Lumbar Facet Arthroplasty Versus Fusion for Grade-I Degenerative Spondylolisthesis with Stenosis: A Prospective Randomized Controlled Trial.

BACKGROUND: The comparative effectiveness of decompression plus lumbar facet arthroplasty versus decompression plus instrumented lumbar spinal fusion in patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis is unknown. METHODS: In this randomized, controlled, Food and Drug Administration Investigational Device Exemption trial, we assigned patients who had single-level lumbar spinal stenosis and grade-I degenerative spondylolisthesis to undergo decompression plus lumbar facet arthroplasty (arthroplasty group) or decompression plus fusion (fusion group). The primary outcome was a predetermined composite clinical success score. Secondary outcomes included the Oswestry Disability Index (ODI), visual analog scale (VAS) back and leg pain, Zurich Claudication Questionnaire (ZCQ), Short Form (SF)-12, radiographic parameters, surgical variables, and complications. RESULTS: A total of 321 adult patients were randomized in a 2:1 fashion, with 219 patients assigned to undergo facet arthroplasty and 102 patients assigned to undergo fusion. Of these, 113 patients (51.6%) in the arthroplasty group and 47 (46.1%) in the fusion group who had either reached 24 months of postoperative follow-up or were deemed early clinical failures were included in the primary outcome analysis. The arthroplasty group had a higher proportion of patients who achieved composite clinical success than did the fusion group (73.5% versus 25.5%; p < 0.001), equating to a between-group difference of 47.9% (95% confidence interval, 33.0% to 62.8%). The arthroplasty group outperformed the fusion group in most patient-reported outcome measures (including the ODI, VAS back pain, and all ZCQ component scores) at 24 months postoperatively. There were no significant differences between groups in surgical variables or complications, except that the fusion group had a higher rate of developing symptomatic adjacent segment degeneration. CONCLUSIONS: Among patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis, lumbar facet arthroplasty was associated with a higher rate of composite clinical success than fusion was at 24 months postoperatively. LEVEL OF EVIDENCE: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

Movement disorder Deep brain stimulation Hybridization: Patient and caregiver outcomes.

Background and Objectives: Deep brain stimulation (DBS) is a well-established surgical treatment for certain movement disorders and involves the implantation of brain electrodes connected to implantable pulse generators (IPGs). As more device manufacturers have entered the market, some IPG technology has been designed to be compatible with brain electrodes from other manufacturers, which has facilitated the hybridization of implant technology. The aim of this study was to assess the benefits of hybridization of non-rechargeable, constant voltage IPGs to rechargeable, constant current IPGs. Methods: A list of DBS movement disorder patients who had their non-rechargeable, constant voltage IPGs replaced with rechargeable, constant current IPGs from a different manufacturer was compiled. Structured surveys of these patients, and their caregivers when applicable, were undertaken to determine both patient and caregiver satisfaction in this DBS hybridization strategy. Results: Eighteen patients met inclusion criteria and twelve patients or their caregivers completed the structured survey (67% response rate). Nine patients had Parkinson's disease (75%), three had essential tremor (25%). Nine (75%) were converted from bilateral single-channel IPGs, and three (25%) were converted from a unilateral dual-channel IPGs. Overall, 92% of patients and caregivers surveyed reported improvement or no change in their symptoms, 92% reported a decrease or no change in their medication requirements, and 92% report they are satisfied or very satisfied with their IPG hybridization and would recommend the surgery to similar patients. There were no immediate surgical complications. Conclusion: In this series of movement disorder DBS patients, surgery was safe and patient and caregiver satisfaction were high with a hybridization of non-rechargeable, constant voltage IPGs to rechargeable, constant current IPGs.

A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Results from the Total Posterior Spine System (TOPS) IDE Study.

STUDY DESIGN: Prospective randomized Food and Drug Administration investigational device exemption clinical trial. OBJECTIVE: The purpose of the present study is to report the 1-year clinical and radiographic outcomes and safety profile of patients who underwent lumbar facet arthroplasty through implantation of the Total Posterior Spine System (TOPS) device. SUMMARY OF BACKGROUND DATA: Lumbar facet arthroplasty is one proposed method of dynamic stabilization to treat grade-1 spondylolisthesis with stenosis; however, there are currently no Food and Drug Administration-approved devices for facet arthroplasty. METHODS: Standard demographic information was collected for each patient. Radiographic parameters and patient-reported outcome measures were assessed preoperatively and at regular postoperative intervals. Complication and reoperation data were also collected for each patient. RESULTS: At the time of this study, 153 patients had undergone implantation of the TOPS device. The mean surgical time was 187.8 minutes and the mean estimated blood loss was 205.7cc. The mean length of hospital stay was 3.0 days. Mean Oswestry Disability Index, Visual Analog Score leg and back, and Zurich Claudication Questionnaire scores improved significantly at all postoperative time points ( P >0.001). There were no clinically significant changes in radiographic parameters, and all operative segments remained mobile at 1-year follow-up. Postoperative complications occurred in 11 patients out of the 153 patients (7.2%) who underwent implantation of the TOPS device. Nine patients (5.9%) underwent a total of 13 reoperations, 1 (0.6%) of which was for device-related failure owing to bilateral L5 pedicle screw loosening. CONCLUSIONS: Lumbar facet arthroplasty with the TOPS device demonstrated a statistically significant improvement in all patient-reported outcome measures and the ability to maintain motion at the index level while limiting sagittal translation with a low complication rate.

Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis.

OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy of a posterior facet replacement device, the Total Posterior Spine (TOPS) System, for the treatment of one-level symptomatic lumbar stenosis with grade I degenerative spondylolisthesis. Posterior lumbar arthroplasty with facet replacement is a motion-preserving alternative to lumbar decompression and fusion. The authors report the preliminary results from the TOPS FDA investigational device exemption (IDE) trial. METHODS: The study was a prospective, randomized controlled FDA IDE trial comparing the investigational TOPS device with transforaminal lumbar interbody fusion (TLIF) and pedicle screw fixation. The minimum follow-up duration was 24 months. Validated patient-reported outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain. The primary outcome was a composite measure of clinical success: 1) no reoperations, 2) no device breakage, 3) ODI reduction of ≥ 15 points, and 4) no new or worsening neurological deficit. Patients were considered a clinical success only if they met all four measures. Radiographic assessments were made by an independent core laboratory. RESULTS: A total of 249 patients were evaluated (n = 170 in the TOPS group and n = 79 in the TLIF group). There were no statistically significant differences between implanted levels (L4-5: TOPS, 95% and TLIF, 95%) or blood loss. The overall composite measure for clinical success was statistically significantly higher in the TOPS group (85%) compared with the TLIF group (64%) (p = 0.0138). The percentage of patients reporting a minimum 15-point improvement in ODI showed a statistically significant difference (p = 0.037) favoring TOPS (93%) over TLIF (81%). There was no statistically significant difference between groups in the percentage of patients reporting a minimum 20-point improvement on VAS back pain (TOPS, 87%; TLIF, 64%) and leg pain (TOPS, 90%; TLIF, 88%) scores. The rate of surgical reintervention for facet replacement in the TOPS group (5.9%) was lower than the TLIF group (8.8%). The TOPS cohort demonstrated maintenance of flexion/extension range of motion from preoperatively (3.85°) to 24 months (3.86°). CONCLUSIONS: This study demonstrates that posterior lumbar decompression and dynamic stabilization with the TOPS device is safe and efficacious in the treatment of lumbar stenosis with degenerative spondylolisthesis. Additionally, decompression and dynamic stabilization with the TOPS device maintains segmental motion.

Bilateral pallidal DBS for blepharospasm: A case report and review of the literature.

