Patent Application
20210085244
The disclosure pertains to the field of detecting, measuring, or recording devices for diagnostic purposes of the movement of a limb. It is disclosed a device for detecting, measuring or recording the muscle rigidity of a subject's articulation while applying passive limb bending motion, quantitatively evaluating the result of the measurement, especially on cogwheel or gear-like rigidity, for the purpose of identifying a clinically effective dosage regime, in particular of the wrist joints.
Document JP2010193936 discloses an apparatus for measuring the muscle rigidity of a subject while applying passive upper limb bending motion, and quantitatively evaluating the result of measurement especially on the cogwheel or gear-like rigidity, utilizing a motor with an increased motion torque for passively applying the upper-limb bending motion to the subject and a myogenic potential measuring means for measuring the myogenic potential; and a forearm position measuring means for measuring the position of the forearm by a position convertor with a displacement cable. An analysis value is computed on the digital data obtained by downloading biological information on the myogenic potential, and the muscle rigidity is quantitatively evaluated based on the computed data of the analysis value.
The device of JP2010193936 requires both measurement means for the myogenic potential and the forearm position, thus having increased complexity and unwieldiness as the pictured device clearly shows.
Parkinson's Disease (PD) patients often need Deep Brain Stimulation (DBS) surgery when they become intolerant to drugs or these lose efficiency. A stimulation electrode is implanted in the basal ganglia to promote the functional control of the deregulated dopaminergic motor pathways. The stimulation target is defined by medical imaging, followed by electrophysiological inspection for fine electrode position trimming and electrical stimulation tuning. Intra-operative stimulation of the target and the evaluation of wrist rigidity allows to choose the stimulation parameters which best alleviate PD symptoms without side effects. For that, neurologists impose a passive wrist flexion movement and qualitatively describe the perceived decrease in rigidity under different voltages, based on its experience and with subjectivity.
Parkinson's Disease (PD) medicine dosages will normally be different for different patients. Doses higher than what is required to control PD symptoms, increase the risk of side effects like dyskinesia, dizziness, and headache. Also, the number of doses taken each day, the time allowed between doses, and the length of time taking the medicine also depend on the medical problem for which a patient is using the medicine. These may also be different for different patients. There is thus a need for identifying a clinically effective dosage regime. Typically, a physician will increase the dosage amount, increase the number of daily doses, reduce the time allowed between doses, and/or increase the time during which a patient is using the medicine, until a clinically effective dosage regime has been reached, where the dosage regime is sufficient, but not higher than required, to control PD symptoms. The present disclosure provides a reliable method and device evaluation of articulation rigidity, improving upon the inherent subjective clinical evaluation by a physician, which enables the identification of a clinically effective dosage regime while minimizing side effect risks.
It is disclosed a comfortable and wireless wearable motion sensor to classify the wrist rigidity by computing a robust signal descriptor from angular velocity values; building a polynomial mathematical model to classify signals using a quantitative continuous scale. The derived descriptor significantly (p<0.05) distinguished between non-rigid and rigid states and using thresholds or a classification model to discriminate between the two states. The classification model labelled correctly above 80% of the evaluated signals against the blind-agreement of two specialists. Additionally, it is disclosed a methodology to detect cogwheel rigidity from the angular velocity signal with high sensitivity (0.93). The disclosure provides a reliable evaluation of wrist rigidity, improving upon the inherent subjective clinical evaluation while using small, simple, and easy to use motion sensor.
Parkinson's Disease (PD) is a neurodegenerative disorder caused by a reduction in the amount of dopaminergic neurons in the basal ganglia. Dopamine has an inhibitory effect on the excitatory signals to the corticospinal motor control system. The decrease of dopamine transmission between neurons causes the motor pathways to remain in an excited state, thus impairing one's mobility. Cardinal symptoms evidenced by PD patients include bradykinesia (slowness), resting tremor, rigidity, and postural instability.
Currently, there is no cure for PD, although levodopa and dopamine antagonists temporarily relieve the condition. Unfortunately, these drugs lose efficiency over time, leading to a higher incidence and intensity of the manifested symptoms [2], or patients may become intolerant to the drugs. High-frequency Deep Brain Stimulation (DBS) of the basal ganglia structures—such as the subthalamic nucleus (STN) and internal globus pallidus (GPi)—is now the preferred surgical option to alleviate PD symptoms. It has been reported to reduce tremor, bradykinesia and, specially, rigidity better than medication alone. The procedure consists in the implantation of a stimulation electrode that promotes the functional inhibition of the excited motor control pathways, resembling the effect of dopamine on the basal ganglia structures.
The stereotactic target of stimulation is defined based on pre-operative medical imaging. Then, the best stimulation site is found by electrophysiological exploration using a tetrapolar electrode. The four contacts on the lead are subsequently inspected while varying the stimulation parameters and testing symptoms and side effects to determine the final placement of the electrode. The wrist rigidity is a reliable feature since it can be measured passively by a trained neurologist and scored using a semi-quantitative scale [3]. Such rigidity hampers the wrist flexion movement, inducing jerky movements of the wrist joint. This resembles the action of a cogwheel [4] and is a relevant clinical feature. This evaluation is often biased by the experience, perception and subjective scale defined by each physician [5], creating the need for an objective and quantitative evaluation methodology.
The existing technology requires complex acquisition setups and has been used to prove the existence of correlation between kinematic measures and UPDRS clinical scores. However, such analysis is done a posteriori and the complexity and invasiveness of the existing systems make them unpractical for intra-OR DBS procedures or for adjusting a dosage regime. A practical, simple, and precise system to evaluate wrist rigidity under specific stimulation parameters during DBS surgery, or during adjustment of a dosage regime, and a method to detect cogwheel rigidity from angular velocity data were designed. Such solution significantly reduces the degree of subjectivity of the evaluation and greatly helps in the determination of the optimal dosage regime or stimulation setting.
PD patient's rigidity is commonly described using the Unified Parkinsons Disease Rating Scale (UPDRS). For the case of wrist rigidity, the neurologist is asked to grade the passive wrist flexion and extension resistance from absent (0) to severe (4). Consequently, this discrete scale is highly subjective, as mentioned before.
The introduction of motion sensors to measure wrist rigidity in implanted patients is fairly new. The first experimental demonstration of the effectiveness of STN DBS stimulation occurred in 2007 [2]. In this study, the patients were asked to manipulate a lightweight bar in both on and off stimulation states. They later integrated the inertial torque over consecutive angles of the wrist to calculate the work applied, showing statistical significance between both states.
Following that study, [6] objectified muscle rigidity via surface electromyography (EMG) recordings of the biceps and the triceps brachii, with high correlation between measures and UPDRS scores of specialists. More recently, [7] further explored the premises arose by [2] and observed a significant decrease in wrist rigidity under high-frequency DBS while manipulating an aluminium bar. Angular displacement was assessed using a goniometer across the wrist and the force was measured by a strain gauge mounted on the bar. At the therapeutic frequency of stimulation, 130 Hz, increased mobility was shown. In 2014, [5] evaluated the wrist rigidity during intra-operative DBS by measuring several biomechanical properties. High correlation rates were found between the viscous damping and UPDRS clinical scores.
It is disclosed a system comprising a small-sized wearable motion sensor and custom-made software to visualize the signal and evaluate wrist rigidity during DBS surgery or during dosage regime adjustment, as shown in
According to an embodiment, to guarantee data invariance with respect to hand rotation and position, only gyroscope data, acquired with respect to the device coordinate system was considered, according to an embodiment. It may also be possible to convert accelerometer or magnetometer data, or combinations thereof with gyroscope data, to obtain a signal of angular velocity, though with added complexity.
The angular velocity signal was obtained as follows, where the number 32767 can take any value between −32768 and 32767, e.g. depending on the specific sensor resolution:
Where gy stands for the raw gyroscope Y-axis data. The signal was filtered using a 4-sample moving average filter to remove eventual tremor and then kept only samples corresponding to wrist flexion movements. For that, the absolute value of the negative arcades of w was taken, discarding the remainder of the signal. Rigidity can be perceived as a resisting force or torque that limits the velocity, range, and smoothness of the imposed wrist flexion movement. Therefore, a stimulation setting that diminishes rigidity yields higher angular velocities and smoother signals.
It is disclosed a signal descriptor, i.e. a non-rigidity index, from quantitative kinematic measures, as show in
ϕ=√{square root over (μωμP)} (2)
where μω stands for the average angular velocity and μP for the average peak value. Absolute peaks were calculated as the highest values between two valleys of the signal, within a margin of 0.2° s−1 according to an embodiment.
