The present invention relates to assessing a neural state from neural potentials, and in particular relates to obtaining a recording of a neural potential arising on neural tissue, and monitoring for an anomalous profile of the recording, in order to assess the existence, state or progress of a neural disease.
Neuropathic pain arises from damage or disease affecting the somatosensory system, and may result from disorders of the peripheral nervous system or the central nervous system. For example, complex regional pain syndrome (CRPS) is a severe type of pain disorder.
There is no known single pathognomonic symptom or sign of neuropathic disease. Consequently, it is difficult to diagnose neuropathic disease and to monitor the progress of neuropathic disease. No conclusive objective diagnostic exists for neuropathic pain, and clinicians must rely largely on a subjective clinical observation of the patient's responses. Neuropathic pain is also difficult to treat and often responds poorly to standard pain treatments.
A range of medications for treating neuropathic pain exist, including gabapentin for example. Careful documentation and appropriate monitoring of treatment are important for the safe and effective use of such medications, however this is difficult to achieve due to the difficulty of determining the disease state or monitoring the progress of the disease or symptoms. Advanced therapies for treating neuropathic pain include spinal cord stimulation.
Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is solely for the purpose of providing a context for the present invention. It is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed before the priority date of each claim of this application.
Throughout this specification the word “comprise”, or variations such as “comprises” or “comprising”, will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.
In this specification, a statement that an element may be “at least one of” a list of options is to be understood that the element may be any one of the listed options, or may be any combination of two or more of the listed options.
According to a first aspect the present invention provides a method of assessing a neural state of a subject, the method comprising:
A method for determining whether a human patient has neuropathic disease, comprising:
A non-transitory computer readable medium for assessing a neural state of a subject, comprising instructions which, when executed by one or more processors, causes performance of the following:
The detection of irregularities or anomalies in the recorded response may comprise any one or more of:
Some embodiments may determine whether more than three peaks exist in the recorded compound action potential by measuring an amplitude or power of the recorded compound action potential in a time window positioned after cessation of a normal response. The amplitude or power of the recorded compound action potential in such a time window can be used to assess the presence or absence of an abnormal response arising later than a normal P2 peak. Additionally or alternatively, a matched filter or other signal processing means may be used to detect the presence of an extra lobe in the recorded compound action potential.
Some embodiments of the present invention thus recognise that when considering a recorded compound action potential (CAP) obtained from a person suffering from an altered neural state such as CRPS, rather than the CAP taking a typical three lobed profile, lobe deformation or additional lobes referred to herein as doublets can be observed to arise in the ECAP. Moreover, the degree of lobe deformation and/or the relative size of the additional lobes appearing in the response can he measured, in order to give not only a binary diagnosis but also a quantitative measure of the severity of the disease suffered by the person. Absence of such response profile anomalies may be used to eliminate some diseases from a diagnosis for the person. Repeated assessment of the recorded response profile from time to time, for example throughout administration of a therapy, may be used to assess disease state, disease progress, and therapy efficacy, and may be used to guide therapy modifications and optimisation over time. Therapy modifications may include modifications of dosage of a medicament and/or modification of a stimulus regime applied by a spinal column stimulator.
Accordingly, the present invention recognises that monitoring for the occurrence and severity of anomalies such as doublets in the recorded response profile gives a diagnostic for neuropathic pain or neural damage or in general any neural disease which gives rise to atypical neural response profiles.
Notably, some embodiments of the present invention further recognise that when application of a stimulus to a first neural site gives rise to anomalies in a recorded neural response profile, application of the same stimulus to an alternative neural site might give rise to a recorded neural response without abnormalities. Such embodiments may thus provide for identifying a locus of neuropathic pain.
The method of the present invention may in some embodiments be performed intra-operatively for example to effect electrode array implantation site optimisation. The method of the present invention may additionally or alternatively be performed during an implant programming stage in order to optimise electrode selection to a site at which a locus of neuropathic pain is identified.
