Patients who underwent deep brain stimulation procedures that were managed postoperatively in the home reported significantly fewer clinic visits with similar MDS-UPDRS scores to standard of care.
Open-label, randomized clinical trial data presented at the International Parkinson and Movement Disorders Society (MDS) Virtual Congress 2021, September 17-22, suggest that conducting home health management via deep brain stimulation postoperatively is safe and feasible for patients with Parkinson disease (PD).1
All told, the primary outcome—defined as the number of times each patient traveled to the movement disorders clinic during the study period—revealed that those randomized to home health management (n = 23; 4.8 [±0.4]) had fewer clinic visits than those who were in the standard of care arm (SOC, n = 21; 0.4 [±0.8]), a significant between-group difference (P <.0001).
“The travel required to receive [DBS] programming is a substantial burden on patients, and limits those who can access DBS therapy,” the authors, including Adolfo Ramirez-Zamora, MD, associate professor, program director, and chief, Division of Movement Disorders, University of Florida, wrote. They added that the goal of this trial was to “Evaluate the efficacy of home health DBS postoperative management” with the aim of ultimately reducing that burden and improving access to DBS care for the population with PD.
"We wanted to confirm that the study would be safe and that no additional clinic visits would be needed," Ramirez-Zamora told NeurologyLive. "Patients tolerated changes well and efficacy was comparable. Programming at home allowed for flexible programming using a non-conventional approach. It suggests that individualized, patient-specific, anatomical tools could be very helpful for DBS management. Additional research is needed in the broader PD population, including larger implementation at other centers. Identifying the best candidates (or not) for this programming procedure would be critical going forward along with larger follow up."
Ramirez-Zamora et al. observed no significant differences between the groups in the secondary outcomes measuring the efficacy of DBS, which included changes from baseline in the Unified Parkinson’s Disease Rating Scale part III (UPDRS III). No adverse events (AEs) were deemed related to the study procedure or devices.
In total, 44 patients were enrolled in the study. The final analyses included 19 patients in the SOC group and 23 patients in the home health who underwent a minimum of 1 postoperative management visit. The home health postoperative management included 2 in-person visits and 3 phone-based visits, conducted by a home health nurse who chose DBS settings with the aid of the iPad-based Mobile Application for PD DBS (MAP DBS) system. Prior to the study period, the home health nurse had no experience providing DBS care.
The study was conducted at University of Florida Health from 2017 to 2020, with consenting participants who were receiving DBS as part of SOC treatment for Parkinson disease were 1:1 randomized to receive either SOC or home health postoperative DBS management for the first 6 months after surgery. Primary caregivers, usually the spouse, were also enrolled to assess caregiver strain.
Although DBS has established itself as an effective approach in PD care, because of the need for surgical procedures to utilize it, many patients who are candidates are hesitant to undergo such operations. Data has shown that surgical care for PD is safe and effective, and many physicians believe it should no longer be treated as a consideration of last resort.
Earlier this year, Atom Sarkar, MD, PhD, professor of Neurosurgery, Drexel University College of Medicine, and professor of Pharmacology & Physiology, Drexel Neurosciences Institute; director, Stereotactic, Functional, and Epilepsy Surgery, and codirector, Philadelphia Voice Tremor Center, Global Neurosciences Institute, authored the cover story for NeurologyLive’s April 2021 issue, detailing why DBS should be a treatment option discussed early in the disease course with the patient and their family. “Innovations in neurobiology, science, technology, engineering, and public awareness will shape the future of DBS in ways that we might not even be able to imagine right now. All the work will have been for naught, though, if DBS continues to enjoy simply a niche status,” Sarkar wrote.
One of those innovations has been the development of adaptive DBS, an investigational feature of the Percept PC device that uses proprietary BrainSense technology to continuously capture and record brain signals while delivering therapy. In January, Medtronic announced ADAPT-PD trial (NCT04547712) to evaluate the safety and efficacy of adaptive deep brain stimulation (aDBS) in patients with PD. The randomized study is being conducted at 12 study sites at movement disorders research centers in the US, Europe, and Canada, and plans to enroll 36 subjects for a 15-month evaluation. The primary end point will be the comparison of aDBS to standard continuous DBS for hours of ON time without troublesome dyskinesias, efficacy, and AEs by patient reports.2
Ramirez-Zamora recently appeared on the NeurologyLive Mind Moments podcast to discuss several topics in the field of Parkinson disease. Specifically, he detailed the current state of care for patients with advanced Parkinson disease, the ongoing clinical development of therapies and approaches to the management of the disease, the remaining challenges to address in the clinic, the areas of need around education and awareness, and where the field is headed in the future. Listen below to hear his expert insight on Parkinson disease.
For more coverage of MDS 2021, click here.