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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
1 other identifier
interventional
6
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable parkinson-disease
Started Jun 2017
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 15, 2017
CompletedFirst Posted
Study publicly available on registry
February 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedNovember 19, 2020
November 1, 2020
1.6 years
December 15, 2017
November 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Incidence of device related Adverse Events (safety and tolerability)
One day.
Unified Parkinson's Disease Rating Scale (UPDRS) part III
One day.
Unified Dyskinesia Rating Scale (UDysRS)
One day.
Other Outcomes (5)
Time "off"
One day.
DBS Impairment Scale (DBS-IS)
One day.
Local field potentials (LFP) during gait analysis
Four hours.
- +2 more other outcomes
Study Arms (2)
adaptive DBS
EXPERIMENTALadaptive Deep Brain Stimulation, by AlphaDBSvext.
conventional DBS
ACTIVE COMPARATORconventional Deep Brain Stimulation, by AlphaDBSvext.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Newronikalead
Study Sites (4)
Centro Parkinson e Disturbi del Movimento ASST G.Pini- CTO
Milan, Italy
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milan, Italy
IRCCS Istituto Ortopedico Galeazzi
Milan, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Pavia, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2017
First Posted
February 6, 2018
Study Start
June 1, 2017
Primary Completion
December 30, 2018
Study Completion
December 30, 2018
Last Updated
November 19, 2020
Record last verified: 2020-11