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

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

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.

Study Overview

• Status: Terminated
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: adaptive Deep Brain Stimulation; Device: conventional Deep Brain Stimulation

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy
    • IRCCS Istituto Ortopedico Galeazzi
  • Milano, Italy
    • Centro Parkinson e Disturbi del Movimento ASST G.Pini- CTO
  • Milano, Italy
    • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
  • Pavia, Italy
    • Fondazione Istituto Neurologico Nazionale Casimiro Mondino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: adaptive DBS; adaptive Deep Brain Stimulation, by AlphaDBSvext.	Device: adaptive Deep Brain Stimulation; 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.
ACTIVE_COMPARATOR: conventional DBS; conventional Deep Brain Stimulation, by AlphaDBSvext.	Device: conventional Deep Brain Stimulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Electrical Energy Delivered (TEED) to the patient	Difference in the TEED delivered to the patient in adaptive DBS versus conventional DBS mode.	One day.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of device related Adverse Events (safety and tolerability)	Number of device relate Adverse Events or abnormal vital signs.	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.	One day.
Unified Dyskinesia Rating Scale (UDysRS)	Evaluation of dyskinesia through repeated clinical assessments (using UDysRS).	One day.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time "off"	Evaluation of time "off" through patient diary.	One day.
DBS Impairment Scale (DBS-IS)	Self assessment through questionnaire.	One day.
Local field potentials (LFP) during gait analysis	Evaluation of LFP recording from DBS electrodes during gait analysis.	Four hours.
Local field potentials (LFP) during speech analysis	Evaluation of LFP recording from DBS electrodes during speech analysis.	Four hours.
Local field potentials (LFP) during sleep analysis	Evaluation of LFP recording from DBS electrodes during sleep analysis.	One night.

Collaborators and Investigators

• Sponsor: Newronika

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ACTUAL): December 30, 2018
• Study Completion (ACTUAL): December 30, 2018

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: January 30, 2018
• First Posted (ACTUAL): February 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: NWK_aDBSext_01_2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No