Remote vs In-Person Follow-up Programming After Subthalamic DBS for Parkinson Disease: A Multicentre Randomized Noninferiority Trial

Technical Summary: Remote vs. In-Person Follow-up Programming After Subthalamic DBS for Parkinson Disease

Problem Statement
Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a standard therapy for advanced Parkinson disease (PD) with motor fluctuations. However, optimizing clinical outcomes requires iterative postoperative programming, which traditionally necessitates frequent in-person visits to specialized centers. This requirement creates significant barriers for patients with mobility constraints or those living at a distance. While telemedicine-based remote programming has emerged as a potential strategy to decentralize care, existing evidence is limited by a lack of randomization, heterogeneous outcome assessments, and reliance on retrospective or nonrandomized studies. Consequently, prospective randomized evidence comparing remote follow-up programming against standard in-person care following standardized inpatient initiation remains absent.

Methodology
The study, titled REMOTE, was a prospective, randomized, open-label, multicenter noninferiority trial conducted across six German centers.

• Participants: 52 adults with idiopathic PD who had recently undergone bilateral STN-DBS implantation. All participants received initial in-person postoperative programming before randomization.
• Intervention: Participants were randomized 1:1 to either:
  1. Standard of Care (SoC): Conventional in-person follow-up programming during the first 90 days post-surgery.
  2. Remote Programming: Exclusive follow-up via a secure telemedicine platform (Abbott NeuroSphere™ Virtual Clinic) allowing video consultations and remote parameter adjustment.
• Primary Outcome: The Movement Disorder Society–Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score at 90 days in the medication-on/stimulation-on state.
• Statistical Design: The trial was powered to test noninferiority with a prespecified margin of 5 points on the MDS-UPDRS Part III. The primary analysis followed a per-protocol (PP) estimand, with a supportive intention-to-treat (ITT) analysis. Nonparametric methods (Mann–Whitney U test) and bootstrap resampling were used to estimate between-group differences.
• Secondary Outcomes: Included MDS-UPDRS Parts I, II, and IV; quality of life (PDQ-39-SI); depression (BDI-II); cognition (MoCA); Hoehn and Yahr scale; levodopa equivalent daily dose (LEDD); and safety/adverse events.

Key Results

• Primary Endpoint: The study met the prespecified noninferiority criterion. The between-group median difference in the primary endpoint (MDS-UPDRS Part III at 90 days) was −2.5 points (95% CI, −9.0 to 2.0), which falls within the noninferiority margin of 5 points. Both groups showed significant motor improvement from baseline.
• Secondary Clinical Outcomes: Secondary motor and nonmotor outcomes were broadly comparable between groups.
  • Total MDS-UPDRS scores decreased significantly in both groups.
  • MDS-UPDRS Parts II and IV improved similarly.
  • LEDD Reduction: The SoC group showed a numerically larger reduction in LEDD (median −525 mg) compared to the remote group (median −244 mg), a difference that was statistically significant (P = .015).
  • Cognition: The MoCA score showed a slight decline in the SoC group and a slight improvement in the remote group, resulting in a statistically significant between-group difference in change (P = .03).
• Safety: Serious adverse events (SAEs) occurred at similar frequencies (11.5% in SoC vs. 15.3% in remote). No deaths occurred. Specific events included intracerebral hemorrhage, lead edema, falls, surgical site infections, and one suicide attempt in the SoC group. No clear safety signal favored either strategy.
• Protocol Deviations: In the remote group, four participants were excluded from the per-protocol analysis due to protocol-defined intercurrent events, including two who required crossover to in-person care due to insufficient symptom control (specifically gait instability) that could not be resolved via remote adjustments alone.

Significance and Claims
The paper claims that remote follow-up programming after standardized inpatient initiation is feasible, safe, and clinically noninferior to conventional in-person care for motor outcomes during the first three months post-STN-DBS surgery.

Key claims regarding the study's contribution include:

1. Evidence Gap Filled: This is the first prospective randomized trial directly comparing remote DBS follow-up programming against standard in-person care after a standardized inpatient initiation phase.
2. Hybrid Care Validation: The results support the integration of remote programming as a practical component of hybrid postoperative care pathways, particularly for patients with limited access to specialized centers.
3. Limitations of Remote Care: The study explicitly notes that remote programming is not universally interchangeable with in-clinic management. The necessity of crossover for some patients highlights that patient selection and symptom profile (e.g., complex gait instability) are critical determinants for remote suitability.
4. Safety Profile: The comparable safety profile observed in this randomized setting supports the short-term safety of remote programming when delivered within established DBS programs.

The authors conclude that while remote programming achieves motor outcomes noninferior to in-person care in the early postoperative period, longer-term studies are required to define durability, cost-effectiveness, and the specific scenarios where selective in-person troubleshooting remains necessary.