NCT05910008

O-ARM Stereotactic Imaging in Deep Brain Stimulation for Parkinson's Disease

Evaluation of Intraoperative O-ARM Stereotactic Imaging Versus Conventional Pre-operative Stereotactic Imaging in Deep Brain Stimulation for Parkinson's Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

During deep brain stimulation procedures in Parkinson's 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 patient's 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 and/or MRI reference imaging.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
PROCEDURE	O-Arm Stereotactic imaging	Prior to electrode implantation, O-ARm stereotactic imaging (Magnetic Resonance Imaging)
PROCEDURE	Standard Stereotactic imaging	Prior to electrode implantation, standard stereotactic imaging (Magnetic Resonance Imaging)

Timeline

• Start date: 2024-02-05
• Primary completion: 2025-02-15
• Completion: 2025-06-15
• First posted: 2023-06-18
• Last updated: 2024-05-09

Locations

1 site across 1 country: France