For patients with Parkinson’s disease, a post-operative model of deep brain stimulation (DBS) at home may be safe, effective, doable, and able to reduce the burden of travel for those who travel to receive DBS programs, according to those in JAMA . published neurology study results.
A team of researchers conducted an open-label randomized clinical trial (ClinicalTrials.gov Identifier: NCT02474459) at the University of Florida Health from 2017 to 2020 to evaluate the effectiveness of postoperative home treatment for DBS in patients with Parkinson’s disease. They tried to improve access to therapies and reduce the burden of travel.
Study researchers randomly (1: 1) assigned patients to either standard treatment or postoperative DBS home treatment for 6 months after surgery. Postoperative home nursing management was performed at home by a home nurse who had chosen the DBS setting. Home nursing staff had no previous DBS care experience and were supported by an iPad-based mobile application for the Parkinson’s DBS system.
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The primary endpoint was the frequency of patient travel to movement disorder clinics during the study period. Secondary endpoints included changes from baseline on the Unified Parkinson Disease Rating Scale Part 3 (UPDRS III).
A total of 44 patients were included in the study; 21 patients were assigned to standard care and 23 to DBS programming for home nursing. After 4 participants withdrew, 19 patients were added to the standard or care cohort and the 23 patients remained in the home health group.
All 23 patients (mean age 65.0 years; men 13) in the home health group underwent at least 1 postoperative DBS treatment visit; 18 patients completed the 6 month outcome visit. Nineteen patients (mean age 64.1 years; men 11) in the standard treatment group underwent at least one postoperative DBS treatment visit and 15 patients completed the 6-month outcome visit.
Patients in the home care arm had a slightly higher severity of Parkinson’s symptoms than patients in the standard treatment arm, as measured by the UPDRS III baseline without medication (40.5 and 33.5, respectively).
Patients in the home health care cohort traveled significantly less frequently to the movement disorder clinic for treatment than patients in the standard care cohort (mean visits 0.4 vs. 4.8; P <0.001). However, there was no significant difference between the total number of postoperative DBS treatment visits (face-to-face and phone visits) between the two groups (P = .06).
In addition, the results showed no significant differences between the groups in terms of changes from baseline and 6-month average results of the UPDRS III scores without medication (P = 0.27), the on-medication scores (P =, 90), the entire UPDRS-free medication (P = .08) or the 39-question Parkinson’s questionnaire (P = .97).
The limitations of this study included factors that influenced the primary endpoint, such as: B. Differences in visiting schedules for each group in the study and the high variability in DBS results.
“Further evidence has been gathered to demonstrate the effectiveness of the [mobile application for Parkinson disease] DBS technology to simplify the DBS programming process, ”the researchers noted. They concluded that “the disruption of the traditional expert care model should lead to the thoughtful development of new models of care that should significantly reduce the burden on patients and caregivers and improve access to DBS therapy”.
Disclosure: Several authors stated links to the pharmaceutical industry. For a full list of the details, see the original article.
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Duffley G, Lutz BJ, Szabo A, et al. Home health management of deep brain stimulation in Parkinson’s disease: a randomized clinical trial. JAMA Neurol. 2021; 78 (8): 972-981. doi: 10.1001 / jamaneurol.2021.1910
