Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-25 @ 4:14 PM
Study NCT ID:
NCT03422757
Status:
TERMINATED
Last Update Posted:
2020-11-19
First Post:
2017-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Adaptive DBS Vs Conventional DBS in Patients With Parkinson's Disease
Sponsor:
Newronika
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company strategic decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: