WO2018033732A1 - Vérification de l'emplacement d'implantation d'un fil de stimulation cérébrale profonde (scp) - Google Patents

Vérification de l'emplacement d'implantation d'un fil de stimulation cérébrale profonde (scp) Download PDF

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Publication number
WO2018033732A1
WO2018033732A1 PCT/GB2017/052418 GB2017052418W WO2018033732A1 WO 2018033732 A1 WO2018033732 A1 WO 2018033732A1 GB 2017052418 W GB2017052418 W GB 2017052418W WO 2018033732 A1 WO2018033732 A1 WO 2018033732A1
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dbs
electrodes
lead
distance
target
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PCT/GB2017/052418
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English (en)
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Binith CHEERAN
Pedro REBELO
Andrea Guerra
Andreas PROTOPAPAS
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Oxford University Innovation Limited
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526—Head electrodes
    • A61N1/0529—Electrodes for brain stimulation
    • A61N1/0534—Electrodes for deep brain stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A61B5/065—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6868—Brain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6886—Monitoring or controlling distance between sensor and tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36067—Movement disorders, e.g. tremor or Parkinson disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36135—Control systems using physiological parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/055—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves  involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
    • A61B5/4076—Diagnosing or monitoring particular conditions of the nervous system
    • A61B5/4082—Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
    • A61B5/4076—Diagnosing or monitoring particular conditions of the nervous system
    • A61B5/4094—Diagnosing or monitoring seizure diseases, e.g. epilepsy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods

Definitions

  • the present invention relates to a method of and system for assessing the suitability of a target for deep brain stimulation (DBS) and/or the suitability of the implanted position of a DBS lead.
  • the present invention relates to a method of and system for checking the location of implantation of a DBS lead.
  • the present invention also relates to a method of performing deep brain stimulation (DBS).
  • DBS deep brain stimulation
  • DBS is a non-destructive and reversible type of surgery. This becomes important where it transpires that the electrodes have been implanted incorrectly, at the wrong position in the brain, causing undesirable, possibly unpleasant, side effects. Ceasing the pulses, and therefore the stimulation, also ceases the (potentially adverse) effects that the stimulation has been providing. However, if the neurological condition still needs to be treated, correcting how the stimulation is applied, and possibly repositioning the implanted electrodes, can be difficult. It is clearly desirable to avoid repeat attempts at implantation due to the risks associated with brain lead insertion.
  • the electrodes are typically located along and at or near the end of a lead (or probe) that is implanted into the patient's brain. Assuming the lead and electrode(s) are positioned correctly, pulses can be used to stimulate nearby neurons.
  • Figure 1 shows a frequency-time log power spectrum where the dark peaks around 22 Hz are representative of high or over-activity in the brain. DBS is applied at a time interval, as shown by the bars on the time axis and it can be seen that, where DBS is utilized, the activity reduces. I.e. this demonstrates the advantageous effect DBS can have on the brain of a person suffering with a neurological condition. For example, DBS is believed to help to modulate the oscillatory activity which occurs between the cortex and the basal ganglia.
  • High frequency DBS is believed to suppress the excess activity at low frequencies e.g. between about 12 and 28 Hz (the beta frequency band) that occurs in Parkinson's Disease.
  • the signal attenuates with distance from the source. Suppressing the signal, using DBS, improves the symptoms of Parkinson's Disease, implying that implanting an electrode array spanning the source of this signal would be the most efficient way to suppress the symptoms.
  • Different sites in the brain will need to be targeted, depending on the condition and/or symptoms to be treated.
  • the subthalamic nucleus (STN) or the globus pallidus interna (GPi) are commonly targeted.
  • STN subthalamic nucleus
  • GPi globus pallidus interna
  • DBS lead that is implanted in the brain is activated, it emits an electric field into the surrounding area which, if positioned well, will stimulate the correct part of the brain and provide beneficial effects.
