Status:
TERMINATED
Safety and Efficacy of Adaptive DBS Vs Conventional DBS in Patients With Parkinson's Disease
Lead Sponsor:
Newronika
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
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 blin...
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 stimu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2018
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03422757
Start Date
June 1 2017
End Date
December 30 2018
Last Update
November 19 2020
Active Locations (4)
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1
Centro Parkinson e Disturbi del Movimento ASST G.Pini- CTO
Milan, Italy
2
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milan, Italy
3
IRCCS Istituto Ortopedico Galeazzi
Milan, Italy
4
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Pavia, Italy