Safety and Efficacy of Adaptive DBS Vs Conventional DBS in Patients With Parkinson's Disease

Newronika6 enrolled

Overview

This is an exploratory study to preliminary assess safety and efficacy of an adaptive Deep Brain Stimulation (DBS) closed-loop method in patients with PD. The study has been designed as a double blind randomized crossover trial that uses conventional DBS as a concurrent control in PD patients in need of Implantable Pulse Generator (IPG) replacement.

PD patients in need of IPG replacement will be screened to identify the ones eligible for enrollment. 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). During each experimental session experienced neurologists will collect information on safety and efficacy endpoints.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Parkinson Disease

Interventions

adaptive Deep Brain StimulationDEVICE

The investigational medical device ("AlphaDBSvext") is a portable, external, dual mode stimulator that can deliver adaptive DBS or conventional DBS for the treatment of PD. In the adaptive mode, the device records Local Field Potential activity from the implanted DBS electrode and simultaneously delivers stimulation through the same electrode based on the recorded signal.

conventional Deep Brain StimulationDEVICE

The same investigational medical device ("AlphaDBSvext") is used to deliver conventional DBS for the treatment of PD. In the conventional mode it delivers constant stimulation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of idiopathic PD; * DBS implant since at least 3 years and in need of battery replacement, defined by battery level \<25%; * Patients must be able to sign the informed consent document to participate in the clinical trial; * Patients with a suboptimal response to DBS treatment. Exclusion Criteria: * Patients with severe cognitive decline (MMSE \<25); * Patients with major psychiatric issues; * Patients with any medical condition potentially interfering with DBS battery replacement surgery; * Patients that cannot tolerate an interruption of DBS stimulation; * Patients taking only one levodopa dose per day; * Patients with no LFPs recorded from any contacts pair, during intraoperatory IPG replacement procedure; * Pregnant or breastfeeding women.

Locations (4)

Centro Parkinson e Disturbi del Movimento ASST G.Pini- CTO

Milan, Italy

Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

Milan, Italy

IRCCS Istituto Ortopedico Galeazzi

Milan, Italy

Fondazione Istituto Neurologico Nazionale Casimiro Mondino

Pavia, Italy

Outcomes

Primary Outcomes

Total Electrical Energy Delivered (TEED) to the patient

Difference in the TEED delivered to the patient in adaptive DBS versus conventional DBS mode.

Time frame: One day.

Secondary Outcomes

Incidence of device related Adverse Events (safety and tolerability)

Number of device relate Adverse Events or abnormal vital signs.

Time frame: One day.

Unified Parkinson's Disease Rating Scale (UPDRS) part III

Evaluation of motor symptoms through (UPDRS) part III, motor examination. The total score is computed from scores obtained on 18 items (0 best condition-4 worst condition), some considering multiple body parts.

Time frame: One day.

Unified Dyskinesia Rating Scale (UDysRS)

Evaluation of dyskinesia through repeated clinical assessments (using UDysRS).

Time frame: One day.

Data from ClinicalTrials.gov

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