Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04884412
Status:
RECRUITING
Last Update Posted:
2023-11-21
First Post:
2021-04-27
Brief Title:
Deep Brain Stimulation for Parkinsons Disease Probabilistic STN Targeting Under General Anaesthesia Without Micro-electrode Recordings vs Current Targeting Procedure
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Deep Brain Stimulation for Parkinsons Disease Probabilistic STN Targeting Under General Anaesthesia Without Micro-electrode Recordings MER vs Current Targeting Procedure
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PARKEO2
Brief Summary:
Deep brain stimulation DBS of the sub-thalamic nucleus STN has evolved over the past decades as a mainstream therapy for advanced Parkinsons disease PD The classical procedure consists in STN indirect targeting based on stereotactic atlases or statistical coordinates in AC-PC Anterior Commissure - Posterior Commissure referential along with target control and correction by micro-electrode recordings MER and awake clinical testing To avoid potential complications and patient discomfort related to current procedure asleep surgery without this control process has become more and more performed essentially thanks to the progress of neuroimaging allowing to STN visualization However it has been reported a relative inaccuracy between the radiological STN delimitated on several types of MRI sequences T2 T2 SWI and the per-operative electrophysiological findings As a result there are currently many types of STN-DBS procedures and the lack of standardization between techniques complicates the interpretation of postoperative results on anatomical electrophysiological and clinical points of view Furthermore to date it has not been proven that asleep surgery without MER and clinical controls is as effective as the standard procedure in a prospective controlled randomized clinical trial
Investigators hypothesize that the clinical-based 18 landmarks STN target will be precise enough to allow to perform surgery under general anesthesia without MER correction and accurate enough to achieve non inferior clinical results compared to what is usually done in each centre
The main objective is to compare at one year the of motor improvement after PARKEO 2-targeting asleep DBS without intraoperative MER versus the targeting procedure using intraoperative MER by the UPRDRS 3 Unified Parkinsons disease rating scale 3
Investigators hypothesize that the clinical-based 18 landmarks STN target will be precise enough to allow to perform surgery under general anesthesia without MER correction and accurate enough to achieve non inferior clinical results compared to what is usually done in each centre
The main objective is to compare at one year the of motor improvement after PARKEO 2-targeting asleep DBS without intraoperative MER versus the targeting procedure using intraoperative MER by the UPRDRS 3 Unified Parkinsons disease rating scale 3
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None