ADAPT-PD: Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (NCT04547712)
Summary
The pivotal trial supporting FDA approval of Medtronic's BrainSense Adaptive DBS — the prospective, single-blind, randomized crossover study of adaptive versus continuous DBS across 10 international centers in 68 Parkinson's patients. Adaptive DBS using LFP beta-band biomarkers provided superior motor control, reduced medication interaction side effects, and demonstrated durable benefit in both clinic and home settings. LFP biomarkers were identified in 92% of patients off medication, confirming near-universal applicability.
Why it matters
ADAPT-PD is the landmark trial that made the world's first FDA-approved adaptive DBS a reality in February 2025. With 40,000+ Medtronic DBS patients worldwide eligible for BrainSense Adaptive upgrade, this represents the largest simultaneous BCI clinical deployment in history — Medtronic's description of their commercial launch as the "largest-ever commercial launch of BCI technology" is accurate.
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