Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05910008
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-06-08
Brief Title:
O-ARM Stereotactic Imaging in Deep Brain Stimulation for Parkinsons Disease
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
Evaluation of Intraoperative O-ARM Stereotactic Imaging Versus Conventional Pre-operative Stereotactic Imaging in Deep Brain Stimulation for Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2024-05
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:
STEREOBLOC
Brief Summary:
During deep brain stimulation procedures in Parkinsons disease PD the most important prognostic element is the positioning of the surgical electrode in the subthalamic nucleus which is the anatomical target The main objective of this project is therefore to compare 2 techniques thanks to a prospective comparative randomised open-label study the use of O-ARM to acquire stereotactic imaging directly in the operating room and the standard technique requiring stereotactic imaging to be performed in the radiology department
Detailed Description:
Prior to electrode implantation we perform stereotactic imaging which requires the fixation of a stereotactic frame on the patients head before imaging Magnetic Resonance Imaging MRI Computed Tomography CT Currently it is necessary to transfer the patient to the imaging department outside of the operating room after the stereotactic frame has been placed for imaging either MRI or CT and then to return to the operating room to begin the electrode implantation procedure Since 2016 the new generation O-Arm 2 allows the acquisition of stereotactic imaging with the stereotactic frame in place by increasing the field of view 40 cm versus 20 cm previously directly in the operating room As a result the transfer step to the MRI and CT scanner preoperatively may no longer be necessary and the procedure can be started more quickly with greater comfort and safety for the patient and the anaesthesia team Several teams around the world have begun to use framed O-Arm as the gold standard for stereotactic imaging However no randomised controlled study has been performed to date comparing O-Arm stereotactic imaging with pre-operative CT andor MRI reference imaging
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A00871-44 | OTHER | ID-RCB | None |