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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
AlphaDBS System
DeviceAlphaDBS 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.
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: conventional DBSActive comparator 1 intervention
Group B: adaptive DBSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and tolerability of the "AlphaDBS" System, when used in cDBS and aDBS mode
Occurrence of device related adverse events
Time frame
1 monthSecondary outcomes
1
PD-related motor symptoms and their fluctuations
Evaluation of PD-related motor symptoms using the Unified Parkinson's Disease Rating Scale - UPDRS Part III.
Time frame
1 month2
Dyskinesia
Evaluation of dyskinesia and their fluctuations through repeated clinical assessments using the Unified Dyskinesia Rating Scale - UDysRS
Time frame
1 month3
Dyskinesia
Evaluation of the performance of a wearable accelerometer in detecting dyskinesia (compared to patient reported dyskinesia in the patient diary)
Time frame
up to 1 month4
"Time on" with and without dyskinesia
Evaluation of "time on" with and without dyskinesia, assessed through Patient Diary
Time frame
1 month Source ClinicalTrials.gov