NCT05262348

An Open-label Clinical Trial to Compare the Safety and Effectiveness of Adaptive Versus Conventional Deep Brain Stimulation

A Prospective, Multi-center, Open-label, Pivotal Clinical Trial to Compare the Safety and Effectiveness of Adaptive Versus Conventional Stimulation in Advanced Levodopa-Responsive Parkinson's Disease Treated With Bilateral Deep Brain Stimulation

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Newronika · Industry
• Sex: All
• Age: 55 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The clinical trial aims to evaluate the safety and effectiveness of bilateral subthalamic nucleus (STN) and Globus Pallidus internus (GPi) deep brain stimulation (DBS) with the AlphaDBS IPG System when programmed in adaptive versus conventional stimulating modes. It includes an initial open-label, crossover phase and a long term follow-up phase, during which the patient is free to switch between stimulating modes.

Detailed description

This is an international multi-center (North America and Europe) clinical trial to evaluate the safety and effectiveness of bilateral STN and GPi DBS with the AlphaDBS IPG System when programmed in adaptive (aDBS) versus conventional (cDBS) stimulating modes, in patients with advanced levodopa-responsive Parkinson's disease (PD). The protocol is comprised of: Phase 1: Initial Treatment Period: Cross-Over Design * Phase 1a: All patients will start the study in cDBS mode. After a 1-month post-surgical stabilization, the AlphaDBS IPG System will be turned ON in cDBS mode. Participants will complete a 1-month period of programming optimization (to fine tune medical therapies and stimulation parameters) followed by a 3-month period of cDBS. * Phase 1b: At the end of the 3-month follow up in cDBS, participants will be switched to the aDBS mode. Participants will then complete a 1-month period of optimization (to fine tune medical therapies and stimulation parameters) followed by a 3-month period of aDBS. Phase 2: Long-term follow-up: Naturalistic Follow-up Design Patients completing Phase 1 are eligible to enter long-term follow-up for up to an additional 28 months. During this time, patients are free to change the DBS mode as preferred (with a maximum switches set by the physician). Visits at 6-month follow-ups will collect safety and efficacy data.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	adaptive DBS delivered through AlphaDBS IPG System	The AlphaDBS IPG System delivers both conventional DBS and adaptive DBS. Adaptive DBS is a programming mode that provides stimulation in a closed-loop adaptive "real-time" fashion, using a biosignal recorded from the same macro-electrodes routinely implanted for DBS as an input variable.
DEVICE	conventional DBS delivered through AlphaDBS IPG System	The AlphaDBS IPG System delivers both conventional DBS and adaptive DBS. Conventional DBS is programmed by DBS specialists.

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-08-30
• Completion: 2026-12-31
• First posted: 2022-03-02
• Last updated: 2024-08-12