Faculty Bibliography

OBJECTIVE:The aim was to examine research on the impact of spinal cord stimulation (SCS) on the reduction of preimplantation opioid dose and what preimplantation opioid dose is associated with a reduction or discontinuation of opioid use postimplantation. METHODS:Systematic review of literature from PubMed, Web of Science, and Ovid Medline search of "opioid" and "pain" and "spinal cord stimulator." Inclusion criteria included original research providing data on SCS preimplantation opioid dosing and 12 months postimplantation opioid dosing or that correlated specific preimplantation opioid dose or opioid dose cutoff with significantly increased likelihood of opioid use discontinuation at 12 months postimplantation. RESULTS:Systematic review of the literature yielded 17 studies providing data on pre-SCS and post-SCS implantation dose and 4 providing data on the preimplantation opioid dose that significantly increased likelihood of opioid use discontinuation at 12 months postimplantation. Data from included studies indicated that SCS is an effective tool in reducing opioid dose from preimplantation levels at 12 months postimplantation. Data preliminarily supports the assertion that initiation of SCS at a preimplantation opioid dose of ≤20 to ≤42.5 morphine milligram equivalents increases the likelihood of postimplantation elimination of opioid use. DISCUSSION/CONCLUSIONS:SCS is an effective treatment for many types of chronic pain and can reduce or eliminate chronic opioid use. Preimplantation opioid dose may impact discontinuation of opioid use postimplantation and the effectiveness of SCS in the relief of chronic pain. More research is needed to support and strengthen clinical recommendations for initiation of SCS use at lower daily opioid dose.

Cerebral palsy (CP) is a chronic congenital disorder as the result of abnormal brain development. Children suffering from CP often battle debilitating chronic spasticity, which has been the focus of recent academic literature. In this systematic review, the authors aim to update the current neuromodulation procedures for the treatment of spasticity associated with CP in all age groups. A systematic review following was conducted using PubMed from inception to 2020. After initial title and abstract screening, 489 articles were identified, and 48 studies met the inclusion criteria for this review. In total, a majority of the published articles of treatments for CP were reporting the use of selective dorsal rhizotomy (SDR) (54%), and the remainder were of intrathecal baclofen (ITB) pumps (29%) and extracorporeal shockwave therapy (ESWT) (17%). Each method was found to have improvement of spasticity at a rate that achieved statistical significance. ITB pump therapy is an all-encompassing method of treating spasticity in children from CP, as it allows for a less invasive treatment that can be titrated to individual patient needs; however, its disadvantages include its long-term maintenance requirements. SDR appears to be an effective method for permanent spasticity relief in young patients. ESWT is a more recent and innovative technique for offering relief of spasticity while being minimally invasiveness. Further studies are needed to establish optimal frequencies and sites of application for ESWT.

INTRODUCTION/UNASSIGNED:Deep brain stimulation (DBS) is a common surgical option for the treatment of medically refractory Parkinson's disease (PD). Manufacturer and User Facility Device Experience (MAUDE), a United States Food and Drug Administration (FDA)-compiled database of adverse event reports related to medical devices, is a public resource that can provide insight into the relative frequency of complications and patient complaints. MATERIALS AND METHODS/UNASSIGNED:We accessed the MAUDE database and queried for adverse reports for deep brain stimulators implanted for PD from January 1, 2009 to December 31, 2018. Complaints were classified into device malfunction, patient non-compliance, patient complaint, surgically managed complications (i.e. complications that are corrected via surgery), and death. Patient complaints were further stratified into ineffective stimulation, shock, overstimulation, battery-related problems, or pain at the pulse generator site. Surgically managed complications were classified as intraoperative complications, impedance, migration, erosion, infection, lead fracture, and lead disconnection. Each event could receive multiple classifications and subclassifications. RESULTS/UNASSIGNED:A total of 4,189 adverse event reports was obtained. These encompassed 2,805 patient complaints. Within this group, 797 (28%) events were classified as ineffective stimulation. There were 1,382 surgically managed complications, 104 (8%) of which were intraoperative complications, 757 (55%) documented impedance issues, 381 (28%) infections, and 413 (30%) lead-related issues. There were 53 documented deaths. CONCLUSIONS/UNASSIGNED:The MAUDE database has potential use as a real time monitor for elucidating the relative occurrence of complications associated with deep brain stimulation. It also allows for the analysis of device-related complications in specific patient populations. Although the database is useful in this endeavor, it requires improvements particularly in the standardization of reporting adverse events.

