Using O-ARM imaging for deep brain stimulation in Parkinson's disease
Evaluation of Intraoperative O-ARM Stereotactic Imaging Versus Conventional Pre-operative Stereotactic Imaging in Deep Brain Stimulation for Parkinson's Disease
This study is testing whether using O-ARM imaging during deep brain stimulation for Parkinson's disease can make the procedure safer and more comfortable compared to the standard imaging method that requires moving the patient.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT05910008 on ClinicalTrials.gov |
What this trial studies
This project aims to compare two techniques for acquiring stereotactic imaging during deep brain stimulation procedures for Parkinson's disease. The study will evaluate the use of O-ARM imaging, which allows for imaging directly in the operating room, against the standard technique that requires patient transfer to a radiology department. By eliminating the need for patient transfer, the O-ARM technique may enhance comfort and safety while expediting the procedure. This is a prospective comparative randomized open-label study, as no previous randomized controlled studies have compared these two imaging methods.
Who should consider this trial
Good fit: Ideal candidates are patients with idiopathic Parkinson's disease experiencing motor fluctuations despite optimal medical treatment and who are approved for deep brain stimulation.
Not a fit: Patients with significant cognitive decline, contraindications to MRI, or severe psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and patient comfort during deep brain stimulation procedures.
How similar studies have performed: While several teams have begun using O-Arm as a gold standard, this is the first randomized controlled study comparing it with traditional imaging methods.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toulouse
- CHU de Toulouse — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Amaury De Barros, MD — University Hospital, Toulouse
- Study coordinator: Amaury De Barros, MD
- Email: debarros.a@chu-toulouse.fr
- Phone: 561779027
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.