Potential therapeutic benefit of spinal cord stimulation in restless legs syndrome: scoping review and mechanistic considerations.

BACKGROUND: Restless legs syndrome (RLS) is a prevalent sensorimotor disorder that can dramatically impair sleep quality, daytime function, and quality of life. Although many patients benefit from standard pharmacological therapy, some patients suffer from insufficient treatment response or medication intolerance. Novel treatment approaches are therefore necessary. OBJECTIVE: Given the overlap between RLS and pain syndromes in both pathophysiological mechanisms and certain treatment options, we aimed to perform a scoping review of the available evidence on spinal cord stimulation (SCS) for RLS and discuss potential mechanistic implications. METHODS: We identified a total of 16 cases of patients with RLS who underwent SCS, all from case reports or case series. DISCUSSION: The published evidence is insufficient to assess SCS efficacy in patients with RLS, but SCS remains a promising investigational therapy in RLS on the basis of its potential mitigatory effects in the central hyperexcitability of the sensorimotor cortex through neuromodulation of spinal, subcortical, and cortical areas. A call for further research in this field is presented, with suggestions for future directions and trial designs.

Hematoma-induced Twiddler-like phenomenon as a presentation of DBS hardware failure: Case report.

Deep brain stimulators (DBS) may fail for a multitude of reasons. We present a 79-year-old Parkinson's disease patient who suffered a DBS failure following impulse generator (IPG) replacement surgery due to the IPG flipping within an expanded capsular pocket. This creation of the pocket was unintentional, and the pocket formed around an undiagnosed postoperative hemorrhage. The syndrome could be considered "Twiddler-like" because it resulted in device flipping. There were, however, many characteristic differences between our case and classical Twiddler's syndrome. DBS neurostimulator failure due to hematoma induced device flipping should be suspected when device interrogation is impossible or there are abnormally high impedances across multiple DBS lead contacts. A plain film X-ray series should be ordered and can be useful in providing radiological evidence of device flipping. In cases like ours the extensive braiding encountered in Twiddler's syndrome may be absent. Anchoring the IPG to a deep fascial layer as well as the use of an antimicrobial pouch are two methods that may be employed to prevent or to treat this complication.

Identifying the therapeutic zone in globus pallidus deep brain stimulation for Parkinson's disease.

OBJECTIVE: The globus pallidus internus (GPI) has been demonstrated to be an effective surgical target for deep brain stimulation (DBS) treatment in patients with medication-refractory Parkinson's disease (PD). The ability of neurosurgeons to define the area of greatest therapeutic benefit within the globus pallidus (GP) may improve clinical outcomes in these patients. The objective of this study was to determine the best DBS therapeutic implantation site within the GP for effective treatment in PD patients. METHODS: The authors performed a retrospective review of 56 patients who underwent bilateral GP DBS implantation at their institution during the period from January 2015 to January 2020. Each implanted contact was anatomically localized. Patients were followed for stimulation programming for at least 6 months. The authors reviewed preoperative and 6-month postsurgery clinical outcomes based on data from the Unified Parkinson's Disease Rating Scale Part III (UPDRS III), dyskinesia scores, and levodopa equivalent daily dose (LEDD). RESULTS: Of the 112 leads implanted, the therapeutic cathode was most frequently located in the lamina between the GPI external segment (GPIe) and the GP externus (GPE) (n = 40). Other common locations included the GPE (n = 24), the GPIe (n = 15), and the lamina between the GPI internal segment (GPIi) and the GPIe (n = 14). In the majority of patients (73%) a monopolar programming configuration was used. At 6 months postsurgery, UPDRS III off medications (OFF) and on stimulation (ON) scores significantly improved (z = -4.02, p < 0.001), as did postsurgery dyskinesia ON scores (z = -4.08, p < 0.001) and postsurgery LEDD (z = -4.7, p < 0.001). CONCLUSIONS: Though the ventral GP (pallidotomy target) has been a commonly used target for GP DBS, a more dorsolateral target may be more effective for neuromodulation strategies. The assessment of therapeutic contact locations performed in this study showed that the lamina between GPI and GPE used in most patients is the optimal central stimulation target. This information should improve preoperative GP targeting.

Management of Cerebral Herniation Secondary to Lead Encephalopathy: A Case Report.

