Spontaneous Intracranial Hypotension in the Critical Patient.

Spontaneous intracranial hypotension typically manifests with orthostatic headaches and is caused by spinal dural tears, ruptured meningeal diverticula, or CSF-venous fistulas. While most patients are diagnosed and treated in the outpatient setting, some patients will occasionally present in the emergent ICU setting due to subdural hematomas, coma, or downward brain herniation. In this review paper, we will discuss the diagnostic and treatment steps that intensivists can undertake to coordinate a team approach to successfully manage these patients. A brief general overview of spontaneous intracranial hypotension will also be discussed.

CT-guided Fibrin Glue Occlusion of Cerebrospinal Fluid-Venous Fistulas.

Background Cerebrospinal fluid-venous fistulas (CVFs) are one of the less common etiologic causes of spontaneous intracranial hypotension. CVFs are most commonly treated with open surgical ligation and have reportedly not responded well to percutaneous treatments. Purpose To study treatment outcomes of CT-guided fibrin glue occlusion for CVFs. Materials and Methods Retrospective review of medical records from two institutions was performed for all patients with CVFs who underwent CT-guided percutaneous fibrin glue occlusion from March to October 2020. CVFs were assessed for resolution or persistence at posttreatment decubitus CT myelography (CTM). Pre- and posttreatment brain MRI scans were reviewed for principal signs of spontaneous intracranial hypotension. Clinical symptoms were documented before and immediately after therapy, and the current symptoms to date after fibrin glue occlusion were documented. Results CT-guided fibrin glue occlusion was performed in 13 patients (mean age, 62 years ± 14 [standard deviation]; eight women) with CVFs. Ten of 10 patients who underwent final posttreatment decubitus CTM examinations showed CVF resolution. All 13 patients showed improvement on posttreatment brain MRI scans. All 13 patients are currently asymptomatic, although three patients were asymptomatic before fibrin glue occlusion. Conclusion CT-guided fibrin glue occlusion is an effective treatment for patients with cerebrospinal fluid-venous fistulas (CVFs). Direct fibrin glue administration within the CVF may be one of the key factors for success. Further studies are needed to determine the long-term efficacy of this treatment. © RSNA, 2021.

Outcomes of a Multicenter, Prospective, Crossover, Randomized Controlled Trial Evaluating Subperception Spinal Cord Stimulation at ≤1.2 kHz in Previously Implanted Subjects.

OBJECTIVE: The WHISPER randomized controlled trial (RCT) evaluates safety and clinical effectiveness of subperception spinal cord stimulation (SCS) at ≤1.2 kHz in subjects previously implanted with an SCS system for treatment of chronic, neuropathic pain. METHODS: WHISPER is a prospective, multicenter RCT with a crossover design sponsored by Boston Scientific, Marlborough, MA (ClinicalTrials.gov: NCT02314000). Eligible subjects were randomized (N = 140) to receive subperception or supraperception for three months and then crossed over to receive the alternative. Upon completion of crossover period, subjects who preferred subperception were followed up to one year. Overall pain, quality-of-life, and other outcomes were collected in the study. The primary endpoint was the overall pain responder rate (≥50% improvement from baseline) with no increase in medications. Secondary endpoints consisted of pain scores, physical disability, quality of life, and treatment preference. RESULTS: The study met its primary endpoint and demonstrated noninferiority between supraperception and subperception in a prespecified cohort of 70 randomized subjects (Interim Analysis). Thirty-nine percent of subjects with subperception settings and 29% with supraperception settings had a greater than or equal to 50% reduction in their overall pain scores with no increase in average daily medication at three-months post-activation as compared with baseline. Further assessment of all participating study subjects (N = 140) revealed similar results. Subjects were previously implanted 3.8 ± 2 years and had a disability score (Oswestry Disability Index) of 70.2 ± 11.4 at study start. Of the randomized subjects that completed the End of Period 2 Visit, 93 (66%) preferred subperception SCS and their mean overall pain reduced from 7.3 ± 1.1 (N = 89) at baseline to 4.0 ± 2.1 (N = 80) at 12-months post-activation. Post hoc analysis also demonstrated that multiple options provide superior outcomes, as supported by a 74% increase in the responder rate when subjects could choose their most effective option (47%) compared with supraperception alone (27%). DISCUSSION: Subperception SCS at ≤1.2 kHz is safe and effective in subjects with extreme physical disability and previously implanted for chronic pain. Further, by providing study participants with different waveform options, increased pain relief was achieved.

Trigeminal and sphenopalatine ganglion stimulation for intractable craniofacial pain--case series and literature review.

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.

A paradigm for awake intraoperative memory mapping during forniceal stimulation.

A case report is presented detailing the successful use of awake intraoperative memory testing while using white matter stimulation in order to isolate the fornix tracks involved in memory function. The identification of the white matter tracks of the fornix that were involved in memory function was used to tailor the neurosurgical resection of a third ventricle tumor that was impinging on the fornix in order to successfully preserve memory functioning in the patient.

