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Abstract BACKGROUND The ventralis intermedius (VIM) nucleus of the thalamus is the primary surgical target for treatment of tremor. Most centers rely on indirect targeting based on atlas-defined coordinates rather than patient-specific anatomy, making intraoperative physiological mapping critical. Detailed identification of this target based on patient-specific anatomic features can help optimize the surgical treatment of tremor. OBJECTIVE To study colored fractional anisotropic images and diffusion tensor imaging (DTI) tractography to identify characteristic magnetic resonance appearances of the VIM nucleus. METHODS Four patients undergoing stereotactic surgery for essential tremor (ET) were retrospectively studied with analysis of magnetic resonance imaging-based colored fractional anisotropy (FA) images and fiber tractography. All were scanned with a 1.5-T magnetic resonance imaging unit, and all sequences were obtained before frame placement. Because the goal of this study was to identify the DTI characteristics of physiologically defined VIM nucleus, we selected and studied patients who had undergone DTI and had efficacious tremor control with intraoperative microlesioning effect and tremor reduction with less than 2.0-V stimulation. RESULTS Analysis of color FA maps, which graphically illustrate fiber directionality, revealed consistent anatomic patterns. The region of the VIM nucleus can be seen as an intermediate region where there is a characteristic transition of color. Presumptive VIM nucleus interconnectivity with sensorimotor cortex and cerebellum was identified via the internal capsule and the superior cerebellar peduncle, respectively. FA maps could also be used to distinguish segments of gray matter, white matter, and gray-white matter boundaries. CONCLUSION Analysis of DTI and FA maps on widely available 1.5-T magnetic resonance imaging yields clear identification of various structures key to neurosurgical targeting. Prospective evaluation of integrating DTI into neurosurgical planning may be warranted.

Abstract BACKGROUND Efficacy in deep brain stimulation (DBS) is dependent on precise positioning of electrodes within the brain. Intraoperative fluoroscopy, computed tomography (CT), or magnetic resonance imaging are used for stereotactic intraoperative localization (StIL), but the utility of biplanar X-ray has not been evaluated in detail. OBJECTIVE To determine if analysis of orthogonal biplanar X-rays using graphical analysis (GA), ray tracing (RT), and/or perspective projection (PP) can be utilized for StIL. METHODS A review of electrode tip positions comparing postoperative CT to X-ray methods was performed for DBS operations containing orthogonal biplanar X-ray with referential spheres and pins. RESULTS Euclidean (Re) errors for final DBS electrode position on intraoperative X-rays vs postoperative CT using GA, RT, and PP methods averaged 1.58 mm (±0.75), 0.74 mm (±0.45), and 1.07 mm (±0.64), respectively (n = 56). GA was more accurate with a ventriculogram. RT and PP predicted positions that correlated with third ventricular structures on ventriculogram cases. RT was the most stable but required knowledge of the geometric setup. PP was more flexible than RT but required well-distributed reference points. A single case using the O-arm demonstrated Re errors of 0.43 mm and 0.28 mm for RT and PP, respectively. In addition, these techniques could also be used to calculate directional electrode rotation. CONCLUSION GA, RT, and PP can be employed for precise StIL during DBS using orthogonal biplanar X-ray. These methods may be generalized to other stereotactic procedures or instances of biplanar imaging such as angiograms, radiosurgery, or injection therapeutics.