  • even correct positioning of the DBS lead, and especially incorrect positioning of the lead can provide stimulation to parts of the brain that should not be stimulated. That can lead to adverse effects on the patient.
  • DBS lead is implanted more than 1.5mm away from the target implantation location, DBS applied will be ineffective, however, for the reasons discussed herein, accurately locating a DBS lead is difficult.
  • a DBS lead 10 e.g. as shown in Figure 2, comprises a number of ring electrodes 12 that extend the entire circumference of a cylindrical lead. Electrical connections 14 provide for conveying the generated pulses to one or more of the electrodes.
  • the electrodes emit stimulation current I in all directions, as depicted by the arrows.
  • Split or segmented or non-circumferential electrode leads have also been developed, for example.
  • electrode portions 16 are provided around the periphery of the lead. When activated, the electric field produced is directional, rather than annular, dependent upon the size and positions of the electrode portions. This can help avoid stimulating areas of the brain that should not be stimulated (because that would cause unwanted side effects). It is possible to selectively activate one or more of the electrode portions.
  • MRI magnetic resonance imaging
  • CT computerized tomography
  • Stereotaxy is a form of surgery utilizing a 3D coordinate system to locate a target inside the brain for DBS.
  • CT scans involve X-ray imaging
  • MRI scans use magnetic fields and radio frequency pulses to produce an image of the brain.
  • the STN has three major functional divisions, of which motor control is one.
  • the part of the STN sub-serving motor control needs to be implanted for symptomatic benefit. Stimulation through a contact in the part of the STN sub-serving limbic function can induce neuropsychiatric side-effects. However, the limbic and motor areas of the STN are indistinguishable on routine clinical scans. In the treatment of Parkinson's Disease, the STN or GPi is often targeted, but imaging using MRI or CT alone is insufficient to accurately locate the motor areas of within these brain structures to target with DBS - i.e. precise co-ordinates within the brain where DBS should be applied.
  • micro-electrodes is often used in the determination phase. For example, between 3 and 7 multiple small probes can be inserted into the brain to assess multiple trajectories around the initial target selected using imaging and/ or stereotactic co-ordinates. These micro-electrodes can be used to "scope out" what the best trajectory might be and then a thicker DBS probe can be inserted along one of those trajectories in order to actually provide the DBS to the patient. By testing a higher number of possible trajectories, better results can be achieved compared with MRI or CT scanning alone.
  • a Microdrive is used to place the DBS lead at a particular depth, typically such that the middle of the electrode array is at the target.
  • inserting multiple leads into the brain increases the risk of bleeding and insertion into an area where insertion/stimulation is not required.
  • the process is time- consuming and prone to error in inexperienced hands.
  • fewer centres use micro-electrode recordings compared to when DBS was first introduced in the modern era.
  • a stereotactic frame is used. If the frame develops a fault e.g. due to wear and tear, or because it develops a slight twist in the structure etc., this can lead to large errors (e.g. up to 3mm) in determining the DBS implantation location. Incorrect implantation can lead to stimulation of other parts of the brain and corresponding unpleasant side effects.
  • a method of checking the location of implantation of a deep brain stimulation (DBS) lead comprising a plurality of electrodes comprises deriving a value representative of an electrophysiological signal obtained from two or more of the electrodes.
  • the method may further comprise comparing the derived values against the distance of the electrode(s) from an intended stereotactic target location.
  • the method may further comprise calculating a mathematical function representative of how the signal varies with distance. On the basis of the calculated mathematical function, the method may further comprise determining the proximity of an implanted DBS lead to a target implantation position.
  • the plurality of electrodes is typically distributed over or across a DBS lead. It may be desirable for the centremost electrode(s) of the plurality to be within the vicinity of the target location, so that the array spans an intended target.
  • the present invention provides a way to check the quality of placement of an implanted DBS lead by mathematically processing signals received at the electrodes and without the need for further invasive techniques.
