Safety and Efficacy of Adaptive Deep Brain Stimulation
ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNewronika
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.
Eligibility criteria
Qualifiers
Diagnosis of idiopathic PD;
Subject is bilaterally treated with DBS in the STN using a Medtronic Activa PC or Activa RC IPG (mono-channnel or dual channel);
DBS implant for at least 3 years and in need of battery replacement within 12 months after consent;
Patients must be able to understand and sign the informed consent document.
Disqualifiers
Patients with severe cognitive decline, as resulting from MoCA assessment (MoCA score < 10);
Patients with major psychiatric issues or any other condition that, based on the physician opinion, could interfere with the study conduct (e.g. severe depression, psychosis, etc.);
Patients with any medical conditions potentially interfering with DBS battery replacement surgery (e.g. severe hypertension, active cancer, intake of drugs interfering with the coagulation etc.);
Need to replace or reposition the leads during the IPG replacement procedure;
Trial design
Treatments tested in this trial
- AlphaDBS System
Treatment groups
15 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov