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

Toulouse University Hospital

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Procedure: Standard Stereotactic imaging; Procedure: O-Arm Stereotactic imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT05910008

2023-A00871-44 (Other Identifier)

RC31/22/0489

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a diagnosis of idiopathic Parkinson's disease at the stage of motor fluctuations despite optimal medical treatment
• Indication for Deep Brain Stimulation (DBS) of the subthalamic nucleus approved by the local multidisciplinary deep brain stimulation committee after an operability assessment (see Appendix)
• Informed and signed patient consent
• Affiliation to a social security scheme

Exclusion criteria

• Significant cognitive decline assessed in a dedicated multidisciplinary consultation
• Contraindication to Magnetic Resonance Imaging (MRI)
• Presence of pathologies contraindicating deep brain stimulation
• No contraceptive treatment for women of childbearing age
• Pregnant or breastfeeding woman
• Anticoagulant or antiaggregant treatment that cannot be stopped
• Persons under legal protection (persons deprived of liberty or incapable of giving consent or under guardianship or tutelage...)
• Patient with severe psychiatric disorders

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

O-Arm stereotactic imaging

Experimental group

Description:

Imaging is performing directly in the operating room.

Treatment:

Procedure: O-Arm Stereotactic imaging

Standard stereotactic imaging

Active Comparator group

Description:

Imaging is performing in Radiology department.

Treatment:

Procedure: Standard Stereotactic imaging