Background: Adult lead encephalopathy is a rare but critical condition to recognize in modern healthcare settings. Few reports have described the medical and neurosurgical management of severe adult lead encephalopathy. Case Presentation: A 22 year old woman presented with severe headache, anemia, vomiting, 40-lb weight loss, and constipation. At the time of presentation, she had extensive colonic radiopaque material and a serum lead concentration of 87 mcg/dl (normal <10). She rapidly developed anisocoria requiring emergent ventriculostomy insertion. Following CSF diversion, ICP mitigation, and lead chelation, she considerably improved in <2 weeks. Conclusion: We report one of the few instances of successful surgical and medical management of adult lead encephalopathy. Dedicated neurocritical care and neurosurgical teams are necessary in conjunction with toxicology in order to manage the advanced sequalae of severe lead poisoning.

A novel local field potential-based functional approach for targeting the centromedian-parafascicular complex for deep brain stimulation.

BACKGROUND: The centromedian-parafascicular (Cm-Pf) complex of the thalamus is a common deep brain stimulation (DBS) target for treatment of Tourette syndrome (TS). Currently, there are no standardized functional intraoperative neurosurgical targeting approaches. Collectively, these issues have led to variability in DBS lead placement. Therefore, more defined methods are needed to improve targeting accuracy. OBJECTIVE: The objective of this observational study was to develop and to verify a functional mapping task capable of differentiating the Cm-Pf region from the nearby ventral intermediate (Vim) nucleus region of the thalamus. The overarching goal was to improve the reproducibility of DBS targeting in the Cm-Pf region. METHODS: Seven TS patients completed a modified Go/NoGo task (five in the post-operative setting and two in the intra-operative setting). Post-operative neural signals from Cm-Pf region were collected using sensing-enabled implanted neural stimulators, and intraoperative neural signals from the Cm-Pf region were collected using an external amplifier. Event-related potential (ERP) features were identified by using the grand-average of stimulus onset signals derived from the postoperative participants. These features were correlated with anatomical locations for the specific electrode recordings. The same features were extracted from the intraoperative patients in order to verify electrode positions in the operating room environment. RESULTS: Two features - a positive and a negative deflection - were identified in the average ERP from the post-operative participants. The peak amplitudes of both features were significantly correlated with the electrode depth position (p = 0.025 for positive deflection and p = 0.039 for negative deflection). The same result was reproduced intra-operatively in the two most recent patients, where more ventral electrode contacts revealed stronger peak amplitudes in comparison to the dorsal electrode contacts. CONCLUSION: This process was used to physiologically confirm accurate lead placement in the operating room setting. The modified Go/NoGo task elicited robust neural responses in the Cm-Pf region however the signal was not present in the Vim nucleus region of thalamus along the DBS electrode trajectory. We conclude that the differences in ERP responses may be a potentially novel LFP based functional approach for future targeting of the Cm-Pf complex for TS DBS.

Hidden Error in Optical Stereotactic Navigation Systems and Strategy to Maximize Accuracy.

BACKGROUND: Optical neuronavigation has been established as a reliable and effective adjunct to many neurosurgical procedures. Operations such as asleep deep brain stimulation (aDBS) benefit from the potential increase in accuracy that these systems offer. Built into these technologies is a degree of tolerated error that may exceed the presumed accuracy resulting in suboptimal outcomes. OBJECTIVE: The objective of this study was to identify an underlying source of error in neuronavigation and determine strategies to maximize accuracy. METHODS: A Medtronic Stealth system (Stealth Station 7 hardware, S8 software, version 3.1.1) was used to simulate an aDBS procedure with the Medtronic Nexframe system. Multiple configurations and orientations of the Nexframe-Nexprobe system components were examined to determine potential sources of, and to quantify navigational error, in the optical navigation system. Virtual entry point and target variations were recorded and analyzed. Finally, off-plan error was recorded with the AxiEM system and visual observation on a phantom head. RESULTS: The most significant source of error was found to be the orientation of the reference marker plate configurations to the camera system, with the presentation of the markers perpendicular to the camera line of site being the most accurate position. Entry point errors ranged between 0.134 ± 0.048 and 1.271 ± 0.0986 mm in a complex, reproducible pattern dependent on the orientation of the Nexprobe reference plate. Target errors ranged between 0.311 ± 0.094 and 2.159 ± 0.190 mm with a similarly complex, repeatable pattern. Representative configurations were tested for physical error at target with errors ranging from 1.2 mm to 1.4 mm. Throughout data acquisition, no orientation was indicated as outside the acceptable tolerance by the Stealth software. CONCLUSIONS: Use of optical neuronavigation is expected to increase in frequency and variety of indications. Successful implementation of this technology depends on understanding the tolerances built into the system. In situations that depend on extremely high precision, surgeons should familiarize themselves with potential sources of error so that systems may be optimized beyond the manufacturer's built-in tolerances. We recommend that surgeons align the navigation reference plate and any optical instrument's reference plate spheres in the plane perpendicular to the line of site of the camera to maximize accuracy.