Background: Deep brain stimulation (DBS) of the globus pallidus internus (GPi) in the treatment of craniocervical dystonia often requires an extended period of stimulation parameter manipulations. Case Description: We present a patient suffering from debilitating blepharospasm treated with bilateral DBS of the GPi alongside 7 years of stimulation parameter manipulations and a literature review of comparable patients. Conclusion: Our literature review suggests that a patient's specific dystonic symptoms can guide stimulation parameter manipulations. Further research regarding trends in stimulation parameters being used in the field for different dystonic symptoms may expedite the stimulation parameter manipulation process.

Development and Characterization of Novel Conductive Sensing Fibers for In Vivo Nerve Stimulation.

Advancements in electrode technologies to both stimulate and record the central nervous system's electrical activities are enabling significant improvements in both the understanding and treatment of different neurological diseases. However, the current neural recording and stimulating electrodes are metallic, requiring invasive and damaging methods to interface with neural tissue. These electrodes may also degrade, resulting in additional invasive procedures. Furthermore, metal electrodes may cause nerve damage due to their inherent rigidity. This paper demonstrates that novel electrically conductive organic fibers (ECFs) can be used for direct nerve stimulation. The ECFs were prepared using a standard polyester material as the structural base, with a carbon nanotube ink applied to the surface as the electrical conductor. We report on three experiments: the first one to characterize the conductive properties of the ECFs; the second one to investigate the fiber cytotoxic properties in vitro; and the third one to demonstrate the utility of the ECF for direct nerve stimulation in an in vivo rodent model.

Headache as a Presenting Symptom of Deep Brain Stimulator Generator Failure.

While a headache can have a wide variety of clinical presentations, it may occasionally be a red flag for underlying pathology that should prompt further investigation. Here, we present a case report demonstrating headache as an uncommon symptom of deep brain stimulation (DBS) device failure and discuss its clinical significance in the rapidly expanding list of current indications of DBS treatment. A 61-year-old female underwent bilateral hypothalamic DBS implantation for refractory morbid obesity. After a successful course involving significant weight loss, the patient began to experience worsening of her chronic headaches, refractory to her existing regiment. On interrogation, her generator was found to be depleted and its subsequent replacement led to a near total resolution of her headaches. This represents one of the few reported instances of headache as a sign of device failure in DBS treatment, thus adding to the wide possibility of headache presentations and their underlying pathology.

Neurologic Complications in Monitored versus Unmonitored Image-Guidance Assisted Posterior Lumbar Instrumentation.

BACKGROUND: Intraoperative neurophysiologic monitoring (IOM) has been used clinically since the 1970s and is a reliable tool for detecting impending neurologic compromise. However, there are mixed data as to whether long-term neurologic outcomes are improved with its use. We investigated whether IOM used in conjunction with image guidance produces different patient outcomes than with image guidance alone. METHODS: We reviewed 163 consecutive cases between January 2015 and December 2018 and compared patients undergoing posterior lumbar instrumentation with image guidance using and not using multimodal IOM. Monitored and unmonitored surgeries were performed by the same surgeons, ruling out variability in intersurgeon technique. Surgical and neurologic complication rates were compared between these 2 cohorts. RESULTS: A total of 163 patients were selected (110 in the nonmonitored cohort vs. 53 in the IOM cohort). Nineteen signal changes were noted. Only 3 of the 19 patients with signal changes had associated neurologic deficits postoperatively (positive predictive value 15.7%). There were 5 neurologic deficits that were observed in the nonmonitored cohort and 8 deficits observed in the monitored cohort. Transient neurologic deficit was significantly higher in the monitored cohort per case (P < 0.0198) and per screw (P < 0.0238); however, there was no difference observed between the 2 cohorts when considering permanent neurologic morbidity per case (P < 0.441) and per screw (P < 0.459). CONCLUSIONS: The addition of IOM to cases using image guidance does not appear to decrease long-term postoperative neurologic morbidity and may have a reduced diagnostic role given availability of intraoperative image-guidance systems.

