Safety and Efficacy of Adaptive DBS Vs Conventional DBS in Patients With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title: A Double Blind, Crossover Study to Evaluate Safety and Efficacy of an Adaptive Deep Brain Stimulation Closed-loop Method Compared With Conventional Deep Brain Stimulation in Patients With Parkinson's Disease

Status Terminated

Clinical Trial Summary

This is an exploratory study to preliminary assess safety and efficacy of an adaptive Deep Brain Stimulation (DBS) closed-loop method in patients with PD.

The study has been designed as a double blind randomized crossover trial that uses conventional DBS as a concurrent control in PD patients in need of Implantable Pulse Generator (IPG) replacement.

Clinical Trial Description

PD patients in need of IPG replacement will be screened to identify the ones eligible for enrollment.

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). During each experimental session experienced neurologists will collect information on safety and efficacy endpoints. ;

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT03422757
• Study type: Interventional
• Source: Newronika
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2017
• Completion date: December 30, 2018