Dissociation between reduced pain and arterial blood pressure following epidural spinal cord stimulation in patients with chronic pain: A retrospective study.

PURPOSE: Acute pain and resting arterial blood pressure (BP) are positively correlated in patients with chronic pain. However, it remains unclear whether treatment for chronic pain reduces BP. Therefore, in a retrospective study design, we tested the hypothesis that implantation of an epidural spinal cord stimulator (SCS) device to treat chronic pain would significantly reduce clinic pain ratings and BP and that these reductions would be significantly correlated. METHODS: Pain ratings and BP in medical records were collected before and after surgical implantation of a SCS device at the University of Iowa Hospitals and Clinics between 2008 and 2018 (n = 213). RESULTS: Reductions in pain rating [6.3 ± 2.0 vs. 5.0 ± 1.9 (scale: 0-10), P < 0.001] and BP [mean arterial pressure (MAP) 95 ± 10 vs. 89 ± 10 mmHg, P < 0.001] were statistically significant within 30 days of SCS. Interestingly, BP returned toward baseline within 60 days following SCS implantation. Multiple linear regression analysis showed that sex (P = 0.007), baseline MAP (P < 0.001), and taking hypertension (HTN) medications (P < 0.001) were significant determinants of change in MAP from baseline (Δ MAP) (model R2 = 0.33). After statistical adjustments, Δ MAP was significantly greater among women than among men ( - 7.2 ± 8.5 vs. - 3.9 ± 8.5 mmHg, P = 0.007) and among patients taking HTN medications than among those not taking hypertension medications ( - 10.1 ± 8.7 vs. - 3.9 ± 8.5 mmHg, P < 0.001), despite no group differences in change in pain ratings. CONCLUSIONS: Together, these findings suggest that SCS for chronic pain independently produces clinically meaningful, albeit transient, reductions in BP and may provide a rationale for studies aimed at reducing HTN medication burden among this patient population.

Globus Pallidus Internus (GPi) Deep Brain Stimulation for Parkinson's Disease: Expert Review and Commentary.

INTRODUCTION: The globus pallidus internus (GPi) region has evolved as a potential target for deep brain stimulation (DBS) in Parkinson's disease (PD). DBS of the GPi (GPi DBS) is an established, safe and effective method for addressing many of the motor symptoms associated with advanced PD. It is important that clinicians fully understand this target when considering GPi DBS for individual patients. METHODS: The literature on GPi DBS in PD has been comprehensively reviewed, including the anatomy, physiology and potential pitfalls that may be encountered during surgical targeting and post-operative management. Here, we review and address the implications of lead location on GPi DBS outcomes. Additionally, we provide a summary of randomized controlled clinical trials conducted on DBS in PD, together with expert commentary on potential applications of the GPi as target. Finally, we highlight future technologies that will likely impact GPi DBS, including closed-loop adaptive approaches (e.g. sensing-stimulating capabilities), advanced methods for image-based targeting and advances in DBS programming, including directional leads and pulse shaping. RESULTS: There are important disease characteristics and factors to consider prior to selecting the GPi as the DBS target of PD surgery. Prior to and during implantation of the leads it is critical to consider the neuroanatomy, which can be defined through the combination of image-based targeting and intraoperative microelectrode recording strategies. There is an increasing body of literature on GPi DBS in patients with PD suggesting both short- and long-term benefits. Understanding the GPi target can be useful in choosing between the subthalamic (STN), GPi and ventralis intermedius nucleus as lead locations to address the motor symptoms and complications of PD. CONCLUSION: GPi DBS can be effectively used in select cases of PD. As the ongoing DBS target debate continues (GPi vs. STN as DBS target), clinicians should keep in mind that GPi DBS has been shown to be an effective treatment strategy for a variety of symptoms, including bradykinesia, rigidity and tremor control. GPi DBS also has an important, direct anti-dyskinetic effect. GPi DBS is easier to program in the outpatient setting and will allow for more flexibility in medication adjustments (e.g. levodopa). Emerging technologies, including GPi closed-loop systems, advanced tractography-based targeting and enhanced programming strategies, will likely be future areas of GPi DBS expansion. We conclude that although the GPi as DBS target may not be appropriate for all PD patients, it has specific clinical advantages.