Impact of Coronavirus Disease 2019 Shutdown on Neurotrauma Volume in Pennsylvania.

OBJECTIVE: The 2020 coronavirus disease 2019 (COVID-19) pandemic resulted in state-specific quarantine protocols and introduced the concept of social distancing into modern parlance. We assess the impact of the COVID-19 pandemic on neurotrauma presentations in the first 3 months after shutdown throughout Pennsylvania. METHODS: The Pennsylvania Trauma Systems Foundation was queried for registry data from the Pennsylvania Trauma Outcomes Study between March 12 and June 5 in each year from 2017 to 2020. RESULTS: After the COVID-19 shutdown, there was a 27% reduction in neurotrauma volume, from 2680 cases in 2017 to 2018 cases in 2020, and a 28.8% reduction in traumatic brain injury volume. There was no significant difference in neurotrauma phenotype incurred relative to total cases. Injury mechanism was less likely to be motor vehicle collision and more likely caused by falls, gunshot wound, and recreational vehicle accidents (P < 0.05). Location of injury was less likely on roads and public locations and more likely at indoor private locations (P < 0.05). The proportion of patients with neurotrauma with blood alcohol concentration >0.08 g/dL was reduced in 2020 (11.4% vs. 9.0%; P < 0.05). Mortality was higher during 2020 compared with pre-COVID years (7.7% vs. 6.4%; P < 0.05). CONCLUSIONS: During statewide shutdown, neurotrauma volume and alcohol-related trauma decreased and low-impact traumas and gunshot wounds increased, with a shift toward injuries occurring in private, indoor locations. These changes increased mortality. However, there was not a change in the types of injuries sustained.

Parametric evaluation of deep brain stimulation parameter configurations for Parkinson's disease using a conformal wearable and wireless inertial sensor system and machine learning.

Deep brain stimulation enables highly specified patient-unique therapeutic intervention ameliorating the symptoms of Parkinson's disease. Inherent to the efficacy of deep brain stimulation is the acquisition of an optimal parameter configuration. Using conventional methods, the optimization process for tuning the deep brain stimulation system parameters can intrinsically induce strain on clinical resources. An advanced means of quantifying Parkinson's hand tremor and distinguishing between parameter settings would be highly beneficial. The conformal wearable and wireless inertial sensor system, such as the BioStamp nPoint, has a volumetric profile on the order of a bandage that readily enables convenient quantification of Parkinson's disease hand tremor. Furthermore, the BioStamp nPoint has been certified by the FDA as a 510(k) medical device for acquisition of medical grade data. Parametric variation of the amplitude parameter for deep brain stimulation can be quantified through the BioStamp nPoint conformal wearable and wireless inertial sensor system mounted to the dorsum of the hand. The acquired inertial sensor signal data can be wirelessly transmitted to a secure Cloud computing environment for post-processing. The quantified inertial sensor data for the parametric study of the effects of varying amplitude can be distinguished through machine learning classification. Software automation through Python can consolidate the inertial sensor data into a suitable feature set format. Using the multilayer perceptron neural network considerable machine learning classification accuracy is attained to distinguish multiple parametric settings of amplitude for deep brain stimulation, such as 4.0 mA, 2.5 mA, 1.0 mA, and 'Off' status representing a baseline. These findings constitute an advance toward the pathway of attaining real-time closed loop automated parameter configuration tuning for treatment of Parkinson's disease using deep brain stimulation.

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.

Single-Surgeon Direct Comparison of O-arm Neuronavigation versus Mazor X Robotic-Guided Posterior Spinal Instrumentation.

OBJECTIVE: We sought to compare intraoperative surgical instrumentation techniques with image-guidance versus robotic-guided procedures for posterior spinal fusion. METHODS: A retrospective review of institutional data collected from a single surgeon was used to compare surgical outcomes between O-arm neuronavigation and the Mazor X robotic-assistance system for placement of posterior spinal instrumentation in a consecutive series of patients. Univariate statistical significance testing compared time spent in the operating room, blood loss, screw accuracy, and wound healing. RESULTS: Between January 2017 and February 2019, 46 O-arm cases (mean age 59.6 years ± 13.7 years) and 39 Mazor X cases (mean age 59.5 years ± 12.4 years) were conducted. Cases were classified as degenerative, infectious, oncologic, and trauma with a mean of 4.57 and 5.43 levels operated on using O-arm neuronavigation and Mazor X, respectively. Mean operative times (P = 0.124), estimated blood loss (P = 0.212), wound revision rates (P = 0.560), and clinically acceptable instrumentation placement (P = 0.076) did not demonstrate significance between the 2 groups. However, screw placement was significantly more accurate and precise (P = 1 × 10-9) with robotic assistance when considering Gertzbein-Robbins A placement. CONCLUSIONS: Although a trend toward greater accuracy was noticed with robotic technology when determining clinically acceptable screws, there was not a significant difference when compared with O-arm neuronavigation. However, robotic technology has a significant effect on both precision and accuracy in Gertzbein-Robbins A screw placement. Robotics does not have a clear advantage when discussing infection rates, intraoperative blood loss, or operative time.

Prevention of Implant-Associated Infection in Neuromodulation: Review of the Literature and Prototype of a Novel Protective Implant Coating.

Background: Implanting hardware into surgical sites increases the rate of infection associated with these sites. Without novel efforts to reduce this rate of infection, we can expect to see an increase in the number of hardware-associated infections as more patients are implanted with these devices. These infections often necessitate the removal of these devices resulting in a significant financial and clinical burden to patients. We developed a prototype antibiotic coating using products that are both low cost and that can be sourced easily. Our study aims to test the effectiveness of this coating against bacteria commonly observed in hospital-associated infections. Methods: The antibiotic coating was prepared by combining one gram of vancomycin and 500 mg of ciprofloxacin in 50 mL of glycerol. The coating was examined for inhibition of growth of Pseudomonas aeruginosa PA14 and Staphylococcus aureus AH2486 and compared with the bacterial growth of the above bacteria in glycerol alone. The growth curves were plotted measuring the bacterial growth at 5 h intervals. Results: The results of the growth curves clearly demonstrate a lack of bacterial growth when these bacteria are combined with glycerol combined with our selected antibiotic agents. Conclusion: There appears to be a limited interest from device companies in developing new strategies for infection prevention associated with neurosurgical hardware, and we propose that this prototype will be an effective and low-cost solution to a large problem.

Covalent Poly(lactic acid) Nanoparticles for the Sustained Delivery of Naloxone.

The opioid epidemic currently plaguing the United States has been exacerbated by an alarming rise in fatal overdoses as a result of the proliferated abuse of synthetic mu opioid receptor (MOR) agonists, such as fentanyl and its related analogues. Attempts to manage this crisis have focused primarily on widespread distribution of the clinically approved opioid reversal agent naloxone (Narcan); however, due to the intrinsic metabolic lability of naloxone, these measures have demonstrated limited effectiveness against synthetic opioid toxicity. This work reports a novel polymer-based strategy to create a long-acting formulation of naloxone with the potential to address this critical issue by utilizing covalent nanoparticle (cNP) drug delivery technology. Covalently loaded naloxone nanoparticles (Nal-cNPs) were prepared via the naloxone-initiated, ring-opening polymerization (ROP) of l-lactide in the presence of a bifunctional thiourea organocatalyst with subsequent precipitation of the resulting naloxone-poly(l-lactic acid) polymer. This protocol afforded well-defined nanoparticles possessing a drug loading of approximately 7% w/w. The resulting Nal-cNPs demonstrated excellent biocompatibility, while exhibiting sustained linear release kinetics in vitro and blocking the effects of high dose (10 mg/kg) acute morphine for up to 98 h in an in vivo rodent model of neuropathic pain.

