Contemporary Approaches to Preventing and Treating Infections of Novel Intrathecal Neurostimulation Devices.

INTRODUCTION: Contemporary approaches to surgical site infections have evolved significantly over the last several decades in response to the economic pressures of soaring health care costs and increasing patient expectations of safety. Neurosurgeons face multiple unique challenges when striving to avoid as well as manage surgical implant infections. The tissue compartment, organ system, or joint is characterized by biological factors and physical forces that may not be universally relevant. Such implants, once rare, are now routine. Although the prevention, diagnosis, and treatment of surgical site infections involving neural implants has advanced, guidelines are ever changing, and the incidence still exceeds acceptable levels. We assess the impact of these factors on a new class of implantable neuromodulation devices. METHODS: The available evidence along with practice patterns were examined and organized to establish relevant groupings for continuing evaluation and to propose justifiable recommendations for the treatment of infections that might arise in the case of intradural spinal cord stimulators. RESULTS: Few studies in the modern era have systematically evaluated preventive behaviors that were applied to intradural neural implants alone. We anticipate that future efforts will focus even more on the investigation of modifiable factors along a continuum from bacterially repellant implants to weight management. Early diagnosis could offer the best hope for device salvage but to date has been largely understudied. CONCLUSIONS: Historically, prevention is the cornerstone to infection mitigation. However, immediate diagnosis and hardware salvage have not received the attention deserved, and that approach may be especially important for intradural devices.

Brain Shift and Pneumocephalus Assessment During Frame-Based Deep Brain Stimulation Implantation With Intraoperative Magnetic Resonance Imaging.

BACKGROUND: Brain shift and pneumocephalus are major concerns regarding deep brain stimulation (DBS). OBJECTIVE: To report the extent of brain shift in deep structures and pneumocephalus in intraoperative magnetic resonance imaging (MRI). METHODS: Twenty patients underwent bilateral DBS implantation in an MRI suite. Volume of pneumocephalus, duration of procedure, and 6 anatomic landmarks (anterior commissure, posterior commissure, right fornix [RF], left fornix [LF], right putaminal point, and left putaminal point) were measured. RESULTS: Pneumocephalus varied from 0 to 32 mL (median = 0.6 mL). Duration of the procedure was on average 195.5 min (118-268 min) and was not correlated with the amount of pneumocephalus. There was a significant posterior displacement of the anterior commissure (mean = -1.1 mm, P < .001), RF (mean = -0.6 mm, P < .001), LF (mean = -0.7 mm, P < .001), right putaminal point (mean = -0.9 mm, P = .001), and left putaminal point (mean = -1.0 mm, P = .001), but not of the posterior commissure (mean = 0.0 mm, P = .85). Both RF (mean = -.7 mm, P < .001) and LF (mean = -0.5 mm, P < .001) were posteriorly displaced after a right-sided burr hole. There was a correlation between anatomic landmarks displacement and pneumocephalus after 2 burr holes (rho = 0.61, P = .007), but not after 1 burr hole (rho = 0.16, P = .60). CONCLUSION: Better understanding of how pneumocephalus displaces subcortical structures can significantly enhance our intraoperative decision making and overall targeting strategy.

Objective assessment of postural stability in Parkinson's disease using mobile technology.

BACKGROUND: A significant gap remains in the ability to effectively characterize postural instability in individuals with Parkinson's disease. Clinical evaluation of postural declines is largely subjective, whereas objective biomechanical approaches are expensive and time consuming, thus limiting clinical adoption. Recent advances in mobile devices present an opportunity to address the gap in the quantification of postural stability. The aim of this project was to determine whether kinematic data measured by hardware within a tablet device, a 3rd generation iPad, was of sufficient quantity and quality to characterize postural stability. METHODS: Seventeen patients and 17 age-matched controls completed six balance conditions under altered surface, stance, and vision. Simultaneous kinematic measurements were gathered from a three-dimensional motion capture system and tablet. RESULTS: The motion capture system and tablet provided similar measures of stability across groups. In particular, within the patient population, correlation between the two systems for peak-to-peak, normalized path length, root mean square, 95% volume, and total power values ranged from 0.66 to 1.00. Kinematic data from five balance conditions--double-leg stance with eyes open on a foam surface, double-leg stance with eyes closed on firm and foam surfaces, and tandem stance on firm and foam surfaces--were capable of discriminating patients from controls. CONCLUSIONS: The hardware within the tablet provides data of sufficient accuracy for the quantification of postural stability in patients with Parkinson's disease. The objectivity, portability, and ease of use of this device make it ideal for use in clinical environments lacking sophisticated biomechanical systems.

Barriers to investigator-initiated deep brain stimulation and device research.

The success of device-based research in the clinical neurosciences has overshadowed a critical and emerging problem in the biomedical research environment in the United States. Neuroprosthetic devices, such as deep brain stimulation (DBS), have been shown in humans to be promising technologies for scientific exploration of neural pathways and as powerful treatments. Large device companies have, over the past several decades, funded and developed major research programs. However, both the structure of clinical trial funding and the current regulation of device research threaten investigator-initiated efforts in neurologic disorders. The current atmosphere dissuades clinical investigators from pursuing formal and prospective research with novel devices or novel indications. We review our experience in conducting a federally funded, investigator-initiated, device-based clinical trial that utilized DBS for thalamic pain syndrome. We also explore barriers that clinical investigators face in conducting device-based clinical trials, particularly in early-stage studies or small disease populations. We discuss 5 specific areas for potential reform and integration: (1) alternative pathways for device approval; (2) eliminating right of reference requirements; (3) combining federal grant awards with regulatory approval; (4) consolidation of oversight for human subjects research; and (5) private insurance coverage for clinical trials. Careful reformulation of regulatory policy and funding mechanisms is critical for expanding investigator-initiated device research, which has great potential to benefit science, industry, and, most importantly, patients.