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

Newronika

Status

Terminated

Conditions

Parkinson Disease

Treatments

Device: adaptive Deep Brain Stimulation

Device: conventional Deep Brain Stimulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT03422757

NWK_aDBSext_01_2017

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.