  • calculating the mathematical function comprises fitting the derived values against distance using a straight line fit or a curve.
  • Calculating the mathematical function may comprise fitting the derived values against distance using a mathematical transformation on the derived values such as taking a natural logarithm.
  • the method may further comprise determining whether there is a positive or negative correlation between the derived values and the distance.
  • the method may further comprise comparing the correlation between the derived values and the distance, for a particular electrode or DBS lead, over time and determining whether the DBS lead is still implanted at a correct or optimal position.
  • comparing the derived values and the distance may comprise plotting the derived values against distance on a graph.
  • the method may further comprise displaying or outputting one or more of the derived values, distance or fit, or parameters relating thereto.
  • deriving the values representative of the LFP signal comprises deriving the power.
  • detecting an electrophysiological signal comprises detecting a local field potential (LFP).
  • LFP signals in the beta oscillation range (approximately 12-28Hz) emitted by the subthalamic nucleus (STN) of a person's brain are detected.
  • STN subthalamic nucleus
  • other neurophysiological signals could be detected e.g. seizure activity.
  • a system for checking the location of implantation of a deep brain stimulation (DBS) lead comprising a plurality of electrodes.
  • DBS deep brain stimulation
  • the system may comprise a deep brain stimulation (DBS) lead comprising a plurality of electrodes, the electrodes being operational to emit a stimulation pulse and/or to detect an electrophysiological signal.
  • the system may also comprise a pulse generator operational to command one or more of the electrodes to emit a stimulation pulse and/or to detect an electrophysiological signal.
  • a remote control module operational to program the pulse generator to command one or more of the electrodes may also be provided.
  • Software may also be provided, configured to run at the remote control module or other processor to perform the method of any of the first aspect.
  • the DBS lead is of circular cross section and the electrodes are distributed around the circumference thereof in a pattern and/or in bands e.g. longitudinally separated along the DBS lead.
  • the pulse generator and remote control module are configured for wireless communication and, optionally or preferably, by radio. Other suitable forms of communication may also/instead be used.
  • the same or different electrodes or contacts may be used for sensing and for stimulation.
  • the electrodes may be configured to detect local field potentials (LFPs).
  • the electrodes are configured to detect local field potentials (LFPs) in the beta oscillation range (approximately 12-28Hz) emitted by the subthalamic nucleus (STN) of a person's brain.
  • the electrodes may be configured to detect other signals and/or at other frequencies.
  • a method of performing deep brain stimulation may comprise inserting a DBS lead into a brain or using a DBS lead inserted into a brain.
  • the DBS lead may comprise a plurality of electrodes.
  • the method may also comprise coupling the DBS lead to a remote control module.
  • the method may further comprise performing the method of the first aspect.
  • the method may further comprise using the control module to generate electrical stimulation signals at one or more of the electrodes.
  • aspects and embodiments of the invention may be implemented on a computer.
  • a computer program which when run on a computer, causes the computer to perform any method disclosed herein.
  • the computer program may be a software implementation, and the computer may be considered as any appropriate hardware, including a digital signal processor, a microcontroller, and an implementation in read only memory (ROM), erasable programmable read only memory (EPROM) or electronically erasable programmable read only memory (EEPROM), as non-limiting examples.
  • the software implementation may be an assembly program.
  • the computer program may be provided on a computer readable medium, which may be a physical computer readable medium, such as a disc or a memory device, or may be embodied as a transient signal.
  • a transient signal may be a network download, including an internet download.
  • aspects and embodiments of the invention involve comparing the derived values against the distance of the electrode(s) from an intended stereotactic target location (e.g. by plotting the values), calculating a mathematical function representative of how the signal varies with distance (e.g. taking a logarithm of the power values) and using that to determine the proximity of an implanted DBS lead to a target implantation position (e.g. by determining whether the fit gives a positive or negative slope).
  • aspects and embodiments of the invention utilise the LFP signals to assess the quality of the target "X" selected using imaging and/or a surgical atlas. Effectively, aspects and embodiments of the invention enable a surgeon to be able to determine whether "X" is good enough, based on the position of implanted DBS electrodes and recording physiological signals such as LFPs using the electrodes. I.e. after a DBS lead is inserted into a patient - e.g. following the MRI and atlas insertion location determination - is it in a good place, or should it be somewhere else?
  • the present invention enables determination of any significant discrepancies between an imaging based target implanted with a DBS electrode and the optimal physiological target, without the need for additional invasive probes.
  • the present invention can indicate when a better physiological target may be available, using electrode position intra/post-operative imaging and physiological signals recorded directly through the DBS electrode. No additional invasive recording is required.
  • the method uses recordings from the DBS lead itself to assess DBS lead placement intra-operatively.
  • microelectrodes it is known in the art to use microelectrodes to identify the target location. It is also possible to get a measure of the quality of the identified target location by determining the length (in mm) of the passage of the microelectrode through the target area using a microdrive.
  • LFP measurements there is no comparable technique for LFP measurements using a macroelectrode. This is because macroelectrodes operate on a signal that summates spatially and as such is prone to volume conduction and an accurate length measurement is not possible due to the spread of the signal.
  • the power of a signal recorded by a macroelectrode alone is not an indicator of implantation in an optimal target, as this can vary with location, disease state, severity and duration.
  • Figure 3 is a schematic view of a system according to an embodiment of the invention
  • Figure 4 is a schematic view of a DBS lead implanted near a stereotactic target of a patient's brain
  • Figure 5(a) is a schematic view of a DBS lead implanted near a stereotactic target of a patient's brain;
  • Figure 5(b) is a schematic view of a DBS lead implanted near a stereotactic target of a patient's brain;
  • Figure 6 is a graph showing signal power strength measured at several DBS leads in different patients against distance of the electrodes from a stereotactic target
  • Figure 7 is an illustration of Figure 6 for an individual patient
  • Figure 8 illustrates mathematically fitting of data obtained from several patients
  • Figure 9 is a plot showing a reconstruction of DBS leads in 3D stereotactic space, relative to an intended target.
  • a system 100 operable for applying deep brain stimulation (DBS) to a patient and for use in determining the suitability of a target for deep brain stimulation (DBS) and/or the suitability of the implanted position of a DBS lead.
  • the system comprises two DBS leads 102, 104.
  • the DBS leads 102, 104 are implantable into a patient's brain in accordance with conventional techniques (or other techniques yet to be developed). It will be appreciated that it is not necessary to have two DBS leads - sometimes a single lead can be used for unilateral stimulation; other times multiple leads are used e.g. for treating pain or epilepsy.
  • Each lead comprises a plurality of electrodes 106, 108.
  • each lead 102, 104 has eight segmented electrodes 106, 108 respectively, but it will be appreciated that any number of electrodes, or ring electrodes, can be provided.
  • Each electrode 106, 108 is electrically connected to an implantable pulse generator 1 10. This is preferably achieved via one or more wires 1 12, provided internally of the leads 106, 108. The wires run inside the leads 102, 104 to connect to each electrode 106, 108.
  • the pulse generator 1 10 is typically implanted in a person's body e.g. in their chest, but this need not be the case e.g. during testing of the system.
  • the pulse generator is operable to provide electrical stimulation pulses with parameters (e.g. duration, amplitude, frequency) that can be set dependent upon requirements.
  • the pulse generator 1 10 can communicate with a remote control module 1 12, which is not implanted in the patient's body.
  • a suitable communication link may be radio, but other means of wireless communication are also envisaged.
  • the remote control module 112 can be operated to control the pulses provided by the pulse generator 1 10 and/or to change the programming of the pulse generator 1 10. Once programmed, the communications link between the control module 1 12 and the pulse generator 1 10 is terminated, and the pulse generator will provide pulsed stimulation at a preset intensity, for a preset duration and/or at preset intervals.