Deep brain stimulation (DBS) of the subthalamic nucleus is an established therapeutic option for managing motor symptoms of Parkinson's disease. We conducted a double-blind, sham-controlled, randomised controlled trial to assess subthalamic nucleus DBS, with a novel multiple independent contact current-controlled (MICC) device, in patients with Parkinson's disease. This trial took place at 23 implanting centres in the USA. Key inclusion criteria were age between 22 and 75 years, a diagnosis of idiopathic Parkinson's disease with over 5 years of motor symptoms, and stable use of anti-parkinsonian medications for 28 days before consent. Patients who passed screening criteria were implanted with the DBS device bilaterally in the subthalamic nucleus. Patients were randomly assigned in a 3:1 ratio to receive either active therapeutic stimulation settings (active group) or subtherapeutic stimulation settings (control group) for the 3-month blinded period. Randomisation took place with a computer-generated data capture system using a pre-generated randomisation table, stratified by site with random permuted blocks. During the 3-month blinded period, both patients and the assessors were masked to the treatment group while the unmasked programmer was responsible for programming and optimisation of device settings. The primary outcome was the difference in mean change from baseline visit to 3 months post-randomisation between the active and control groups in the mean number of waking hours per day with good symptom control and no troublesome dyskinesias, with no increase in anti-parkinsonian medications. Upon completion of the blinded phase, all patients received active treatment in the open-label period for up to 5 years. Primary and secondary outcomes were analysed by intention to treat. All patients who provided informed consent were included in the safety analysis. The open-label phase is ongoing with no new enrolment, and current findings are based on the prespecified interim analysis of the first 160 randomly assigned patients. The study is registered with ClinicalTrials.gov, NCT01839396. Between May 17, 2013, and Nov 30, 2017, 313 patients were enrolled across 23 sites. Of these 313 patients, 196 (63%) received the DBS implant and 191 (61%) were randomly assigned. Of the 160 patients included in the interim analysis, 121 (76%) were randomly assigned to the active group and 39 (24%) to the control group. The difference in mean change from the baseline visit (post-implant) to 3 months post-randomisation in increased ON time without troublesome dyskinesias between the active and control groups was 3·03 h (SD 4·52, 95% CI 1·3–4·7; p<0·0001). 26 serious adverse events in 20 (13%) patients occurred during the 3-month blinded period. Of these, 18 events were reported in the active group and 8 in the control group. One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation. This double-blind, sham-controlled, randomised controlled trial provides class I evidence of the safety and clinical efficacy of subthalamic nucleus DBS with a novel MICC device for the treatment of motor symptoms of Parkinson's disease. Future trials are needed to investigate potential benefits of producing a more defined current field using MICC technology, and its effect on clinical outcomes. Boston Scientific.

Deep brain stimulation (DBS) is a neurosurgical procedure that depends on high-accuracy targeting of structures to implant electrodes within the brain. The positioning of these electrodes in the brain determines the long-term efficacy of treating diseases such as Parkinson's disease, essential tremor, or dystonia. Misplaced electrodes in DBS can lead to poor efficacy and stimulation-induced side effects. Widespread targeting errors and variability have been published throughout the literature. As such, improvement in targeting accuracy is needed to enhance the quality of the procedures. A stereotactic phantom was utilized to test and adjust targeting before the surgical placement in the brain for 91 sequential electrodes. The tip of the microelectrode, the first rigid point in time, was measured and compared to the planned target. The technique utilized a to-target cannula with an XY stage that allowed x-axis and y-axis adjustments and correction for inaccuracies relative to the phantom. A calculation was developed to convert anatomical angles (sagittal and coronal) provided by commercial planning stations to spherical angles to calculate points along a trajectory. Error calculations included each dimensional axis, Euclidean error, and radial error. Bends in the cannula and microelectrode were observed and corrected by referencing the phantom. All 91 first-pass tracks traversed the intended target, and three electrodes required a second mapping track beyond the first penetration due to neurophysiological and intraoperative testing. The results showed overall ultra-high (0-0.5 mm) to high (>0.5-1 mm) accuracy, an average Euclidean error of 0.66±0.30 mm, and a radial error of 0.45±0.28 mm with dimensional errors of less than 0.5 mm per axis. The utilization of a stereotactic phantom is an important tool to enhance the stereotactic targeting before insertion into the brain. This phantom technique yielded ultra-high to high accuracy in error calculations. Future methods and studies should focus on error minimization to enhance these DBS mechanical accuracy and correlations with clinical outcomes.

