NCT04681534

Safety and Efficacy of Adaptive Deep Brain Stimulation

A Double-blind Crossover Study to Evaluate the Safety and Efficacy of Adaptive Deep Brain Stimulation Delivered Through AlphaDBS System in Patients With Parkinson's Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Newronika · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the safety and the potential efficacy of personalized Local Field Potential (LFP)-based adaptive Deep Brain Stimulation (aDBS), using the implantable pulse generator (IPG) of the "AlphaDBS" System, in Parkinson's Disease patients, chronically implanted in subthalamic nucleus (STN) for DBS.

Detailed description

The study protocol is organized in two phases: the "short-term follow-up" and the "long-term follow-up". PD patients in need of IPG replacement or "de novo DBS" patients will be screened for enrollment eligibility. For the "short-term follow-up", randomized patients will undergo 2 days of experimental sessions (i.e. one per each type of stimulation mode, cDBS and aDBS), in a well-controlled environment (i.e. during hospitalization). This part of the study will collect information on safety and potential efficacy endpoints as assessed by experienced neurologists. The "short term follow-up" phase will be considered complete when the endpoint assessment has been performed for all patients. Patients, who will not experience severe side effects and who will be deemed suitable by the neurologist, will be eligible to continue in the "long-term follow-up" phase (i.e. 1 month) in their "home" environment. The "AlphaDBS" System will deliver the stimulation in aDBS or cDBS mode, for two weeks in each mode.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	AlphaDBS System	AlphaDBS can be programmed with two different types of stimulation: conventional DBS and adaptive DBS, that automatically adjusts the energy delivered to patient using a biosignal, local field potential (LFP), in a close loop configuration.

Timeline

• Start date: 2021-01-26
• Primary completion: 2025-09-30
• Completion: 2025-12-30
• First posted: 2020-12-23
• Last updated: 2024-07-09

Locations

8 sites across 3 countries: Italy, Netherlands, Poland