Clinical trial NCT03422757: Safety and Efficacy of Adaptive DBS Vs Conventional DBS in Patients With Parkinson's Disease
Official title: A Double Blind, Crossover Study to Evaluate Safety and Efficacy of an Adaptive Deep Brain Stimulation Closed-loop Method Compared With Conventional Deep Brain Stimulation in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Newronika
Sponsor class: INDUSTRY
First posted: 2018-02-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Electrical Energy Delivered (TEED) to the patient
timeFrame: One day.
Secondary outcomes:
measure: Incidence of device related Adverse Events (safety and tolerability)
timeFrame: One day.
measure: Unified Parkinson's Disease Rating Scale (UPDRS) part III
timeFrame: One day.
measure: Unified Dyskinesia Rating Scale (UDysRS)
timeFrame: One day.
Other outcomes:
measure: Time "off"
timeFrame: One day.
measure: DBS Impairment Scale (DBS-IS)
timeFrame: One day.
measure: Local field potentials (LFP) during gait analysis
timeFrame: Four hours.
measure: Local field potentials (LFP) during speech analysis
timeFrame: Four hours.
measure: Local field potentials (LFP) during sleep analysis
timeFrame: One night.
Locations:
city: Milano
country: Italy
facility: Centro Parkinson e Disturbi del Movimento ASST G.Pini- CTO
city: Milano
country: Italy
facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
city: Pavia
country: Italy
facility: Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Study officials:
References: