The approach was studied in the Nature Portfolio of journals’ npj Parkinson’s Disease. It outlines the medtech giant’s adaptive DBS algorithm for personalized therapy in Parkinson’s disease (ADAPT-PD). The global, multi-center, prospective, single-blind, randomized crossover study looks at the safety and effectiveness of chronic dual and single threshold aDBS models as compared to continuous DBS across all Parkinson’s patients eligible for DBS.
Medtronic said the study remains ongoing as the largest, longest assessment of aDBS in an at-home setting. To date, the company reports 68 participants with either subthalamic nucleus or globus pallidus internus DBS connected to a Percept PC neurostimulator.
Investigators monitored participants over four phases spanning more than a year. That included baseline examination, initial aDBS setup and adjustment, evaluation and long-term follow-up. Medtronic then offered all participants extended access to aDBS therapy after the follow-up period.
Preliminary data indicates a high brain signal presence both on and off medications, in both DBS target locations and patients of all PD phenotypes.
Medtronic recently filed for FDA approval of aDBS. It expects the results of its ADAPT-PD trial to support global regulatory submissions.
“For more than three decades, Medtronic’s investment in DBS research has led to significant improvements in therapeutic treatment for movement disorders and epilepsy,” said Amaza Reitmeier, VP and GM, Medtronic Brain Modulation. “This first-of-its-kind trial is a significant step forward in our journey to bring sensing-enabled DBS enhancements to patients.”The Medtronic Percept family of neurostimulators with exclusive BrainSense technology is the first and only DBS system with sensing, directionality, and advanced programming.