  • the implanted leads 102, 104 can also be used to record electrophysiological signals. Different signals can in principle be used, originating from different areas of the brain and from varying distances from the implantation site. Conveniently, the electrodes 106, 108 can detect/record local field potentials (LFPs). Alternatively, additional specialised non-circumferential detectors can be provided on the DBS lead e.g. at the tip of the DBS lead 102, 104.
  • LFPs local field potentials
  • additional specialised non-circumferential detectors can be provided on the DBS lead e.g. at the tip of the DBS lead 102, 104.
  • LFP is an electrophysiological signal generated by the summed electric current from neuronal assemblies in the brain.
  • Voltage is produced across the local extracellular space by action potentials and graded potentials in neurons in the area, and varies as a result of synaptic activity.
  • “Potential” refers to electrical potential, or voltage, and this can be recorded with the electrodes 106, 108 of the DBS leads 102, 104 when implanted into a patient. LFPs are therefore closely related to the activity of individual neurons. As such, LFPs are useful parameters to record and analyse. Other useful neurophysiological signals, for example seizure activity, can also be detected through DBS leads. When DBS is applied to a patient's brain, it modulates pathological oscillations in the
  • the DBS leads 102, 104 are segmented electrodes 106, 108 arranged in a band b around the circumference of the lead 102, 104.
  • This lead 102, 104 has two bands of electrodes and two circumferential or ring electrodes, but it will be appreciated that aspects and embodiments of the invention can utilise a variety of different leads with electrodes varying in number and arrangement.
  • the plurality of electrodes 106, 108 may be located in the same band b i.e. in the same transverse plane t relative to the longitudinal direction I of the electrode 102, 104.
  • the plurality of electrodes 106, 108 may be located in different bands b i.e. in different transverse planes t relative to the longitudinal direction I of the electrode 102, 104.
  • a plurality (e.g. 3, 4 or more) ring electrodes may be used.
  • An LFP in the beta oscillation range can therefore be detected at the electrodes 106 or 108 on a DBS lead 102 or 104, respectively.
  • a DBS lead 102, 104 is implanted into a patient's brain.
  • the target co-ordinates "X" for insertion are selected using imaging guidance as discussed above.
  • the coordinates of where the lead 102, 104 is inserted is calculated.
  • the distance "D" of electrodes 106, 108, or an electrode montage (midpoint co-ordinates between a pair of electrodes), from an intended stereotactic target "X" is calculated. If the characteristic physiological signal of the target structure (the target nucleus in Figure 4), e.g. Beta oscillations of Parkinson's Disease, is strongest at the stereotactic target, the electrodes 106, 108 that are closest to the desired target (X) should show the strongest LFP signal (with the highest value or amplitude). This is illustrated in Figures 5a and 5b. In Figure 5a, the stereotactic target coincides with or is very close to the actual physiological target. As such, the middle two electrodes are the closest and register a high or higher signal than the outer two electrodes, which are further away, and register a low or lower signal.
  • the characteristic physiological signal of the target structure the target nucleus in Figure 4
  • the electrodes 106, 108 that are closest to the desired target (X) should show the strongest LFP signal (with the highest value
  • the distance (D) (or optionally of a mathematical transform thereof) between (i) electrode positions or electrode montage positions on a DBS lead 102, 104 and (ii) an intended (image-based) target, against the strength of beta oscillatory signal (or optionally of a mathematical transform thereof), from each respective electrode/electrode montage can be plotted.
  • an electrode 106, 108 was not implanted well (i.e. the true physiological target X(T) was too far away from the stereotactic target selected on imaging X(F)) and needed to be replaced, the slope of the graph was positive. That is, the signal strength appeared to increase with increasing distance from the source of the LFP signals, which cannot be the case as signal strength attenuates with distance.
  • these calculations/determinations, and optionally plotting the data enables a determination of whether there is a significant discrepancy between the selected target (based on imaging) and the optimal physiological target.
