Clinical trial NCT05910008: O-ARM Stereotactic Imaging in Deep Brain Stimulation for Parkinson's Disease
Official title: Evaluation of Intraoperative O-ARM Stereotactic Imaging Versus Conventional Pre-operative Stereotactic Imaging in Deep Brain Stimulation for Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Stereotactic imaging
Deep Brain Stimulation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The absolute accuracy of Deep Brain Stimulation electrode implantation
timeFrame: 48 hours
Secondary outcomes:
measure: The anatomical accuracy of Deep Brain Stimulation electrode implantation
timeFrame: 48 hours
measure: Central and alternate position of the electrodes rate
timeFrame: 1 day
measure: Surgical Times
timeFrame: 1 day
measure: Clinical effectiveness
timeFrame: 6 months
measure: Daily dose of Levodopa decrease
timeFrame: 6 months
measure: Adverse effect rate
timeFrame: 6 months
measure: Correlation between absolute accuracy and clinical effectiveness
timeFrame: 6 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Amaury De Barros, MD
role: PRINCIPAL_INVESTIGATOR
References: