RecruitingNot ApplicableNCT04681534

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

Sponsor

Newronika

Enrollment

15 participants

Start Date

Jan 26, 2021

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

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.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study tests an advanced form of deep brain stimulation (DBS) called "adaptive" DBS — a system that automatically adjusts electrical stimulation in real time based on brain signals — in people with Parkinson's disease who already have a DBS device and need their battery replaced. **You may be eligible if...** - You have been diagnosed with Parkinson's disease (idiopathic) - You already have a Medtronic Activa PC or RC DBS device implanted in both sides of your brain (STN) - Your DBS has been in place for at least 3 years - You need a battery replacement within the next 12 months - You can understand and sign the consent form **You may NOT be eligible if...** - You have severe cognitive decline (very low cognitive test score) - You have serious psychiatric conditions such as severe depression or psychosis - You have medical conditions that make battery replacement surgery unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAlphaDBS 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.