  • the result can be calculated mathematically and/or illustrated graphically as discussed above to warn the physician when a target selected based on imaging may not be the optimum target.
  • the signal from an electrode is plotted against the distance of that electrode to the intended target (or a mathematical transform of the same), and while ignoring the order of the electrodes.
  • Figure 6 is a graph showing signal power strength measured at several DBS leads (in different patients, each line representing one implant in one person) intraoperatively (anonymised actual data) against distance of the electrodes from a stereotactic target.
  • Figure 7 illustrates this for one individual, where one lead (that with the negative slope) is well placed.
  • the visually chosen stereotactic target is the true physiological target.
  • Two attempts at implanting the target in the other hemisphere for the same patient is shown in grey and orange. On both attempts, the target selected using visual targeting was not the true physiological target, and this resulted in side effects despite the lead being placed close to the intended target. These show with positive slopes.
  • Figure 8(a) shows a plot of signal power (x axis) against implantation distance (y axis). The trend shown suggests a negative slope, which represents the standard or expected behaviour.
  • Figure 8(c) shows the same data, but where the logarithm of the signal power is instead plotted on the y-axis, again against distance on the x-axis. The trend is more clearly a negative slope. I.e. taking the logarithm of the data has improved the fit to the data.
  • Figure 8(b) shows a different fit - signal power on the y- axis against 1 /(distance D) 2 on the x-axis. Here a positive slope is seen - it is flipped compared with that of figure 8(a) or 8(c).
  • performing a mathematical transformation on the data may help provide a clearer indication of the quality of the location of an implant.
  • a more linear relationship between distance to target and signal could imply that that the lead is passing close to but not through the target. It could also imply (in a larger target) that most electrodes 106, 108 are within the intended target.
  • FIG. 8 is a plot showing a reconstruction of DBS leads in 3D stereotactic space, relative to an intended target X.
  • the power of the LFP signal at each bipolar electrode montage (the signal between a pair of electrodes) on the lead is indicated by a colour code, with that labelled "HIGH" representing the highest signal recorded.
  • the other two points are weaker signals.
  • the Figure on the left shows that the highest LFP is recorded at an electrode closest to the intended target X, and therefore the intended target is the true physiological target.
  • the Figure on the right is actual data illustrating the depictions in schematic Figure 5b and the real data ("REAL") in Figure 7.
  • the highest LFP signal is recorded in an electrode further away from the intended target X. Therefore, the true physiological target lies above the intended stereotactic target in this example with real data.
  • the "spot" closest to the physiological target represents the best position for DBS lead insertion.
  • aspects and embodiments of the invention thus enable a physician to assess whether a DBS target location, as calculated from CT/MRI imaging and possible reference to a stereotactic atlas, is actually suitable for DBS, or whether another position would be better.
  • the approximate position of the true target can be estimated from figures 6, 7 and 9 if the geometry and spacing of the electrodes 106, 108 on a specific DBS lead 102, 104 is known.
  • Aspects and embodiments of the present invention further allow for an easy assessment to be made as to whether or not a better physiological target is available - without the need for blind revision surgery or invasive electrophysiology at the time of surgery
  • tracking the calculated results can also help monitor errors in stereotactic targeting systems (e.g. a stereotactic frame error or a systematic CT-MRI image fusion error). Tracking over time may also provide an indication that an electrode is moving over time ("electrode migration"). Furthermore, the intercept of the line of best fit on the axis representing signal strength provides an estimate for the power of the signal at the target X. This can be utilized to judge the adequacy of an implant and also to model the signal field.