Deep Brain Stimulation of the Hypothalamus Leads to Increased Metabolic Rate in Refractory Obesity.

OBJECTIVE: Obesity has become a worldwide epidemic, with very few long-term successful treatment options for refractory disease. Deep brain stimulation (DBS) of the bilateral lateral hypothalamus (LH) in refractory obesity has been performed safely. However, questions remain regarding the optimal settings and its effects on metabolic rate. The goals of our experiment were to determine the optimal DBS settings and the actual effect of optimal stimulation on energy expenditure. METHODS: After bilateral LH DBS implantation, 2 subjects with treatment refractory obesity underwent 4 days of metabolic testing. The subjects slept overnight in a respiratory chamber to measure their baseline sleep energy expenditure, followed by 4 consecutive days of resting metabolic rate (RMR) testing at different stimulation settings. On day 4, the optimized DBS settings were used, and sleep energy expenditure was measured again overnight in the room calorimeter. RESULTS: During daily testing, the RMR fluctuated acutely with changes in stimulation settings and returned to baseline immediately after turning off the stimulation. Optimal stimulation settings selected for participants showed a 20% and 16% increase in RMR for the 2 participants. Overnight sleep energy expenditure measurements at these optimized settings on day 4 yielded a 10.4% and 4.8% increase over the baseline measurements for the 2 participants. CONCLUSIONS: These findings have demonstrated the efficacy of optimized DBS of the LH on increasing the RMR acutely and maintaining this increase during overnight sleep. These promising preliminary findings have laid the groundwork for the possible treatment of refractory obesity with DBS.

Deep brain stimulation for appetite disorders: a review.

The mechanisms of appetite disorders, such as refractory obesity and anorexia nervosa, have been vigorously studied over the last century, and these studies have shown that the central nervous system has significant involvement with, and responsibility for, the pathology associated with these diseases. Because deep brain stimulation has been shown to be a safe, efficacious, and adjustable treatment modality for a variety of other neurological disorders, it has also been studied as a possible treatment for appetite disorders. In studies of refractory obesity in animal models, the ventromedial hypothalamus, the lateral hypothalamus, and the nucleus accumbens have all demonstrated elements of success as deep brain stimulation targets. Multiple targets for deep brain stimulation have been proposed for anorexia nervosa, with research predominantly focusing on the subcallosal cingulate, the nucleus accumbens, and the stria terminalis and medial forebrain bundle. Human deep brain stimulation studies that focus specifically on refractory obesity and anorexia nervosa have been performed but with limited numbers of patients. In these studies, the target for refractory obesity has been the lateral hypothalamus, ventromedial hypothalamus, and nucleus accumbens, and the target for anorexia nervosa has been the subcallosal cingulate. These studies have shown promising findings, but further research is needed to elucidate the long-term efficacy of deep brain stimulation for the treatment of appetite disorders.

Craniotomy for subdural hematoma after deep brain stimulation surgery: Outcomes and satisfaction in a case series of two patients.