There is a direct correlation between a low rigidity and higher values of μP. However, that is not enough for an accurate description, since signals with widely different shapes can have peaks of similar height. Elongated signal arcades, few peaks in a certain period of time or unexpected plateaus during the flexion movement, even in signals with high amplitude, correspond to some residual rigidity and must be taken in consideration. Such information is yielded by μω since the average value of the signal decreases for non-smooth and non-sharpen signals. The squared root notches back ϕ into the signal range and establishes an operating point whose value is between the two kinematic measures.
The descriptor was expected to significantly distinguish between the stimulation settings that alleviate the patients' condition and those who do not. Therefore, the training dataset was clustered into the specified classes and computed the values of ϕ for each signal. Jarque-Bera tests [8] confirmed the normality of the data and descriptive power was assessed using two-tailed t-tests.
The cogwheel rigidity of the wrist joint creates artefacts on the angular velocity signal, observable in
where h stands for the distance between a valley and the midpoint between the flanking peaks, Δt is the time span of the triangle, A its area and λ the threshold value for the detection of a cogwheel artefact. We optimized λ and assessed the detection accuracy from a ROC curve built following what is described in [9]: 30 randomly chosen training signals, whose ground-truth was previously agreed between observers.
The rigidity during passive wrist flexion was labelled by specialists following a discrete decimal scale ranging between 0 and 80 percent. Higher label values correspond to lower perceived wrist rigidity. Mathworks Matlab R2013a was used to analyse the 48 signals of the training set. Following this, the polynomial mathematical model that best approximates the perceived wrist rigidity as a function of the mean value of the signal descriptor ϕ for each rigidity scale was built. Approximations of higher degrees can lead to overfitting and be less responsive to widely different incoming signals. Moreover, although this problem could be addressed using standard machine learning techniques, they require heavy computation and would limit a future implementation with local signal processing. Training error was assessed as the Leave-One-Out Error.
According to an embodiment, signal shape descriptors and other kinematic properties, such as quaternions, are integrated into this classification model to guarantee higher robustness and discriminative power. According to a further embodiment, wrist rigidity is compared under each stimulation setting with the baseline rigidity. This allows to estimate how each setting alleviates wrist rigidity, diminishing the influence of inter-subject variability in rigidity. According to a further embodiment, this device and method can be used in other PD related medical procedures, such as tremor detection and characterization or levodopa tests.
The evaluation of wrist rigidity during DBS surgery with reliability, with clinical relevance and real-time feedback to neurologists was mimicked. For that, a comfortable, simple, and custom-made wearable motion sensor system was designed, capable of evaluating wrist rigidity under different stimulation settings using only angular velocity values computed from gyroscope data. It was correctly classified over 80% of the evaluated signals using a polynomial mathematical model and deriving a signal descriptor based on simple kinematic measures. The present device performance is not influenced by the possible variability of the imposed wrist flexion movement, and invariant hand position and orientation.
According to an embodiment, signal processing strategies to evaluate signal shape and smoothness are used, as well as incorporating quaternion information. The estimation of biomechanical properties from the acquired signals can be of major help to completely describe rigidity and provide fiducial information for the success of DBS or dosage regime adjustment. Additionally, according to an embodiment it is compared each signal to be evaluated with the baseline rigidity characteristics to accurately estimate the diminishing in perceived rigidity and monitor the alleviation of the condition.
It is disclosed an articulation rigidity assessment device for assessing the rigidity of an articulation when a bending motion is imposed to a limb of said articulation around a predetermined rotation axis of the articulation, said device comprising: a one-axis angular velocity sensor for attaching to said limb such that the axis of measurement is parallel to the axis of rotation of the imposed bending motion; a data processor configured (i.e. programmed) to process the signal of the angular velocity sensor and to distinguish between non-rigid and rigid states of the articulation using the processed angular velocity signal.
An embodiment comprises a skin-contacting patch for applying to the limb of the patient wherein the one-axis angular velocity sensor is attached to said skin-contacting patch.
In an embodiment, the articulation is a wrist articulation of the patient and the limb is the respective hand. In an embodiment, the axis of rotation of the imposed bending motion is the axis of rotation of extension-flexion of the wrist articulation.
In an embodiment, the skin-contacting patch is a skin-contacting patch for applying to the palm or back of the hand.
In an embodiment, the data processor is configured to calculate a non-rigidity index by the square root of the multiplication of the average of the angular velocity signal by the average peak value of the angular velocity signal.
In an embodiment, the data processor is configured to calculate a non-rigidity index for a cycle of the imposed bending motion by the square root of the multiplication of the average of the angular velocity signal by the average peak value of the angular velocity signal.
In an embodiment, the data processor is configured to distinguish between non-rigid and rigid states by detecting a non-rigid state if the calculated non-rigidity index is above a predetermined threshold.
In an embodiment, the data processor is configured to calculate a quantitative continuous scale of the rigidity of the articulation using a polynomial function whose input is the non-rigidity index.
In an embodiment, the data processor is configured to detect cogwheel rigidity of the articulation by detecting non-minima valleys bordered by two peaks of the non-rigidity index along a cycle of the imposed bending motion. In particular, the data processor is configured such that the clinically effective dose is identified as having been administered as a function of the output, only if cogwheel rigidity is not detected.
In an embodiment, the data processor is configured to detect cogwheel rigidity of the articulation by detecting non-minima valleys bordered by two peaks of the non-rigidity index by:
extracting all the peaks and valleys of the index signal along time;
drawing each possible triangle between a valley and the two peaks enclosing it; determine if the following calculation is true:
wherein h is the distance between the valley and the midpoint between the two peaks, Δt is the time span of the triangle formed by the valley and the two peaks, A is the triangle area and λ is a predetermined threshold value for the detection of cogwheel rigidity.
In an embodiment, the one-axis angular velocity sensor is a one-axis gyroscope.
An embodiment comprises a three-axis gyroscope, wherein the one-axis angular velocity sensor is a virtual sensor, and the data processor is configured to calculate the equivalent one-axis angular velocity virtual sensor signal from the signals of the three-axis gyroscope.
An embodiment comprises an accelerometer-gyroscope-magnetometer, wherein the one-axis angular velocity sensor is a virtual sensor, and wherein the data processor is configured to calculate the equivalent one-axis angular velocity virtual sensor signal from the signals of the accelerometer-gyroscope-magnetometer.
In an embodiment, the data processor is configured to pre-process the angular velocity sensor signal by filtering the angular velocity sensor signal with a moving average of the absolute value of the signal.
In an embodiment, the skin-contacting patch is an adhesive patch.
It is also described a fingerless glove wherein the skin-contacting patch is an integral part of said glove.
It is also described an elastic textile band wherein the skin-contacting patch is an integral textile part of said band.
It is also described the use of the device for assisting in deep brain stimulation surgery of a patient.
An embodiment comprises a display attached to the data processor, wherein the data processor is connected wirelessly to the angular velocity sensor, and the data processor is arranged to output a real-time feedback of the non-rigidity index through said display.
An embodiment comprises a display connected wirelessly to the data processor, wherein the data processor is electrically connected to the angular velocity sensor and the data processor is attached to the skin-contacting patch, and the data processor is arranged to output a real-time feedback of indication of the non-rigidity index through said display.
The following figures provide preferred embodiments for the present disclosure and should not be seen as limiting the scope of the disclosure.
According to an embodiment, the designed hardware comprises a Texas Instruments Microcontroller (MCU), a Invensense's ITG-3200 gyroscope (range of ±2000°/s and 6.5 mA operating current), a KXTF9-1026 Kionix accelerometer (with ranges 2g, 4g and 8g) and a Honeywell's HMC5883L magnetometer (with compass heading accuracy of 1° to 2°). The MCU gathers data from the sensors at 100 Hz, building packages that are transmitted via Bluetooth to a synced device at a 42 Hz rate, and can compute quaternions in real time.
The sensor signal was acquired and processed using National Instruments Labview 2014, in an Intel Core i7-4600U CPU @ 2.70 GHz computer, according to an embodiment.