Frame-based stereotactic localization generally assumes that all required fiducials are present in a single-slice image which can then be used to form targeting coordinates. Previously, we have published the use of novel localizers and mathematics that can improve stereotactic localization. As stereotactic procedures include numerous imaging slices, we sought to investigate, develop, and test techniques that utilize multiple slices for stereotactic localization and provide a solution for a parallel bipanel N-localizer.  Several multi-slice equations were tested. Specifically, multi-slice stereotactic matrices (ms-SM) and multi-slice normal to parallel planes (ms-nPP) were of particular interest. Bipanel (2N) and tripanel (3N) localizer images were explored to test approaches for stereotactic localization. In addition, combination approaches using single-slice stereotactic matrices (ss-SM) and multi-slice methods were tested. Modification of ss-SM to form ms-SM was feasible. Likewise, a method to determine ms-nPP was developed. For the special case of the parallel bipanel N-localizer, single-slice and multi-slice methods fail, but a novel non-linear solution is a robust solution for ms-nPP. Several methods for single-slice and multi-slice stereotactic localization are described and can be adapted for nearly any stereotactic system. It is feasible to determine ms-SM and ms-nPP. In particular, these methods provide an overdetermined means to calculate the vertical z, which is determined for a tripanel system using single-slice methods. In addition, the multi-slice methods can be used for extrapolation outside of the localizer space. Importantly, a novel non-linear solution can be used for parallel bipanel N-localizer systems, where other methods fail. Finally, multi-slice stereotactic localization assumes strict patient and imaging system stability, which should be carefully assessed for each case.

 Frame-based stereotaxis has been widely utilized for precise neurosurgical procedures throughout the world for nearly 40 years. The N-localizer is an integral component of most of the extant systems. Analysis of targeting errors related to the N-localizer has not been carried out in sufficient detail. We highlight these potential errors and develop methods to reduce them.  Methods: N-localizer systems comprising three and four N-localizers of various geometries were analyzed using Monte Carlo (MC) simulations. The simulations included native and altered geometric dimensions (Width [W] x Height [H]). Errors were computed using the MC simulations that included the x- and y-axes of vertically oriented rods, that altered the W/H ratio, and that added a fourth N-localizer to a three N-localizer system.  Results: The inclusion of an overdetermined system of equations and the geometries of the N-localizer systems had significant effects on target errors. Root Mean Square Errors (RMS-e) computed via millions of MC iterations for each study demonstrated that errors were reduced by (1) inclusion of the x- and y-coordinates of the vertically oriented rods, (2) a greater triangular area enclosed by the diagonal fiducials of the N-localizer system (stereotactic triangle), (3) a larger W/H ratio, and (4) an N-localizer system that comprised four N-localizers. Monte Carlo simulations of Root Mean Square error (RMS-e) is a useful technique to understand targeting while using N-localizer systems in stereotactic neurosurgery. The application of vertical rod positions enhances computational accuracy and can be performed on any N-localizer system. Keeping the target point within the stereotactic triangle enclosed by the diagonal rods can also reduce errors. Additional optimizations of N-localizer geometry may also reduce potential targeting errors. Further analysis is needed to confirm these findings which may have clinical importance.

