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

Not Applicable

Terminated

• Conditions: Parkinson Disease
• Interventions: Device: conventional Deep Brain Stimulation; Device: adaptive Deep Brain Stimulation

• Registration Number: NCT03422757
• Lead Sponsor: Newronika

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.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-12-15
• Study First Submitted QC: 2018-01-30
• Study First Posted: 2018-02-06
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-17
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
conventional DBS	conventional Deep Brain Stimulation	conventional Deep Brain Stimulation, by AlphaDBSvext.
adaptive DBS	adaptive Deep Brain Stimulation	adaptive Deep Brain Stimulation, by AlphaDBSvext.

Primary Outcome Measures

Name	Time	Method
Total Electrical Energy Delivered (TEED) to the patient	One day.	Difference in the TEED delivered to the patient in adaptive DBS versus conventional DBS mode.

Secondary Outcome Measures

Name	Time	Method
Unified Parkinson's Disease Rating Scale (UPDRS) part III	One day.	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.
Incidence of device related Adverse Events (safety and tolerability)	One day.	Number of device relate Adverse Events or abnormal vital signs.
Unified Dyskinesia Rating Scale (UDysRS)	One day.	Evaluation of dyskinesia through repeated clinical assessments (using UDysRS).

Trial Locations

Locations (4)

Centro Parkinson e Disturbi del Movimento ASST G.Pini- CTO; 🇮🇹 Milano, Italy

Fondazione Istituto Neurologico Nazionale Casimiro Mondino; 🇮🇹 Pavia, Italy

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

IRCCS Istituto Ortopedico Galeazzi; 🇮🇹 Milano, Italy