cervicalis, and longissimus capitis.
  • the right and left splenius capitis, right and left sternocleidomastoid, and right levator scapulae were selected for BoNT A injections.

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Abstract

La présente invention concerne un système permettant d'obtenir et d'analyser des données pour le mouvement global des articulations chez un sujet atteint de troubles de la motricité impliquant une pluralité de capteurs cinétiques conçus pour être placés sur un corps d'un sujet atteint de troubles de la motricité proximale affectant plusieurs articulations du sujet. Les capteurs cinétiques sont choisis pour mesurer le mouvement global de l'articulation avec des degrés suffisants de liberté pour des articulations individuelles de sorte que les données recueillies par les capteurs peuvent être déconstruites en de multiples degrés de liberté pour des articulations individuelles et analysées pour donner de l'amplitude aux mouvements souffrant de trouble de la motricité et/ou contribuer de manière relative depuis et/ou de la polarisation directionnelle pour chaque groupe de muscles qui peut être impliqué dans le mouvement de chaque articulation. Ledit système fournit des méthodes permettant de définir un schéma thérapeutique destiné à traiter le trouble de la motricité, moyennant quoi le schéma thérapeutique se base sur l'amplitude des mouvements et/ou la contribution relative et/ou la polarisation directionnelle de chaque groupe de muscles aux mouvements provoqués par les troubles de la motricité.
PCT/CA2013/000804 2013-09-20 2013-09-20 Diagnostic et traitement de troubles de la motricité WO2015039206A1 (fr)

Priority Applications (13)

Application Number Priority Date Filing Date Title
PCT/CA2013/000804 WO2015039206A1 (fr) 2013-09-20 2013-09-20 Diagnostic et traitement de troubles de la motricité
EP14845085.1A EP3046470B1 (fr) 2013-09-20 2014-09-18 Diagnostic et traitement du trouble du mouvement
ES14845085T ES2912410T3 (es) 2013-09-20 2014-09-18 Diagnóstico y tratamiento de trastornos del movimiento
CA2922430A CA2922430C (fr) 2013-09-20 2014-09-18 Diagnostic et traitement du trouble du mouvement
KR1020167009719A KR102259157B1 (ko) 2013-09-20 2014-09-18 운동장애의 진단 및 치료
AU2014324018A AU2014324018B2 (en) 2013-09-20 2014-09-18 Diagnosing and treating movement disorders
US14/914,591 US10231665B2 (en) 2013-09-20 2014-09-18 Diagnosing and treating movement disorders
PCT/CA2014/050893 WO2015039244A1 (fr) 2013-09-20 2014-09-18 Diagnostic et traitement du trouble du mouvement
JP2016543277A JP6498678B2 (ja) 2013-09-20 2014-09-18 運動障害の診断および処置
CN201480063793.XA CN105764416B (zh) 2013-09-20 2014-09-18 诊断和治疗运动障碍
PL14845085T PL3046470T3 (pl) 2013-09-20 2014-09-18 Diagnozowanie i leczenie zaburzeń ruchu
US16/256,313 US11375947B2 (en) 2013-09-20 2019-01-24 Diagnosing and treating movement disorders
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