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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03422757
• Other study ID #: NWK_aDBSext_01_2017
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: November 2020
• Source: Newronika
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Newronika

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time "off"	Evaluation of time "off" through patient diary.	One day.
Other	DBS Impairment Scale (DBS-IS)	Self assessment through questionnaire.	One day.
Other	Local field potentials (LFP) during gait analysis	Evaluation of LFP recording from DBS electrodes during gait analysis.	Four hours.
Other	Local field potentials (LFP) during speech analysis	Evaluation of LFP recording from DBS electrodes during speech analysis.	Four hours.
Other	Local field potentials (LFP) during sleep analysis	Evaluation of LFP recording from DBS electrodes during sleep analysis.	One night.
Primary	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	Incidence of device related Adverse Events (safety and tolerability)	Number of device relate Adverse Events or abnormal vital signs.	One day.
Secondary	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.
Secondary	Unified Dyskinesia Rating Scale (UDysRS)	Evaluation of dyskinesia through repeated clinical assessments (using UDysRS).	One day.