Introduction Deep brain stimulation (DBS) is a modality of treatment for medication refractory Parkinson's disease (PD) in patients with debilitating motor symptoms. While potentially life-changing for individuals with Parkinson's disease, characterization of adverse events for these DBS devices have not yet been systematically organized. Therefore, the goal of this study was to characterize reported complications of DBS devices reported to the Food & Drug Administration over the last 10 years. Methods The Manufacturer and User Facility Device Experience (MAUDE) database was utilized to retrieve entries reported under "Stimulator, Electrical, Implanted, For Parkinsonian Symptoms" between July 31, 2010 and August 1, 2020. After removing duplicate entries, each unique adverse event reported was sorted into complication categories based on the entries' provided narrative description. A final tabulation of complications was generated. Results The search query revealed 221 unique adverse events. The most common DBS devices were the Vercise Gevia, Vercise Cartesia and Vercise PC produced by Boston Scientific (Brian Walker, Boston Scientific, Marlborough, MA, USA). The most commonly reported complications were infection (16.2%) follow by lead migrations (8.6%). Other common causes of complications were circuit-related impedance (6.5%), cerebral bleeds (6.3%), device failure (6.3%) and device-related trauma (4.5%). Over a third (40%) of all devices reported with adverse events required returning to the operating room for explant or revision. Conclusion The most common complications of DBS systems are infections followed by lead migrations. Further research is needed to minimize infection rates associated with DBS systems and to reduce intrinsic device malfunctions for patients in the future.

Deep brain stimulation (DBS) is a neurosurgical procedure that allows targeted circuit-based neuromodulation. DBS is a standard of care in Parkinson disease, essential tremor and dystonia, and is also under active investigation for other conditions linked to pathological circuitry, including major depressive disorder and Alzheimer disease. Modern DBS systems, borrowed from the cardiac field, consist of an intracranial electrode, an extension wire and a pulse generator, and have evolved slowly over the past two decades. Advances in engineering and imaging along with an improved understanding of brain disorders are poised to reshape how DBS is viewed and delivered to patients. Breakthroughs in electrode and battery designs, stimulation paradigms, closed-loop and on-demand stimulation, and sensing technologies are expected to enhance the efficacy and tolerability of DBS. In this Review, we provide a comprehensive overview of the technical development of DBS, from its origins to its future. Understanding the evolution of DBS technology helps put the currently available systems in perspective and allows us to predict the next major technological advances and hurdles in the field.

OBJECTIVE:To conduct a systematic review of the available literature for primary research articles identifying potential gene mutations, polymorphisms and other molecular regulatory mechanisms related to trigeminal neuralgia in order to identify the genetic and molecular models of primary trigeminal neuralgia currently being investigated. METHODS:PubMed and Web of Science were systematically searched to identify primary research articles discussing genetic predictors of trigeminal neuralgia and neuropathic pain that were published prior to July 2020. This review was conducted according to PRISMA guidelines. RESULTS:Out of the 333 articles originally identified, a total of 14 papers were selected for study inclusion. These articles included 5 human studies, 6 mouse studies and 3 rat studies. Four articles investigated sodium channels, 1 investigated a sodium channel and nerve growth factor receptor, 2 investigated potassium channels, 1 investigated calcium channels, 1 investigated the downstream regulatory element antagonist modulator protein, 1 investigated the dynorphin-kappa opioid receptor system, 1 investigated TRPA1, 1 investigated the Nrg1/ErbB3/ErbB2 signaling complex, 1 investigated a serotonin transporter and 1 investigated potassium channels, sodium channels, calcium channels, chloride channels, TRP channels and gap junctions. CONCLUSION/CONCLUSIONS:Researchers have identified multiple genetic and molecular targets involved with potential pathophysiologies that have a relationship to the creation of trigeminal neuralgia. At this time, there does not seem to be clear causal frontrunner, demonstrating the possibility that genetic predisposition to trigeminal neuralgia may involve multiple genes and/or downstream products, such as ion channels.

BACKGROUND:Spinal cord stimulation (SCS) is a neuromodulatory technique used to relieve chronic pain. Previous instances of malicious remote control of implantable medical devices, including insulin delivery pumps and implantable cardiac defibrillators, have been documented. Though no cases of neuromodulatory hacking have been recorded outside of the academic setting, an understanding of SCS technology and the possible consequences of manipulation is important in promoting safety. METHODS:We review the components and implantation protocol of a SCS system, the functionality and technological specifications for SCS systems in the global market based on their device manuals, and patient- and clinician-specific adjustable factors. Furthermore, we assess documented instances of implantable medical device hacking and speculate on the potential harms of targeting SCS systems. RESULTS:SCS systems from Abbott Laboratories, Boston Scientific, Medtronic, and Nevro have unique functionality and technological specifications. Six parameters in device control can potentially be targeted and elicit various harms, including loss of therapeutic effect, accelerated battery drainage, paresthesia in unintended locations, muscle weakness or dysfunction, tissue burn, and electrical shock. CONCLUSIONS:Based on the history of implantable medical device hacking, SCS systems may also be susceptible to manipulation. As the prevalence of SCS use increases and SCS systems continuously evolve in the direction of wireless control and compatibility with mobile devices, appropriate measures should be taken by manufacturers and governmental agencies to ensure safety.

While CDD directly to the CSF can provide a constant delivery of the dopaminergic drug resulting in a more stable treatment effect without the limitations of traditional oral therapy without peripheral effects, it is still young and longitudinal data is lacking. These experimental therapies show promise and further investigation into their efficacy and safety could extend the frontiers for management of PD.