Lead Repositioning Guided by Both Physiology and Atlas Based Targeting in Tourette Deep Brain Stimulation.

Background: The centromedian (CM) region of the thalamus is a common target for deep brain stimulation (DBS) treatment for Tourette Syndrome (TS). However, there are currently no standard microelectrode recording or macrostimulation methods to differentiate CM thalamus from other nearby structures and nuclei. Case Report: Here we present a case of failed conventional stereotactic targeting in TS DBS. Postoperative local field potential recordings (LFPs) showed features including beta power desynchronization during voluntary movement and thalamo-cortical phase amplitude coupling at rest. These findings suggested that the DBS lead was suboptimally placed in the ventral intermediate (VIM) nucleus of the thalamus rather than the intended CM region. Due to a lack of clinical improvement in tic severity scales three months following the initial surgery, the patient underwent lead revision surgery. Slight repositioning of the DBS leads resulted in a remarkably different clinical outcome. Afterwards, LFPs revealed less beta desynchronization and disappearance of the thalamo-cortical phase amplitude coupling. Follow-up clinical visits documented improvement of the patient's global tic scores. Discussion: This case provides preliminary evidence that combining physiology with atlas based targeting may possibly enhance outcomes in some cases of Tourette DBS. A larger prospective study will be required to confirm these findings. Highlight: This report demonstrates a case of failed centromedian nucleus region deep brain stimulation (DBS). We observed suboptimal tic improvement several months following DBS surgery and subsequent lead revision improved the outcome. The neurophysiology provided an important clue suggesting the possibility of suboptimally placed DBS leads. Repeat LFPs during lead revision revealed less beta desynchronization and disappearance of the thalamo-cortical phase amplitude coupling. There was improvement in tic outcome following slight repositioning during bilateral DBS lead revision. This case provides preliminary evidence supporting the use of physiology to augment the atlas based targeting of Tourette DBS cases.

Spinal Cord Stimulation for Visceral Pain: Present Approaches and Future Strategies.

INTRODUCTION: The introduction of successful neuromodulation strategies for managing chronic visceral pain lag behind what is now treatment of choice in refractory chronic back and extremity pain for many providers in the United States and Europe. Changes in public policy and monetary support to identify nonopioid treatments for chronic pain have sparked interest in alternative options. In this review, we discuss the scope of spinal cord stimulation (SCS) for visceral pain, its limitations, and the potential role for new intradural devices of the type that we are developing in our laboratories, which may be able to overcome existing challenges. METHODS: A review of the available literature relevant to this topic was performed, with particular focus on the pertinent neuroanatomy and uses of spinal cord stimulation systems in the treatment of malignant and nonmalignant gastrointestinal, genitourinary, and chronic pelvic pain. RESULTS: To date, there have been multiple off-label reports testing SCS for refractory gastrointestinal and genitourinary conditions. Though some findings have been favorable for these organs and systems, there is insufficient evidence to make this practice routine. The unique configuration and layout of the pelvic pain pathways may not be ideally treated using traditional SCS implantation techniques, and intradural stimulation may be a viable alternative. CONCLUSIONS: Despite the prevalence of visceral pain, the application of neuromodulation therapies, a standard approach for other painful conditions, has received far too little attention, despite promising outcomes from uncontrolled trials. Detailed descriptions of visceral pain pathways may offer several clues that could be used to implement devices tailored to this unique anatomy.

Intervertebral Displacement of the Thoracic Spine with and without Loading: Radiographic and in Vitro Measurements.

