Safety and Efficacy of Adaptive Deep Brain Stimulation

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Device: AlphaDBS System

• Registration Number: NCT04681534
• Lead Sponsor: Newronika

Brief 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.

Detailed Description

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 Timeline

• Study First Submitted: 2020-11-20
• Study First Submitted QC: 2020-12-19
• Study First Posted: 2020-12-23
• Study Start: 2021-01-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
adaptive DBS	AlphaDBS System	-
conventional DBS	AlphaDBS System	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of the "AlphaDBS" System, when used in cDBS and aDBS mode	1 month	Occurrence of device related adverse events

Secondary Outcome Measures

Name	Time	Method
Change in the TEED to the patient	1 month	Change in the Total Electrical Energy Delivered (TEED) to the patient
"Time on" with and without dyskinesia	1 month	Evaluation of "time on" with and without dyskinesia, assessed through Patient Diary
PD-related motor symptoms and their fluctuations	1 month	Evaluation of PD-related motor symptoms using the Unified Parkinson's Disease Rating Scale - UPDRS Part III.
Dyskinesia	up to 1 month	Evaluation of the performance of a wearable accelerometer in detecting dyskinesia (compared to patient reported dyskinesia in the patient diary)
Patient controller usability	1 month	Usability will be evaluated by means of a usability questionnaire
"Time off"	1 month	Evaluation of "time off", assessed through Patient Diary
Usability of the system for the physician	1 month	Usability will be evaluated by means of a usability questionnaire

Trial Locations

Locations (8)

Maastricht Medical Center; 🇳🇱 Maastricht, Netherlands

IRCCS Istituto Neurologico Carlo Besta; 🇮🇹 Milan, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy

Azienda Ospedale Universitario di Padova - Università di Padova; 🇮🇹 Padova, Italy

AOU Città della Salute e della Scienza di Torino; 🇮🇹 Turin, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy

Copernicus Podmiot Leczniczy; 🇵🇱 Gdańsk, Poland

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy; 🇵🇱 Warsaw, Poland