The Department of Neurology and Neurological Sciences at Stanford University School of Medicine, in collaboration with multiple academic medical centers across the US, Canada, Europe, Jordan, and Medtronic, has demonstrated that long-term, at-home adaptive deep brain stimulation (DBS) is safe, effective, and tolerable in people with Parkinson’s disease who were previously stable on continuous DBS.
Why Adaptive DBS Matters
Traditional Parkinson’s disease care relies on continuous DBS combined with medication. However, this approach cannot adapt to fluctuations in symptoms or medication cycles. Earlier single-center studies showed short-term feasibility of adaptive DBS in clinical settings. The current study extends this knowledge by testing whether adaptive DBS is effective and safe for long-term use at home.
Study Design and Participants
The clinical trial, “Long-Term Personalized Adaptive Deep Brain Stimulation in Parkinson Disease: A Nonrandomized Clinical Trial” published in JAMA Neurology, enrolled 68 participants with moderate to advanced Parkinson’s disease. All participants had bilateral leads implanted in either the subthalamic nucleus or the globus pallidus internus and met sensing criteria in the 8–30 Hz α-β band.
Researchers designed an open-label study with a randomized, single-blind crossover between two adaptive modes for participants who tolerated both. The single-threshold and dual-threshold algorithms adjusted stimulation levels based on local field potential activity in the α-β frequency range. Each tolerated mode was tested for 30 days at home, with medications kept stable.
Primary and Secondary Outcomes
As reported by medicalxpress, the primary outcome required at least 50% of participants to maintain “on-time without troublesome dyskinesias” compared with continuous DBS. To address analytic challenges, researchers later revised this to a time-based threshold, allowing no more than a two-hour daily loss of on-time.
The secondary outcome measured total electrical energy delivered. Researchers also monitored adverse events to assess safety.
Key Findings
Results showed that adaptive DBS met both prespecified and post hoc performance goals:
- Under the post hoc threshold (≤2 hours/day loss of on-time), 91% of participants on dual-threshold and 79% on single-threshold achieved comparable results to continuous DBS.
- Single-threshold stimulation reduced energy delivery by an average of 15% compared with continuous DBS (P = .01), with a similar trend observed in the dual-threshold mode.
- Exploratory analyses suggested that dual-threshold stimulation may further increase on-time and reduce off-time compared with continuous DBS.
Safety Profile
The safety analysis revealed strong tolerability:
- All but one stimulation-related adverse event resolved during setup and adjustment.
- No serious device-related adverse events occurred during long-term follow-up.
Conclusion
Researchers concluded that chronic, at-home adaptive DBS guided by personalized neural physiomarkers is feasible and clinically viable compared with standard continuous stimulation. Notably, it reduced energy consumption in at least one mode and maintained a favorable safety profile.