Safety, Feasibility of Postoperative Home Health Deep Brain Stimulation for PD

For patients with Parkinson disease, a postoperative home health-based care deep brain stimulation (DBS) model may be safe, effective, feasible, and capable of reducing travel burden for those who travel to receive DBS programming, according to study results published in JAMA Neurology.

A team of investigators conducted an open-label randomized clinical trial (ClinicalTrials.gov Identifier: NCT02474459) at University of Florida Health from 2017 to 2020 to assess the efficacy of home health DBS postoperative management in patients with Parkinson disease. They sought to improve therapy access and reduce travel burden.

Study researchers randomly assigned patients (1:1) to either receive standard of care or home health postoperative DBS management for 6 months following surgery. The home health postoperative management was conducted at home by a home health nurse who chose the DBS setting. Home health nurses did not have any previous experience providing DBS care and were aided by an iPad-based mobile application for the Parkinson disease DBS system.

The primary outcome was the travel frequency to movement disorders clinics among patients during the study period. Secondary outcomes included changes on the Unified Parkinson Disease Rating Scale part 3 (UPDRS III) from baseline.

A total of 44 patients were enrolled in the investigation; 21 patients were assigned to standard of care and 23 were assigned to home health DBS programming. After 4 participants withdrew, 19 patients were included in 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 DBS postoperative management visit; 18 patients completed the 6-month outcomes visit. Nineteen patients (mean age, 64.1 years; men, 11) in the standard of care group underwent at least 1 DBS postoperative management visit and 15 patients completed the 6-month outcomes visit.

Patients in the home health arm had slightly higher Parkinson disease symptoms severity than patients in the standard of care arm, as measured by the baseline UPDRS III off-medication scores (40.5 vs 33.5, respectively).

Patients in the home health cohort traveled significantly less to the movement disorder clinic for care than patients in the standard of care cohort (mean visits, 0.4 vs 4.8, respectively; P <.001). However, there was no significant difference between the total number of DBS postoperative management visits (in-person and telephone visits) between the 2 groups (P =.06).

Additionally, findings indicated no significant differences between the groups for changes between baseline and 6-month mean outcomes of UPDRS III off-medication scores (P =.27), on-medication scores (P =.90), total UPDRS off-medication scores (P =.08), or the 39-question Parkinson’s Disease Questionnaire (P =.97).

Limitations of this study included factors that influenced the primary outcome, such as differences in the visit schedules given to each group in the study, and the high variability of DBS outcomes.

“Further evidence was collected to demonstrate the capability of the [mobile application for Parkinson disease] DBS technology to simplify the DBS programming process,” the study researchers noted. They concluded that “disruption of the traditional expert-based care model should lead to the thoughtful development of new care models designed to substantially reduce the burden on patients and caregivers and improve access to DBS therapy.”

Disclosure: Multiple authors declared affiliations with the pharmaceutical industry. Please refer to the original article for a full list of disclosures.

Reference

Duffley G, Lutz BJ, Szabo A, et al. Home health management of Parkinson disease deep brain stimulation: a randomized clinical trial. JAMA Neurol. 2021;78(8):972-981. doi:10.1001/jamaneurol.2021.1910