Reduce motor fluctuations with imaging
- Trial ID
- NCT05910008
- Official Title
- Evaluation of Intraoperative O-ARM Stereotactic Imaging Versus Conventional Pre-operative Stereotactic Imaging in Deep Brain Stimulation for Parkinson's Disease
- Goal
- Reduce motor fluctuations with imaging
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University Hospital, Toulouse
- Study Type
- INTERVENTIONAL
- Enrollment
- 24 participants
- Conditions
- Parkinson Disease
- Interventions
- O-Arm Stereotactic imaging, Standard Stereotactic imaging
Plain-Language Summary
The goal is to see whether using intraoperative O-ARM 3D imaging helps surgeons place subthalamic nucleus DBS leads more accurately and therefore control motor fluctuations better than relying on conventional preoperative imaging. O-ARM is a CT-style scanner used during the operation to give real-time 3D views of the brain and the lead so the surgeon can check and adjust placement on the spot; the imaging itself does not change medications, but more precise lead placement can improve symptom control and reduce later programming or levodopa adjustments. The trial is looking for adults 18 to 75 with idiopathic Parkinson's who have motor fluctuations despite optimized meds and who are approved for STN DBS, excluding those with major cognitive decline, MRI contraindications, severe psychiatric disorders, pregnancy, inability to stop certain blood thinners, or legal incapacity to consent.
Locations
- CHU de Toulouse, Toulouse, France
Frequently Asked Questions
- What is this trial testing?
- This trial is studying O-Arm Stereotactic imaging. The goal is to see whether using intraoperative O-ARM 3D imaging helps surgeons place subthalamic nucleus DBS leads more accurately and therefore control motor fluctuations better than relying on conventional preoperative imaging. O-ARM is a CT-style scanner used during the operation to give real-time 3D views of the brain and the lead so the surgeon can check and adjust placement on the spot; the imaging itself does not change medications, but more precise lead placement can improve symptom control and reduce later programming or levodopa adjustments. The trial is looking for adults 18 to 75 with idiopathic Parkinson's who have motor fluctuations despite optimized meds and who are approved for STN DBS, excluding those with major cognitive decline, MRI contraindications, severe psychiatric disorders, pregnancy, inability to stop certain blood thinners, or legal incapacity to consent.
- Who can participate?
- Participants must be between 18 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year.