Introduction Facial pain is often debilitating and can be characterized by a sharp, stabbing, burning, aching, and dysesthetic sensation. Specifically, trigeminal neuropathic pain (TNP), anesthesia dolorosa, and persistent idiopathic facial pain (PIFP) are difficult diseases to treat, can be quite debilitating and an effective, enduring treatment remains elusive. Methods We retrospectively reviewed our early experience with stimulation involving the trigeminal and sphenopalatine ganglion stimulation for TNP, anesthesia dolorosa, and PIFP between 2010–2014 to assess the feasibility of implanting at these ganglionic sites. Seven patients received either trigeminal and/or sphenopalatine ganglion stimulation with or without peripheral nerve stimulation, having failed multiple alternative modalities of treatment. The treatments were tailored on the physical location of pain to ensure regional coverage with the stimulation. Results Fluoroscopy or frameless stereotaxy was utilized to place the sphenopalatine and/or trigeminal ganglion stimulator. All patients were initially trialed before implantation. Trial leads implanted in the pterygopalatine fossa near the sphenopalatine ganglion were implanted via transpterygoid (lateral-medial, infrazygomatic) approach. Trial leads were implanted in the trigeminal ganglion via percutaneous Hartel approach, all of which resulted in masseter contraction. Patients who developed clinically significant pain improvement underwent implantation. The trigeminal ganglion stimulation permanent implants involved placing a grid electrode over Meckel’s cave via subtemporal craniotomy, which offered a greater ability to stimulate subdivisions of the trigeminal nerve, without muscular (V3) side effects. Two of the seven overall patients did not respond well to the trial and were not implanted. Five patients reported pain relief with up to 24-month follow-up. Several of the sphenopalatine ganglion stimulation patients had pain relief without any paresthesias. There were no electrode migrations or post-surgical complications. Conclusions Refractory facial pain may respond positively to ganglionic forms of stimulation. It appears safe and durable to implant electrodes in the pterygopalatine fossa via a lateral transpterygoid approach. Also, implantation of an electrode grid overlying Meckel’s cave appears to be a feasible alternative to the Hartel approach. Further investigation is needed to evaluate the usefulness of these approaches for various facial pain conditions.

The N-localizer is generally utilized in a 3-panel or, more rarely, a 4-panel system for computing stereotactic positions. However, a stereotactic frame that incorporates a 2-panel (bipanel) N-localizer system with panels affixed to only the left and right sides of the frame offers several advantages: improved ergonomics to attach the panels, reduced claustrophobia for the patient, mitigation of posterior panel contact with imaging systems, and reduced complexity. A bipanel system that comprises two standard N-localizer panels yields only two three-dimensional (3D) coordinates, which are insufficient to solve for the stereotactic matrix without further information. While additional information to determine the stereotactic positions could include scalar distances from Digital Imaging and Communications in Medicine (DICOM) metadata or 3D regression across the imaging volume, both have risks related to noise and error propagation. Therefore, we sought to develop new stereotactic localizers that comprise only lateral fiducials (bipanel) that leave the front and back regions of the patient accessible but that contain enough information to solve for the stereotactic matrix using each image independently. Methods: To solve the stereotactic matrix, we assumed the need to compute three or more 3D points from a single image. Several localizer options were studied using Monte Carlo simulations to understand the effect of errors on the computed target location. The simulations included millions of possible combinations for computing the stereotactic matrix in the presence of random errors of 1mm magnitude. The matrix then transformed coordinates for a target that was placed 50mm anterior, 50mm posterior, 50mm lateral, or 50mm anterior and 50mm lateral to the centre of the image. Simulated cross-sectional axial images of the novel localizer systems were created and converted into DICOM images representing computed tomography (CT) images. Results: Three novel models include the M-localizer, F-localizer, and Z-localizer. For each of these localizer systems, optimized results were obtained using an overdetermined system of equations made possible by more than three diagonal bars. In each case, the diagonal bar position was computed using standard N-localizer mathematics. Additionally, the M-localizer allowed adding a computation using the Sturm-Pastyr method. Monte Carlo simulation demonstrated that the Z-localizer provided optimal results.INTRODUCTIONThe N-localizer is generally utilized in a 3-panel or, more rarely, a 4-panel system for computing stereotactic positions. However, a stereotactic frame that incorporates a 2-panel (bipanel) N-localizer system with panels affixed to only the left and right sides of the frame offers several advantages: improved ergonomics to attach the panels, reduced claustrophobia for the patient, mitigation of posterior panel contact with imaging systems, and reduced complexity. A bipanel system that comprises two standard N-localizer panels yields only two three-dimensional (3D) coordinates, which are insufficient to solve for the stereotactic matrix without further information. While additional information to determine the stereotactic positions could include scalar distances from Digital Imaging and Communications in Medicine (DICOM) metadata or 3D regression across the imaging volume, both have risks related to noise and error propagation. Therefore, we sought to develop new stereotactic localizers that comprise only lateral fiducials (bipanel) that leave the front and back regions of the patient accessible but that contain enough information to solve for the stereotactic matrix using each image independently. Methods: To solve the stereotactic matrix, we assumed the need to compute three or more 3D points from a single image. Several localizer options were studied using Monte Carlo simulations to understand the effect of errors on the computed target location. The simulations included millions of possible combinations for computing the stereotactic matrix in the presence of random errors of 1mm magnitude. The matrix then transformed coordinates for a target that was placed 50mm anterior, 50mm posterior, 50mm lateral, or 50mm anterior and 50mm lateral to the centre of the image. Simulated cross-sectional axial images of the novel localizer systems were created and converted into DICOM images representing computed tomography (CT) images. Results: Three novel models include the M-localizer, F-localizer, and Z-localizer. For each of these localizer systems, optimized results were obtained using an overdetermined system of equations made possible by more than three diagonal bars. In each case, the diagonal bar position was computed using standard N-localizer mathematics. Additionally, the M-localizer allowed adding a computation using the Sturm-Pastyr method. Monte Carlo simulation demonstrated that the Z-localizer provided optimal results.The three proposed novel models meet our design objectives. Of the three, the Z-localizer produced the least propagation of error. The M-localizer was simpler and had slightly more error than the Z-localizer. The F-localizer produced more error than either the Z-localizer or M-localizer. Further study is needed to determine optimizations using these novel models.CONCLUSIONThe three proposed novel models meet our design objectives. Of the three, the Z-localizer produced the least propagation of error. The M-localizer was simpler and had slightly more error than the Z-localizer. The F-localizer produced more error than either the Z-localizer or M-localizer. Further study is needed to determine optimizations using these novel models.

