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

NCT05910008

CompletedNA

Sponsor: University Hospital, Toulouse

Conditions: Parkinson Disease

Interventions: O-Arm Stereotactic imaging, Standard Stereotactic imaging

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (1)
  • Toulouse, France