The invention may further provide for intra-operative monitoring of the response profile during a sympathectomy procedure, in order to provide an intra-operative progressive indication of efficacy of the sympathectomy.
According to a further aspect the present invention provides a method of treating a neural disease, the method comprising:
The compound action potential may arise from deliberate stimulation, whether peripheral stimulation or direct spinal column stimulation, for example.
An example of the invention will now be described with reference to the accompanying drawings, in which:
Module controller 116 has an associated memory 118 storing patient settings 120, control programs 122 and the like. Controller 116 controls a pulse generator 124 to generate stimuli in the form of current pulses in accordance with the patient settings 120 and control programs 122. Electrode selection module 126 switches the generated pulses to the appropriate electrode(s) of electrode array 150, for delivery of the current pulse to the tissue surrounding the selected electrode(s). Measurement circuitry 128 is configured to capture measurements of neural responses sensed at sense electrode(s) of the electrode array as selected by electrode selection module 126.
Delivery of an appropriate stimulus to the nerve 180 evokes a neural response comprising a compound action potential which will propagate along the nerve 180 as illustrated, for therapeutic purposes which in the case of a spinal cord stimulator for chronic pain might be to create paraesthesia at a desired location. To this end the stimulus electrodes are used to deliver stimuli at 30 Hz. To fit the device, a clinician applies stimuli which produce a sensation that is experienced by the user as a paraesthesia. When the paraesthesia is in a location and of a size which is congruent with the area of the user's body affected by pain, the clinician nominates that configuration for ongoing use.
The device 100 is further configured to sense the existence and intensity of compound action potentials (CAPs) propagating along nerve 180, whether such CAPs are evoked by the stimulus from electrodes 2 and 4, or otherwise evoked. To this end, any electrodes of the array 150 may be selected by the electrode selection module 126 to serve as measurement electrode 6 and measurement reference electrode 8. Signals sensed by the measurement electrodes 6 and 8 are passed to measurement circuitry 128, which for example may operate in accordance with the teachings of International Patent Application Publication No. WO2012155183 by the present applicant, the content of which is incorporated herein by reference.
The CAP profile takes a typical form and can be characterised by any suitable parameter(s) of which some are indicated in
The present invention thus recognises that the shape or profile of the compound action potential reflects changes in the ion channel characteristics as a result of pathological or natural change.
Comparison of ECAP measurements from the dorsal column of a number of different human subjects was undertaken in order to identify systematic differences which relate to either genetic or pathological differences between subjects. Measurements of dorsal column evoked compound action potentials show distinct differences between the ECAP shapes measured at different electrodes along the array.
In contrast,
To explore the question of ectopic discharge, the refractory period was investigated using the “masker probe” techniques set forth in International Patent Application Publication No. WO2012/155189, the contents of which are incorporated herein by reference.
There appears to be little consistency between the N1 latency and the appearance of the double response so N1 latency may not be a suitable parameter for diagnosing neural state.
Some embodiments may provide for repeated assessment of the recorded response profile from time to time, for example throughout administration of a therapy, in order to assess disease state, disease progress, and therapy efficacy, and may be used to guide therapy modifications and optimisation over time. Therapy modifications may include modifications of dosage of a medicament and/or modification of a stimulus regime applied by a spinal column stimulator.
It will he appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the spirit or scope of the invention as broadly described. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.
Number | Date | Country | Kind |
---|---|---|---|
2014901110 | Mar 2014 | AU | national |
This application is a continuation of U.S. patent application Ser. No. 15/129,407 entitled “Assessing Neural State from Action Potentials”, filed Sep. 26, 2016 which is a national stage of PCT Application No. PCT/AU2015/050135 filed Mar. 27, 2015 which claims the benefit of Australian Provisional Patent Application No. 2014901110 filed Mar. 28, 2014, the disclosures of which are incorporated herein by reference in their entireties.
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20220287620 A1 | Sep 2022 | US |
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Parent | 15129407 | US | |
Child | 17804846 | US |