BACKGROUND: We are developing an intradural approach to spinal cord stimulation, where the thin electrode array is affixed stably to the underside of the thoracic spinal dura mater without leakage of cerebrospinal fluid. As part of the design and testing process, we sought to evaluate the potential risk of inadvertent contact of the array with the pial surface of the spinal cord during variations in spinal loading. METHODS: As part of the risk assessment process, a 2-part study was undertaken. First, a retrospective review of the imaging studies of 25 patients was done in the supine, 45- and 90-degree positions to measure the positional shift between the T9 and T10 vertebral bodies as a function of spinal angulation. Second, similar measurements were made on a cadaveric model, with and without a prototype intradural stimulator implanted at the T9-T10 position and with and without 13.8 kg (30 lb) of axial spinal loading at the 90-degree orientation. RESULTS: In all cases, the measured relative displacement of the dura mater towards the spinal cord in both the imaging and the cadaveric arms of the study was less than 1 mm. CONCLUSIONS: The implantation method for the thin intradural array of the prototype device will ensure that the anatomic separation between it and the pial surface of the spinal cord will be the same as that of the dura mater. Therefore the risk of inadvertent contact will be no greater than that due to the mass effects of standard epidural stimulator implants.

Deep Brain Stimulation for Obsessive-Compulsive Disorder: A Long Term Naturalistic Follow Up Study in a Single Institution.

INTRODUCTION: Deep brain stimulation (DBS) is a proven, effective tool in the treatment of movement disorders. Expansion of indications for DBS into the realm of neuropsychiatric disorders, especially obsessive-compulsive disorder (OCD), has gained fervent interest, although data on appropriate clinical utilization remains limited. METHODS: A retrospective, naturalistic study followed nine severely affected OCD patients (average YBOCs score before implantation 34.2 ± 2.5) treated with DBS of ventral capsule/ventral striatum, with average follow up of 54.8 months. RESULTS: With chronic stimulation (years), a majority of the patients achieved significant benefits in obsessive-compulsive and depressive symptoms. Six patients experienced periods of OCD remission following implantation. Four of the six responders required more than 12 months to achieve response. Relief of major depressive symptoms occurred in four out of six patients with documented co-morbid depression. Settings required to achieve efficacy were higher than those typically utilized for movement disorders, necessitating increased impulse generator (IPG) battery demand. We found patients benefited from conversion to a rechargeable IPG to prevent serial operations for IPG replacement. For patients with rechargeable IPGs, the repetitive habit of recharging did not appear to aggravate or trigger new obsessive-compulsive behaviors or anxiety symptoms. CONCLUSIONS: Our study supports and builds upon other research suggesting that DBS for OCD in a real-world setting can be implemented successfully and provide long-term benefit for severely affected OCD patients. Optimal patient selection and DBS programming criteria are discussed. The use of rechargeable IPGs appears to be both cost effective and well-tolerated in this population.

In Vivo Testing of a Prototype Intradural Spinal Cord Stimulator in a Porcine Model.

BACKGROUND: Chronic midline low back pain is the number one reason for disability in the United States despite the prolific use of medical and surgical interventions. Notwithstanding the widespread use of epidural spinal cord stimulators (SCSs), there remains a large portion of the population with inadequate pain control thought to be because of the limited volume of stimulated neural tissue. Intradural SCSs represent an underexplored alternative strategy with the potential to improve selectivity, power efficiency, and efficacy. We studied and carried out development of an intradural form of an SCS. Herein we present the findings of in vivo testing of a prototype intradural SCS in a porcine model. METHODS: Six female juvenile pigs underwent surgical investigation. One control animal underwent a laminectomy only, whereas the 5 other animals had implantation of an intradural SCS prototype. One of the prototypes was fully wired to enable acute stimulation and concurrent electromyographic recordings. All animals underwent terminal surgery 3 months postimplantation, with harvesting of the spinal column. Imaging (microcomputed tomography scan) and histopathologic examinations were subsequently performed. RESULTS: All animals survived implantation without evidence of neurologic deficits or infection. Postmortem imaging and histopathologic examination of the spinal column revealed no evidence of spinal cord damage, cerebrospinal fluid fistula formation, abnormal bony overgrowth, or dural defect. Viable dura was present between the intra- and extradural plates of the device. Electromyographic recordings revealed evoked motor units from the stimulator. CONCLUSIONS: Chronically implanted intradural device in the porcine model demonstrated safety and feasibility for translation into humans.

Many caregivers of persons with memory loss or Alzheimer's disease are unaware of the abilities of their persons with AD to recall their drugs and medical histories.

BACKGROUND: Caregiver awareness of the abilities of those they care for has much practical importance, especially from the safety standpoint. OBJECTIVES: To determine whether the caregivers of persons with memory impairment or Alzheimer's disease know if their persons are able to recall their own drugs and medical histories. METHOD: Persons with prodromal or probable AD (persons with AD) and their caregivers who were visiting our medical school's neurology and internal medicine clinics for routine follow-up care were recruited on the days of their appointments. Sixty-four caregiver-person with AD dyads were recruited. We first asked the caregivers to predict the ability of their persons with AD to answer questions about their drugs and medical histories. We then asked the persons with AD the questions to determine the accuracy of their caregivers' predictions. RESULTS: Considering the caregivers of those with Mini-Mental State Exam scores ≥24, 41% incorrectly predicted whether their persons with AD could recall the number of drugs they were taking, 24% incorrectly predicted whether they could recall the names of the drugs, and 34% incorrectly predicted whether they could recall why they were taking the drugs. Most of the caregivers' errors were overestimations. As expected, the persons with AD themselves had much difficulty in answering the questions; only 30% could recall the number of drugs they were taking, only 14% could recall the names of the drugs, and only 16% could recall why they were taking the drugs. CONCLUSIONS: Many caregivers of persons with memory impairment or AD are unaware of their persons' inability to recall their drugs and medical histories. Particularly concerning is the relatively high frequency of caregiver overestimations of the abilities of their persons with AD, which highlights a safety concern and presents an opportunity for caregiver education.

A new device to improve target localization for transcranial magnetic stimulation therapy.

BACKGROUND: Accurate identification of cranial midline structures is essential for many targeting techniques that use repetitive transcranial magnetic stimulation (rTMS), including the Beam F3 method used for depression treatment. OBJECTIVE: Evaluate whether a novel, laser-sighted device will assist with more accurate identification of the cranial midline relative to standard scalp-based measurement procedures. METHODS: Three trained TMS technicians performed repeated scalp-based measurements to identify the inion and vertex on five subjects (n = 54 measurements). Measurements were compared to points identified with the midline localizer device and the true midline as defined by MRI midline structures. RESULTS: Use of the midline localizer was more accurate for midline identification than technician measurement (p = 0.00025) and the ratio of localizing the midline within 5 mm was higher (78% versus 54%, p = 0.008). CONCLUSION: Use of a laser-sighted midline localizer device can improve the accuracy of scalp measurements associated with target localization for rTMS treatment protocols.

Predictability of vascular conflict by MRI in trigeminal neuralgia.

OBJECTIVE: Magnetic resonance imaging (MRI) has been investigated extensively in its success or failure to identify preoperative vascular compression in patients with trigeminal neuralgia (TN). To this end, we reviewed our case load to evaluate the concordance or discordance between preoperative MRI and intraoperative findings. PATIENTS AND METHODS: Sixty-nine patients with Type 1 TN and retrievable MRI images, operative reports, and intraoperative photographs were retrospectively reviewed. RESULTS: Our review shows that MRI predicted conflict (arterial or venous) in 58 cases that was confirmed at surgery in 55 cases. MRI predicted no conflict in 11 cases, whereas surgery revealed no conflict in a total of 6 cases. Thus, in predicting conflict at surgery, MRI had a sensitivity of 87%, and specificity of 50%, respectively. Conversely, MRI accurately predicted intraoperative conflict (positive predictive value) in 95% of cases, and the absence of conflict (negative predictive value) in 27%. These results reveal that MRI is more accurate in predicting conflict than the absence of conflict at surgery. CONCLUSION: Our results support the reliance on the clinical diagnosis of Type 1 TN to recommend microvascular decompression (MVD). The presence of vascular compression by MRI should encourage the surgeon to persevere in search of the offending vessel when it proves elusive. MRI positive and negative predictive values for conflict are expected to increase with better resolution imaging. The absence of neurovascular conflict on high-resolution MRI should not negate MVD in the treatment of a patient with classic TN.

The Wishbone: A Cranial Midline Localizing Device.

