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.
The study protocol is organized in two phases: the "short-term follow-up" and the "long-term follow-up". PD patients in need of IPG replacement or "de novo DBS" patients will be screened for enrollment eligibility. For the "short-term follow-up", 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). This part of the study will collect information on safety and potential efficacy endpoints as assessed by experienced neurologists. The "short term follow-up" phase will be considered complete when the endpoint assessment has been performed for all patients. Patients, who will not experience severe side effects and who will be deemed suitable by the neurologist, will be eligible to continue in the "long-term follow-up" phase (i.e. 1 month) in their "home" environment. The "AlphaDBS" System will deliver the stimulation in aDBS or cDBS mode, for two weeks in each mode.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15
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.
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
RECRUITINGIRCCS Istituto Neurologico Carlo Besta
Milan, Italy
COMPLETEDAzienda Ospedale Universitario di Padova - Università di Padova
Padua, Italy
Safety and tolerability of the "AlphaDBS" System, when used in cDBS and aDBS mode
Occurrence of device related adverse events
Time frame: 1 month
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 month
Dyskinesia
Evaluation of dyskinesia and their fluctuations through repeated clinical assessments using the Unified Dyskinesia Rating Scale - UDysRS
Time frame: 1 month
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 month
"Time on" with and without dyskinesia
Evaluation of "time on" with and without dyskinesia, assessed through Patient Diary
Time frame: 1 month
"Time off"
Evaluation of "time off", assessed through Patient Diary
Time frame: 1 month
Patient controller usability
Usability will be evaluated by means of a usability questionnaire
Time frame: 1 month
Usability of the system for the physician
Usability will be evaluated by means of a usability questionnaire
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
COMPLETEDAOU Città della Salute e della Scienza di Torino
Turin, Italy
COMPLETEDMaastricht Medical Center
Maastricht, Netherlands
WITHDRAWNCopernicus Podmiot Leczniczy
Gdansk, Poland
WITHDRAWNNarodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw, Poland
COMPLETEDTime frame: 1 month
Change in the TEED to the patient
Change in the Total Electrical Energy Delivered (TEED) to the patient
Time frame: 1 month