Objective: This multicenter double-blind crossover study has been designed to evaluate the safety and efficacy of adaptive Deep Brain Stimulation delivered through an innovative IPG in patients with Parkinson’s Disease, using conventional DBS (cDBS) as control.

Background: After several years of initial use with external systems and proof-of-concept studies adaptive deep brain stimulation (aDBS) is getting ready to enter the clinical practice of Parkinson’s Disease (PD) treatment with the introduction of fully aDBS capable implantable pulse generators (IPGs). Here we report the results of the first patient with Parkinson’s Disease implanted with a new generation DBS IPG capable of continuous sensing of neuronal activity from the subthalamic nucleus (STN) and contemporaneous delivery of DBS with parameters automatically adapted to match the patient’s clinical state as estimated from the analysis of STN activity, already tested as external device.

Method: The study involves 7 Investigational sites, in Italy, Poland, and the Netherlands. After eligibility screening, PD patients already implanted with DBS systems and in need of battery replacement are randomized to enter a two-phases protocol, including a “short-term follow-up” and a “long-term follow-up”. During the “short-term follow-up”, randomized patients undergo 2 days of experimental sessions (i.e. one per each type of stimulation mode, cDBS, and aDBS, order randomized), in a well-controlled environment (during hospitalization). Then, patients not experiencing severe side effects can continue to the “long-term follow-up” phase (1 month) in their home environment, with stimulation delivered in aDBS or cDBS mode, for two weeks in each mode.

Results: The study was approved by all Ministries of Health because it uses an investigational device and by all relevant Ethical Committees. Data collection started in January 2021. Data from the first patients implanted showed that AlphaDBS recordings were completely stimulation artefact-free. The aDBS feature worked as expected, following the beta band activity in a linear fashion.

Conclusion: This first report of a patient series implanted with a fully-capable aDBS implantable device opens the way of aDBS use, providing an innovative therapy to all PD patients undergoing DBS.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-new-fully-implantable-adaptive-deep-brain-stimulation-system-tested-for-the-first-time-in-patients-with-parkinsons-disease/