OBJECTIVE: The Wishbone device is designed to enable surgeons to quickly and accurately localize the cranial midline. It is intended to be of particular use when localizing the burr hole site during posterior ventriculoperitoneal shunt (VPS) surgery. METHODS: The Wishbone is a simple mechanical device with 2 adjustable caliper arms that reversibly attach to a patient's left and right external auditory canals. The Wishbone's laser localizer illuminates the midline scalp. The Wishbone was used to localize the posterior midline in a pilot series of patients undergoing VPS surgery. Midline localization and ventricular catheter placement accuracy were determined using findings from postoperative computed tomography scans. RESULTS: The Wishbone is a mechanically robust device and proved easy for surgeons to use. Forty patients underwent VPS surgery using the Wishbone to localize the posterior midline. The localization procedure took less than 3 minutes. The average distance separating the Wishbone-localized midline scalp location and the computed tomography-defined anatomical midline was 2.9 mm (95% confidence interval 1.6-4.1 mm). In all cases, the ventricular catheter entered the ipsilateral lateral ventricle. The catheter tips were placed in the ipsilateral (n = 34) or contralateral (n = 5) frontal horn in all but 1 patient. In 1 patient, the catheter tip entered the parenchyma due to a burr hole localization error in the rostrocaudal dimension, unrelated to the Wishbone. CONCLUSIONS: We describe a simple, efficient, and cost-effective system for accurately localizing the posterior cranial midline. A larger patient series is required to definitively compare its clinical utility relative to frameless stereotaxis-based midline localization methods.

Intradural Spinal Cord Stimulation: Performance Modeling of a New Modality.

Introduction: Intradural spinal cord stimulation (SCS) may offer significant therapeutic benefits for those with intractable axial and extremity pain, visceral pain, spasticity, autonomic dysfunction and related disorders. A novel intradural electrical stimulation device, limited by the boundaries of the thecal sac, CSF and spinal cord was developed to test this hypothesis. In order to optimize device function, we have explored finite element modeling (FEM). Methods: COMSOL®Multiphysics Electrical Currents was used to solve for fields and currents over a geometric model of a spinal cord segment. Cathodic and anodic currents are applied to the center and tips of the T-cross component of the electrode array to shape the stimulation field and constrain charge-balanced cathodic pulses to the target area. Results: Currents from the electrode sites can move the effective stimulation zone horizontally across the cord by a linear step method, which can be diversified considerably to gain greater depth of penetration relative to standard epidural SCS. It is also possible to prevent spread of the target area with no off-target action potential. Conclusion: Finite element modeling of a T-shaped intradural spinal cord stimulator predicts significant gains in field depth and current shaping that are beyond the reach of epidural stimulators. Future studies with in vivo models will investigate how this approach should first be tested in humans.

Durotomy Surrogate and Seals for Intradural Spinal Cord Stimulators: Apparatus and Review of Clinical Methods and Materials.

INTRODUCTION: We are developing a novel intradural spinal cord stimulator for treatment of neuropathic pain and spasticity. A key feature is the means by which it seals the dura mater to prevent leakage of cerebrospinal fluid (CSF). We have built and employed a test rig that enables evaluation of candidate seal materials. METHODS: To guide the design of the test rig, we reviewed the literature on neurosurgical durotomies. The test rig has a mock durotomy slot with a dural substitute serving as the surrogate dura mater and water as the CSF. The primary experimental goal was to evaluate the effectiveness of candidate gasket materials as seals against CSF leakage in an implanted prototype device, at both normal and super-physiologic pressures. A secondary goal was to measure the transmembrane flows in a representative dural substitute material, to establish its baseline aqueous transport properties. RESULTS: The seals prevented leakage of water at the implantation site over periods of ≈ ten days, long enough for the scar tissue to form in the clinical situation. The seals also held at water pressure transients approaching 250 mm Hg. The residual volumetric flux of water through the dura substitute membrane (Durepair®) was δVT /A ≈ 0.24 mm3 /min/cm2 , consistent with expectations for transport through the porous membrane prior to closure and equalization of internal/external pressures. CONCLUSIONS: We have demonstrated the workability of obtaining robust seal against leakage at the implantation site of a novel intradural stimulator using a custom-designed test rig. Extension of the method to in vivo testing in a large animal model will be the next step.