Safety and Efficacy of Adaptive Deep Brain Stimulation

Recruiting N/A Interventional Study
Parkinson Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
Newronika · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
IPG Replacement Patients: Inclusion Criteria 1. Diagnosis of idiopathic PD; 2. Subject is bilaterally treated with DBS in the STN using a Medtronic Activa PC or Activa RC IPG (mono-channnel or dual channel); 3. DBS implant for at least 3 years and in need of battery replacement within 12 months af…
Contacts

Costanza Conti, PhD

+39 02 84 109 381

costanza.conti@newronika.com

CONTACT