Ray tracing (RT) and perspective projection (PP) using fiducial-based registration can be used to determine points of interest in biplanar X-ray imaging. We sought to investigate the implementation of these techniques as they pertain to X-ray imaging geometry. The mathematical solutions are presented and then implemented in a phantom and actual case with numerical tables and imaging. The X-ray imaging is treated like a Cartesian system in millimeters (mm) with a standard frame-based stereotactic system. In this space, the point source is the X-ray emitter (focal spot), the plane is the X-ray detector, and fiducials are in between the source and plane. In a phantom case, RT was able to predict locations of fiducials after moving the point source. Also, a scaled PP matrix could be used to determine imaging geometry, which could then be used in RT. Automated identification of spherical fiducials in 3D was possible using a center of mass computation with average Euclidean error relative to manual measurement of 0.23 mm. For PP, RT projection or a combinatorial approach could be used to facilitate matching 3D to 2D points. Despite being used herein for deep brain stimulation (DBS), utilization of this kind of imaging analysis has wide medical and non-medical applications.

All stereotactic neurosurgical procedures utilize coordinate systems to allow navigation through the brain to a target. During the surgical planning, indirect and direct targeting determines the planned target point and trajectory. This targeting allows a surgeon to precisely reach points along the trajectory while minimizing risks to critical structures. Oftentimes, once a target point and a trajectory are determined, a frame-based coordinate system is used for the actual procedure. Considerations include the use of various coordinate spaces such as the anatomical (\\begin{document}{X}\\end{document}), the frame (\\begin{document}{X'}\\end{document}), the head-stage (\\begin{document}{X''}\\end{document}), and an atlas. Therefore, the relationships between these coordinate systems are integral to the planning and implementation of the neurosurgical procedure. Although coordinate transformations are handled in planning via stereotactic software, critical understanding of the mathematics is required as it has implications during surgery. Further, intraoperative applications of these coordinate conversions, such as for surgical navigation from the head-stage, are not readily available in real-time. Herein, we discuss how to navigate these coordinate systems and provide implementations of the techniques with samples.