Parkinson DiseaseSTEREOBLOCNCT05910008
O-ARM Stereotactic Imaging in Deep Brain Stimulation for Parkinson's Disease
A study testing O-Arm Stereotactic imaging and Standard Stereotactic imaging in people with Parkinson Disease, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- O-Arm Stereotactic imaging and Standard Stereotactic imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2024to 14 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Intraoperative O-ARM Stereotactic Imaging Versus Conventional Pre-operative Stereotactic Imaging in Deep Brain Stimulation for Parkinson's Disease
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- O-Arm Stereotactic imaging, Standard Stereotactic imaging
- Keywords
- Stereotactic imaging, Deep Brain Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O-Arm Stereotactic imagingProcedure or surgery
Prior to electrode implantation, O-ARm stereotactic imaging (Magnetic Resonance Imaging)
Standard Stereotactic imagingProcedure or surgery
Prior to electrode implantation, standard stereotactic imaging (Magnetic Resonance Imaging)
| Study group | Role | What they receive |
|---|---|---|
| O-Arm stereotactic imaging | Experimental | Imaging is performing directly in the operating room. Receives: Procedure: O-Arm Stereotactic imaging |
| Standard stereotactic imaging | Active comparator | Imaging is performing in Radiology department. Receives: Procedure: Standard Stereotactic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absolute accuracy of Deep Brain Stimulation electrode implantation
The radial distance between the theoretical target and the electrode in the plane of the target regardless of the chosen trajectory (central, anterior, lateral). This distance corresponds to the minimum error between the target and the electrode. This measurement is made from the postoperative brain scan.
Measured: 48 hours
Secondary outcomes (7)
The anatomical accuracy of Deep Brain Stimulation electrode implantation
Automatic calculation of the vector distance between the middle of pad 1 on the electrode and the theoretical target by software.
Measured: 48 hours
Central and alternate position of the electrodes rate
Comparison of the anatomical location of the electrode compared to the anatomical target (subthalamic nucleus) after matching preoperative Magnetic Resonance Imaging (MRI) images
Measured: 1 day
Surgical Times
Time from the end of the stereotactic frame to the surgical incision and time from the entry into room to the exit from room after generator implantation.
Measured: 1 day
Clinical effectiveness
Comparison of The Unified Parkinson's Disease Rating Scale (UPDRS) II, III and IV scores between baseline and 6 months and then at 6 months between the 2 groups.
The UPDRS scale is composed of 47 items grouped into three parts : II, III and IV. Responses scale ranging from 0 (normal/no symptoms) to 4 (severe).
Measured: 6 months
Daily dose of Levodopa decrease
The change in Levodopa Equivalent Daily Dose (LEDD) before surgery and at 6 months compared between the 2 groups. This LEDD corresponds to the amount of antiparkinsonian treatments prescribed to the patient
Measured: 6 months
Adverse effect rate
Clinical reporting of patient events/adverse reactions
Measured: 6 months
Correlation between absolute accuracy and clinical effectiveness
Correlation between radial accuracy and UPDRS score for both groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start5 Feb 2024
- Primary completion16 Jun 2025
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amaury De Barros, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910008
- Sponsor's protocol ID
- RC31/22/0489
- Other IDs
- 2023-A00871-44
- Acronym
- STEREOBLOC
- Status last verified
- May 2026
- First submitted
- 8 Jun 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraoperative O-ARM Stereotactic Imaging Versus Conventional Pre-operative Stereotactic Imaging in Deep Brain Stimulation for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05910008
- Acronym / sponsor ID
- STEREOBLOC / RC31/22/0489
- Conditions
- Parkinson Disease
- Keywords
- Stereotactic imaging, Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| O-Arm stereotactic imaging | Experimental | Procedure: O-Arm Stereotactic imagingImaging is performing directly in the operating room. |
| Standard stereotactic imaging | Active comparator | Procedure: Standard Stereotactic imagingImaging is performing in Radiology department. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| O-Arm Stereotactic imagingPrior to electrode implantation, O-ARm stereotactic imaging (Magnetic Resonance Imaging) | Procedure or surgery | O-Arm stereotactic imaging |
| Standard Stereotactic imagingPrior to electrode implantation, standard stereotactic imaging (Magnetic Resonance Imaging) | Procedure or surgery | Standard stereotactic imaging |
Primary outcome
The absolute accuracy of Deep Brain Stimulation electrode implantation
Time frame: 48 hours
The radial distance between the theoretical target and the electrode in the plane of the target regardless of the chosen trajectory (central, anterior, lateral). This distance corresponds to the minimum error between the target and the electrode. This measurement is made from the postoperative brain scan.
7 secondary outcomes
The anatomical accuracy of Deep Brain Stimulation electrode implantation
Time frame: 48 hours
Central and alternate position of the electrodes rate
Time frame: 1 day
Surgical Times
Time frame: 1 day
Clinical effectiveness
Time frame: 6 months
Daily dose of Levodopa decrease
Time frame: 6 months
Adverse effect rate
Time frame: 6 months
Correlation between absolute accuracy and clinical effectiveness
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amaury De Barros, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing O-Arm Stereotactic imaging and Standard Stereotactic imaging in people with Parkinson Disease, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The absolute accuracy of Deep Brain Stimulation electrode implantation (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.