OBJECTIVE: To determine whether salvage of DBS hardware is beneficial for Parkinson's Disease (PD) patients by looking at follow-up patient's outcomes and satisfaction after their craniotomy operation. PATIENTS AND METHODS: This was a retrospective review of a prospective, single-center deep brain stimulation (DBS) database between 2002-2016 identifying patients with PD who developed subdural hematomas (SDH) due to trauma after their DBS surgery. Of the 636 DBS cases that were performed, 3 PD-DBS patients with significant traumatic SDH managed via craniotomy were identified. Out of these 3 patients, only 2 permitted outcome analysis. At follow-up, functional and neurologic status, UPDRS motor score, and overall satisfaction with DBS were assessed. RESULTS: Two patients were followed for a period of 10 and 9 months. At last follow-up, the DBS settings in patient 1 increased from a stimulation amplitude of 3.5 V to 4.5 V on the right and 3.3 V to 6.0 V on the left with an increase in the pulse width as well (70-80 ms and 80-140 ms on the right and left, respectively). Stimulation frequency remained 160 Hz on the right while increasing from 145 to 160 Hz on the left. Patient 2 experienced an increase in stimulation amplitude from 4.5 V to 4.8 V on the right while remaining the same on the left. Pulse width increased from 60 to 70 ms bilaterally as well as the frequency (160-185 Hz bilaterally). Despite craniotomy, both patients experienced substantial improvement in UPDRS motor score with DBS at last follow-up (53-25 and 20-17 for patient 1 and 2, respectively). At last follow-up, CT imaging provided evidence of complete SDH resolution with no persistent hemorrhage, mass effect or any obvious lead displacement. Patients expressed satisfaction with DBS and affirmed that they would undergo surgery again for the same outcome. CONCLUSION: Patients with PD are at higher risk for falls and may experience an increased risk of falling associated with SDH in the post-operative period after DBS implantation. Despite brain shift from SDH potentially distorting DBS leads, DBS implants still provided significant benefit in patients requiring craniotomy for SDH and patient satisfaction with DBS remained high. Salvage of DBS hardware is recommended since significant symptomatic improvement with DBS programming may still be attainable even in the setting of emergent craniotomy for SDH.

Thalamic Deep Brain Stimulation.

The use of deep brain stimulation (DBS) of the thalamus has been proven to be a safe and efficacious treatment for the management of many diseases. The most common indication for thalamic DBS remains essential tremor (ET), one of the most common movement disorders in the world. ET patients should be considered for surgical intervention when their tremor has demonstrated to be refractory to medication, a characteristic estimated to be present in roughly 50% of ET cases. Advantages of DBS over thalamotomy include its reversibility, the ability to adjust stimulation settings to optimize efficacy and minimize side effects, the ability to perform bilateral procedures safely, and an association with a lower risk of postoperative cognitive problems. The most common target of DBS for ET is the ventralis intermedius (VIM) of the thalamus, and the optimal electrode location corresponds to the anterior margin of the VIM. Other indications for thalamic DBS include non-ET tremor, obsessive-compulsive disorder, neuropathic pain, traumatic brain injury, Tourette's syndrome, and drug-resistant epilepsy among others.

Spinal Cord Stimulator Explantation: Motives for Removal of Surgically Placed Paddle Systems.

BACKGROUND: Despite requiring successful trials prior to implantation, spinal cord stimulation (SCS) systems for pain are often later removed. Removing surgically implanted hardware subjects patients to the risks and discomfort of a second surgery, threatens the cost-effectiveness of SCS, and limits the perceived durability of SCS technology for pain problems. OBJECTIVE: To investigate patterns of reasons given among patients who underwent SCS explant surgery (SCSES). METHODS: Retrospective review of SCSES cases over 17 years at Allegheny General Hospital, Pittsburgh, PA. RESULTS: 165 patients underwent SCSES between 1997 and 2014. The top 3 reasons for explantation were inadequate pain control (IPC; 73%), hardware discomfort (22%), and need for magnetic resonance imaging (MRI) (10%). Other less frequent reasons were infection (9%), painful dysesthesias (9%), electrical arcing (4%), resolution of inciting symptoms (4%), weakness (2%), pseudomeningocele (1%) and muscle spasms (1%). CONCLUSION: Inadequate pain control is the most common reason for SCSES. Advances in technology are needed to improve the quality and duration of pain control, as well as to design improvements to make the hardware more comfortable. A significant number of implants are removed due to need for MRI, a fact obviating the need for MRI-compatible systems. Patients considering SCS paddle lead placement should be counseled on the most common reasons for later explantation.