Six patients (Mean Age: 67 years; 3 male and 3 female) subjected to bilateral DBS surgery were tested and a total of 48 signals was acquired to train a rigidity classification model. Medication was withdrawn for 12 h prior to the procedure and local anaesthetic was administered. The DBS electrodes were inserted in the STN stereotactic target and electrophysiological inspection was performed to determine the definitive stimulation site. Stimulation frequency was fixed at 130 Hz and both voltage and electrode position were varied, while searching for the greatest reduction in wrist rigidity during passive wrist flexion without secondary effects. The optimal setting was agreed between two experienced physicians. The patients wore the developed system during the whole procedure for signal recording purposes. Additional 4 patients (Mean Age: 64 years; 2 male and 2 female) had their rigidity classified under variable stimulation settings by the present disclosure. Patients were submitted to the same medical procedure as the training group. Signal classification (156 signals as total) performance was evaluated against the agreement of two expert physicians: classifications were accepted if contained inside a 5% margin with respect to the clinical score.
It is disclosed a device and method to quantitatively evaluate wrist rigidity and help on the determination of the optimal stimulation setting. The statistical analysis results summarized in Table I demonstrated the capability of the selected kinematic measures ϕ to distinguish between rigid and non-rigid states. Furthermore, it was observed that ϕ has a slightly more discriminative (pϕ=0.027) than its counterparts (pμω=0.034 and pμP=0.029). This confirms the present disclosure in that the combination of both features describes well the correlation between the signal amplitude and shape while maintaining the simplicity.
The derived mathematical model for rigidity classification, depicted in
Nevertheless, 131 out of 156 classifications performed by the present disclosure did not differ from the agreement between two expert physicians, corresponding to an acceptance rate above 80%. Major limitations were found on the evaluation of signals corresponding to intermediate rigidity states, whose correlation with the classification model was lower (see
Additional biomechanical properties can also be explored in this context, such as work and impulse, both derived from resistive torque. However, these quantities are often dependent on the speed of the imposed movement which cannot be guaranteed by physicians.
In fact, such variability in the imposed velocity caused by the imposed movement by the physician can help to better perceive the wrist rigidity. A constant velocity would only be ensured by using a mechanical system attached to the limb, increasing the invasiveness and complexity of the procedure.
Regarding the detection of cogwheel rigidity, the ROC Curve on
Levodopa is an amino acid precursor of dopamine with antiparkinsonian properties. Levodopa is a prodrug that is converted to dopamine by DOPA decarboxylase and can cross the blood-brain barrier. Two patients (male aged 47 years and female aged 61 years) were subjected to a Levodopa level medication test where an experienced neurologist evaluates the subjective Unified PD Rating Scale (UPDRS) [11] motor semi-quantitative classification for Rigidity & Rest Tremor (0 to 4) for a baseline (no levodopa) and in steps of increasing levodopa dosages until a UPDRS of 0 is achieved. This is the dosage as prescribed to the patient. At this dosage, wrist rigidity was evaluated as presently disclosed. As described above, higher index values correspond to lower perceived wrist rigidities. See also
The term “comprising” whenever used in this document is intended to indicate the presence of stated features, integers, steps, components, but not to preclude the presence or addition of one or more other features, integers, steps, components or groups thereof. It is to be appreciated that certain embodiments of the disclosure as described herein may be incorporated as code (e.g., a software algorithm or program) residing in firmware and/or on computer useable medium having control logic for enabling execution on a computer system having a computer processor, such as any of the servers described herein. Such a computer system typically includes memory storage configured to provide output from execution of the code which configures a processor in accordance with the execution. The code can be arranged as firmware or software. If implemented using modules, the code can comprise a single module or a plurality of modules that operate in cooperation with one another to configure the machine in which it is executed to perform the associated functions, as described herein. It is also disclosed a non-transitory storage media comprising computer program instructions for implementing a method as disclosed, the computer program instructions including instructions which, when executed by a processor, cause the processor to carry out one of the disclosed methods.
The disclosure should not be seen in any way restricted to the embodiments described and a person with ordinary skill in the art will foresee many possibilities to modifications thereof. The embodiments described above are combinable. The following claims further set out particular embodiments of the disclosure.
| Number | Date | Country | Kind |
|---|---|---|---|
| 108366 | Apr 2015 | PT | national |
This application is a continuation-in-part application of U.S. patent application Ser. No. 15/566,436, filed Oct. 13, 2017, (now U.S. Pat. No. 10,856,778) which is hereby incorporated by reference as if set forth in its entirety herein.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15566436 | Oct 2017 | US |
| Child | 17115226 | US |