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Abstract

L'invention porte sur un procédé de vérification de l'emplacement d'implantation d'un fil de stimulation cérébrale profonde (SCP) comportant une pluralité d'électrodes. Le procédé consiste à dériver une valeur représentative d'un signal électrophysiologique obtenu à partir de deux des électrodes ou plus. Le procédé consiste également à comparer les valeurs dérivées à la distance de l'électrode par rapport à l'emplacement d'une cible stéréotaxique visée. Le procédé consiste en outre à calculer une fonction mathématique représentative de la manière dont le signal varie avec la distance. Sur la base de la fonction mathématique calculée, la proximité d'un fil de SCP implanté vis-à-vis d'une position d'implantation cible est ensuite déterminée. L'invention concerne également un système de vérification de l'emplacement d'implantation d'un fil de stimulation cérébrale profonde (SCP) comprenant une pluralité d'électrodes. L'invention concerne en outre un procédé de réalisation d'une stimulation cérébrale profonde (SCP).
PCT/GB2017/052418 2016-08-16 2017-08-16 Vérification de l'emplacement d'implantation d'un fil de stimulation cérébrale profonde (scp) WO2018033732A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB1613982.6 2016-08-16
GBGB1613982.6A GB201613982D0 (en) 2016-08-16 2016-08-16 Assessing suitability of implanted target in deep brain stimulation (DBS)

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WO2018033732A1 true WO2018033732A1 (fr) 2018-02-22

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113797440A (zh) * 2021-09-27 2021-12-17 首都医科大学附属北京天坛医院 基于影像和电生理实时定位的脑深部电极自动植入系统
WO2022018530A1 (fr) * 2020-07-24 2022-01-27 Cochlear Limited Réseau d'électrodes vestibulaires
CN114222604A (zh) * 2019-06-26 2022-03-22 阿尔法欧米伽医疗科技公司 大脑导航引线定位及其方法
WO2023230237A1 (fr) * 2022-05-25 2023-11-30 University Of Florida Research Foundation, Incorporated Appareil et procédé pour déterminer des paramètres de stimulation pour une stimulation cérébrale profonde (dbs)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008072125A1 (fr) * 2006-12-13 2008-06-19 Koninklijke Philips Electronics, N.V. Premier placement correct d'une dérivation de la stimulation cérébrale profonde
WO2012145244A1 (fr) * 2011-04-20 2012-10-26 Medtronic, Inc. Méthode et appareil pour évaluer l'activation neurale
US20150258339A1 (en) * 2014-03-11 2015-09-17 Oregon Health & Science University Deep brain electrode placement and stimulation based on brown adipose tissue temperature
US20160051812A1 (en) * 2014-08-20 2016-02-25 Greenville Neuromodulation Center Method and System For Physiological Target Localization From Macroelectrode Recordings and Monitoring Spinal Cord Function

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008072125A1 (fr) * 2006-12-13 2008-06-19 Koninklijke Philips Electronics, N.V. Premier placement correct d'une dérivation de la stimulation cérébrale profonde
WO2012145244A1 (fr) * 2011-04-20 2012-10-26 Medtronic, Inc. Méthode et appareil pour évaluer l'activation neurale
US20150258339A1 (en) * 2014-03-11 2015-09-17 Oregon Health & Science University Deep brain electrode placement and stimulation based on brown adipose tissue temperature
US20160051812A1 (en) * 2014-08-20 2016-02-25 Greenville Neuromodulation Center Method and System For Physiological Target Localization From Macroelectrode Recordings and Monitoring Spinal Cord Function

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114222604A (zh) * 2019-06-26 2022-03-22 阿尔法欧米伽医疗科技公司 大脑导航引线定位及其方法
WO2022018530A1 (fr) * 2020-07-24 2022-01-27 Cochlear Limited Réseau d'électrodes vestibulaires
CN113797440A (zh) * 2021-09-27 2021-12-17 首都医科大学附属北京天坛医院 基于影像和电生理实时定位的脑深部电极自动植入系统
WO2023230237A1 (fr) * 2022-05-25 2023-11-30 University Of Florida Research Foundation, Incorporated Appareil et procédé pour déterminer des paramètres de stimulation pour une stimulation cérébrale profonde (dbs)

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