Publications by authors named "Katherine Stromberg"
Background: Long-term levodopa use is frequently associated with fluctuations in motor response and can have a serious adverse effect on the quality of life (QoL) of patients with Parkinson's disease (PD). Deep brain stimulation (DBS) is effective in improving symptoms of diminished levodopa responsiveness. QoL improvements with DBS have been shown in several randomized control trials, mostly in Europe and the United States; however, there is a need for evidence from regions around the world.
View Article and Find Full Text PDFObjectives: To assist in assessment of therapy risks and benefits of targeted drug delivery (TDD) for chronic nonmalignant pain using registry data on product performance, adverse events, and elective device replacement.
Materials And Methods: The Product Surveillance Registry (PSR) (NCT01524276) is an ongoing prospective, long-term, multicenter registry enrolling consented patients implanted with an intrathecal drug delivery system. Patients are followed prospectively with participating investigators providing pump and catheter performance data for events related to the device, procedure, and therapy.
Background And Objectives: Multiple variables play a role in spinal cord stimulation (SCS) treatment outcomes, including patient anatomy, pain pattern, lead location, stimulation parameters, and so on. A wide range of stimulation parameters are considered safe and on-label, and as a result a growing number of new frequencies and frequency-combinations are being incorporated into standard practice. A standardized approach to therapy delivery may provide more consistent outcomes for more patients.
View Article and Find Full Text PDFObjective: To assist in the assessment of intrathecal baclofen (ITB) therapy risks and benefits by providing surgical intervention rate, safety, and elective device replacement rate data.
Materials And Methods: An ongoing prospective, long-term, multicenter Product Surveillance Registry (PSR) (NCT01524276) enrolled consented patients implanted with the SynchroMed II infusion system. Pump and catheter performance data were collected, with patients followed prospectively for events related to the device, procedure, and therapy.
Background: The safety and efficacy of intrathecal drug delivery systems (IDDSs) for the treatment of cancer-related pain have been demonstrated in randomized controlled clinical trials (RCTs). Despite positive evidence for this therapy, IDDS remains underutilized to treat cancer pain. Real-world registry data augment existing safety and effectiveness data and are presented here to broaden awareness of this therapeutic option, needed for adequate cancer-related pain treatment, and as a viable tool addressing concerns with systemic opioid use.
View Article and Find Full Text PDFArticle Synopsis
- The Implantable Systems Performance Registry (ISPR) was established to monitor the effectiveness and reliability of Medtronic's Spinal Cord Stimulation (SCS) and intrathecal drug infusion systems in the U.S.
- The study analyzed data from 2,605 patients over a nearly 10-year period, focusing on demographics, device durability, and lead-related performance issues.
- Findings reveal a high device survival rate (over 97%) for neurostimulators and over 95% for extension events, with the ISPR serving as a resource for improving product safety and development.
Objective: The catheter status of patients who presented with loss of intrathecal baclofen (ITB) therapy effectiveness was investigated using measurements of cerebrospinal fluid (CSF) pressure transmitted through the catheter fluid path to the pump. The aim of the study was to estimate the appropriate threshold separating catheter complications from "normal" catheter function, and to compare catheter status based on CSF pressure with the clinical diagnosis.
Methods: This was a prospective, masked nonsignificant risk, research study.
Background: Limited data have been published regarding the long-term results of sacral nerve stimulation, or sacral neuromodulation, for severe fecal incontinence.
Objectives: The aim was to assess the outcome of sacral nerve stimulation with the use of precise tools and data collection, focusing on the long-term durability of the therapy. Five-year data were analyzed.
Objective: The aim of the present analysis was to report on the relationship between long-term improvement in quality of life (QOL) and fecal incontinence (FI) severity and long-term reduction in FI episodes after sacral nerve stimulation (SNS) or sacral neuromodulation.
Methods: Patients who met inclusion/exclusion criteria, and initially had more than 2 FI episodes per week, were offered SNS therapy. Patients with 50% or higher reduction in FI during a 2-week test period were implanted with a neurostimulator (InterStim; Medtronic, Minneapolis, Minn).