Stereotactic Localization: From Single-Slice to Multi-Slice Registration Including a Novel Solution for Parallel Bipanels.

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.

Motion Detection and Correction for Frame-Based Stereotactic Localization.

Frame-based stereotactic localization is an important step for targeting during a surgical procedure. The motion may cause artifacts in this step reducing the accuracy of surgical targeting. While modeling of motion in real-life scenarios may be difficult, herein we analyzed the case where motion was suspected to impact the localization step. In this case, a scan with and without motion was performed with a 3N localizer, allowing for a thorough analysis. Pseudo-bending of straight rods was seen when analyzing the data. This pseudo-bending appears to occur because head-frame motion during imaging acquisition decreases the accuracy of the subsequent reconstruction, which depends on Digital Imaging and Communications in Medicine (DICOM) metadata to specify the slice-to-slice location that assumes embedded object stability. Comparison of single-slice and multi-slice stereotactic localization allowed for comparative errors for each slice in a volume. This comparative error demonstrated low error when the patient was under general anesthesia and presumed not to have moved, whereas a higher error was present during the scan with motion. Pseudo-bending can be corrected by using only localizer fiducial-based information to reorient the pixels in the volume, thus creating a reoriented localizer scan. Finally, targeting demonstrated a low error of 0.1 mm (+/- 0.1 mm) using this reoriented localizer scan, signifying that this method could be used to improve or recover from motion problems. Finally, it is concluded that stability and elimination of motion for all images utilized for stereotactic surgery are critical to ensure the best possible accuracy for the procedure.

Monte Carlo Simulation of Errors for N-localizer Systems in Stereotactic Neurosurgery: Novel Proposals for Improvements.

INTRODUCTION:  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. CONCLUSION: 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.

Novel Geometries for Stereotactic Localizers.

INTRODUCTION: 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. CONCLUSION: 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.

The V-Localizer for Stereotactic Guidance.

Image-guidance for frame-based stereotaxis is facilitated by incorporating three to four N-localizers or Sturm-Pastyr localizers into a stereotactic frame. An extant frame that incorporates only two N-localizers violates the fundamental principle of the N-localizer, which requires three non-colinear points to define a plane in three-dimensional space. Hence, this two N-localizer configuration is susceptible to error. The present article proposes the V-localizer that comprises multiple diagonal bars to provide four or more non-colinear points to minimize error.

Double blind randomized controlled trial of deep brain stimulation for obsessive-compulsive disorder: Clinical trial design.

Obsessive-compulsive disorder (OCD), a leading cause of disability, affects ~1-2% of the population, and can be distressing and disabling. About 1/3 of individuals demonstrate poor responsiveness to conventional treatments. A small proportion of these individuals may be deep brain stimulation (DBS) candidates. Candidacy is assessed through a multidisciplinary process including assessment of illness severity, chronicity, and functional impact. Optimization failure, despite multiple treatments, is critical during screening. Few patients nationwide are eligible for OCD DBS and thus a multi-center approach was necessary to obtain adequate sample size. The study was conducted over a six-year period and was a NIH-funded, eight-center sham-controlled trial of DBS targeting the ventral capsule/ventral striatum (VC/VS) region. There were 269 individuals who initially contacted the sites, in order to achieve 27 participants enrolled. Study enrollment required extensive review for eligibility, which was overseen by an independent advisory board. Disabling OCD had to be persistent for ≥5 years despite exhaustive medication and behavioral treatment. The final cohort was derived from a detailed consent process that included consent monitoring. Mean illness duration was 27.2 years. OCD symptom subtypes and psychiatric comorbidities varied, but all had severe disability with impaired quality of life and functioning. Participants were randomized to receive sham or active DBS for three months. Following this period, all participants received active DBS. Treatment assignment was masked to participants and raters and assessments were blinded. The final sample was consistent in demographic characteristics and clinical features when compared to other contemporary published prospective studies of OCD DBS. We report the clinical trial design, methods, and general demographics of this OCD DBS sample.

A role of diffusion tensor imaging in movement disorder surgery.

The safe and reversible nature of deep brain stimulation (DBS) has allowed movement disorder neurosurgery to become commonplace throughout the world. Fundamental understanding of individual patient's anatomy is critical for optimizing the effects and side effects of DBS surgery. Three patients undergoing stereotactic surgery for movement disorders, at the institution's intraoperative magnetic resonance imaging operating suite, were studied with fiber tractography. Stereotactic targets and fiber tractography were determined on preoperative magnetic resonance imagings using the Schaltenbrand-Wahren atlas for definition in the BrainLab iPlan software (BrainLAB Inc., Feldkirchen, Germany). Subthalamic nucleus, globus pallidus interna, and ventral intermediate nucleus targets were studied. Diffusion tensor imaging parameters used ranged from 2 to 8 mm for volume of interest in the x/y/z planes, fiber length was kept constant at 30 mm, and fractional anisotropy threshold varied from 0.20 to 0.45. Diffusion tensor imaging tractography allowed reliable and reproducible visualization and correlation between frontal eye field, premotor, primary motor, and primary sensory cortices via corticospinal tracts and corticopontocerebellar tracts. There is an apparent increase in the number of cortical regions targeted by the fiber tracts as the region of interest is enlarged. This represents a possible mechanism of the increased effects and side effects observed with higher stimulation voltages. Currently available diffusion tensor imaging techniques allow potential methods to characterize the effects and side effects of DBS. This technology has the potential of being a powerful tool to optimize DBS neurosurgery.

Diffusion tensor imaging (DTI) and colored fractional anisotropy (FA) mapping of the subthalamic nucleus (STN) and the globus pallidus interna (GPi).

INTRODUCTION: The subthalamic nucleus (STN) and the globus pallidus internus (GPi) are the most common surgical targets for the treatment of Parkinson's disease. We studied directionally colored fractional anisotropy (FA) and diffusion tensor imaging (DTI) sequences to better target these anatomical regions. METHODS: Four patients undergoing stereotactic surgery for movement disorders were studied. Stereotactic targets and fiber tractography were determined on MRIs using the Schaltenbrand-Wahren atlas for definition in the iPlan software. In addition, post-operative imaging was fused to preoperative FA sequences for end-result identification. Axial, sagittal, and coronal images of the FA sequence were studied. DTI parameters used ranged from 2 to 4 mm for voxel size in the x/y/z planes, fiber length was kept constant at 15 mm and FA threshold of 0.25. RESULTS: Colored FA maps resulted in a key signature in and around the STN and GPi. Regions identified include, but were not limited to: the internal capsule, nigral projections, the thalamic fasciculus, Forel's fields H1 and H2, zona incerta, suthalamic fasciculus, tegmental tracts, and cerebello-rubro-thalamic tract. CONCLUSIONS: Colored FA maps allow a potential method to identify the STN and GPi accurately. DTI has proven to be a powerful tool that can be used to augment identification of the STN nucleus and GPi used for stereotactic surgery.

Coordinate Systems for Navigating Stereotactic Space: How Not to Get Lost.

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 ([Formula: see text]), the frame ([Formula: see text]), the head-stage ([Formula: see text]), 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.

Applied Mathematics of Ray Tracing and Perspective Projection in Fiducial-Based Registration of X-Ray Images.

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.

Developing a Spinal CSF Leak Program in a Multihospital Network.

OBJECTIVE: Spontaneous spinal cerebrospinal fluid (CSF) leaks are rare and challenging to diagnose and treat. Patients may present to a variety of physicians, and many patients are often referred to a specialized center with a dedicated spinal CSF leak program and expertise in this condition. To our knowledge, there are no reported publications on how to create such a program. CONCLUSION: In this article, we describe the specific steps we took to develop a spinal CSF leak program, which we have implemented over a multihospital network.

Biplanar X-Ray Methods for Stereotactic Intraoperative Localization in Deep Brain Stimulation Surgery.

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.

Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomised, sham-controlled study.

BACKGROUND: 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. METHODS: 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. FINDINGS: 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. INTERPRETATION: 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. FUNDING: Boston Scientific.

Impact of anatomic features in the endovascular embolization of 181 anterior communicating artery aneurysms.

BACKGROUND AND PURPOSE: We analyzed the impact of detailed anatomic characteristics on the results of endovascular coil embolization for anterior communicating artery (AcoA) aneurysms and developed a predictive model estimating the probability of successful endovascular treatment. METHODS: One hundred eighty-one AcoA aneurysms were treated with endovascular coil embolization between August 1991 and November 2005. Morphological characteristics that were analyzed included direction of the dome, location of the neck, association with hypoplasia or aplasia of AcoA complex vessels, sac, and neck size. Immediate clinical and anatomic results, long-term morbidity/mortality, recanalization rate, and delayed aneurysm thrombosis were analyzed. ORs were calculated for each anatomic and clinical result and logistic regression was used in formulating a predictive model. RESULTS: There were 115 females and 66 males. Age range was 9 to 86 years (mean 57). Factors significantly associated with complete embolization included small aneurysms (<10 mm), small neck (<4 mm), and anterior dome orientation. Factors significantly associated with aneurysm recanalization after long-term follow-up included aneurysm domes >10 mm, neck location on the AcoA, posterior dome orientation, and incomplete original embolization. Globally, the majority of patients remained neurologically intact or unchanged after the procedure (92.8%). Mortality was significantly influenced by the preoperative condition of the patient. The predictive model successfully represented the likely outcomes based on morphological features. CONCLUSIONS: AcoA aneurysm coil embolization can be safely performed with acceptable rates of morbidity. Dome and neck orientation, sack and neck size, sac-to-neck ratio, and associated anomalies should be considered to accurately assess the probability of successful treatment for AcoA aneurysms.