Ignite Creation Date:
2024-05-06 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03696420
Status:
COMPLETED
Last Update Posted:
2021-09-21
First Post:
2018-10-03
Brief Title:
Probabilistic Targeting of the VIM
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Probabilistic Determination of the Ventro-intermediate Nucleus of the Thalamus VIM Coordinates From Radio-anatomical Landmarks on 15 Tesla MRI
Status:
COMPLETED
Status Verified Date:
2021-09
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:
PROBA-VIM
Brief Summary:
After having included the most improved patients by DBS among those implanted in Bordeaux Hospital University and having defined the most active plots on tremor by its prospective grading on Fahn-Tolosa-Marin FTM scale and accelerometry coordinates of active plots and landmarks will be calculated on post-operative imaging Association between landmarks and active plots coordinates will be modelled with machine-learning algorithms The aim is to retrieve the position of the VIM on the basis of the landmarks coordinates
Detailed Description:
The intermedius ventralis nucleus of the thalamus VIM which represents the target for deep brain stimulation DBS in essential tremor still remains invisible to imaging in spite of the development of new MR sequences The coordinates currently used in the classical ACPC system are so imprecise that per-operative electrophysiology is mandatory to locate the exact position of this target Micro-electrode recordings MER however improve hemorrhagic risk and may be poorly tolerated by patients operated on 7 to 8 hours under local anaesthesia Based on litterature review no one tried to retrieve the position of the VIM from anatomical landmarks coordinates in the era of MRI The patients operated will be clinically tested to define those very well improved by the stimulation Stimulation efficacy will be assessed by comparing the clinical evaluation FTM scale with and without stimulation and the four contacts of each electrode will be tested clinically with an accelerometer and an electromyography to determine which one is the most active on tremor Coordinates of the anatomical landmarks will be calculated on the pre-operative MRI and those of the active plots on the fusion between post-operative CT-scan and pre-operative MRI These coordinates will be analysed by machine-learning algorithms to create a model predicting the position of the active contacts from the coordinates of the landmarks
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