NCT05910008Completed
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
Source: ClinicalTrials.gov · Last updated 7 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 8 Jun 2023
- Start date
- 5 Feb 2024
- Primary completion date
- 16 Jun 2025
- Lead sponsor
- University Hospital, Toulouse
- Diseases
- Parkinson disease
- NCT number
- NCT05910008
What you commit to
- Study type: Interventional
- Participants enrolled: 24
- From 5 Feb 2024 to the primary completion date, 16 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient with severe psychiatric disorders
Age
- No contraceptive treatment for women of childbearing age
Other
- Significant cognitive decline assessed in a dedicated multidisciplinary consultation
- Contraindication to Magnetic Resonance Imaging (MRI)
- Presence of pathologies contraindicating deep brain stimulation
- 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...)
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.