Parkinson DiseaseNEUROLOCATENCT04712552
In Vivo Measurement of the Accuracy of the "Neurolocate" Module of the Neurosurgical Robot "Neuromate" in Its Application to Deep Brain Stimulation
An observational study of Parkinson Disease and Dystonia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The purpose of this study is to evaluate the accuracy of the Neurolocate recording system of the neurosurgical robot Neuromate, marketed by Renishaw, in order to optimize surgical procedures, costs and patient comfort. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Parkinson Disease, Dystonia, Tremor
- What is being tested?
- deep brain stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2021to 7 Jan 2023
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring a stereotactic robot-guided deep brain stimulation procedure (Parkinson's disease, disabling tremor, dystonia)
Who may be able to join
- Patients aged 18 to 70 years old requiring a stereotactic robot-guided deep brain stimulation procedure
- Signature of the Informed Consent Form
- Affiliation to the French social security system
Who cannot join
- Contraindication to MRI
- Hypersensitivity to gadoteric acid, meglumine or any product containing gadolinium.
- Anterior and posterior commissure anatomy modifying brain anatomy
- Patient unable to complete the Comfort Questionnaire due to cognitive or speech impairment
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the accuracy of the Neurolocate recording system of the neurosurgical robot Neuromate, marketed by Renishaw, in order to optimize surgical procedures, costs and patient comfort.
Read the detailed description
Robotic neurosurgery has been developed for nearly 25 years and offers neurosurgeons many advantages, including increased precision.
Accuracy is a key point for stereotactic neurosurgical procedures, particularly for deep brain stimulation electrode implantations.
The accuracy of the Neuromate robot was measured in stereotactic framed and frameless mode in vitro and in vivo during stereo-electroencephalography procedures. Investigators also evaluated the actual accuracy of its application in routine deep brain stimulation procedures using a measurement system independent of the robot itself and the manufacturer. We showed that the average in vivo accuracy was 0.86 mm and the maximum error was 1.55 mm. This accuracy is at least similar to the accuracy of stereotactic frame arms and is compatible with the accuracy required in deep brain stimulation procedures.
The Neurolocate device is a new non-invasive, frameless patient matching module designed for use with the Neuromate stereotactic robot.
The main advantages of the Neurolocate system are that it is less invasive than screw-on markers, simplifies the surgical procedure and reduces the duration of the surgery The accuracy of the Neurolocate frameless recording system was evaluated in vitro and in vivo for robotic stereo-electroencephalography trajectories in epileptic patients and compared to the accuracy of conventional recording using a stereotactic frame.
However, the accuracy of the Neurolocate recording system has never been measured in vivo during deep brain stimulation procedures.
- Conditions
- Parkinson Disease, Dystonia, Tremor
- Being tested
- deep brain stimulation
- Medical subject headings
- Parkinson Disease, Dystonia, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep brain stimulationProcedure or surgery
On the day of surgery, under general anesthesia, a Fischer ZD frame will be attached to the skull. A T1-weighted 3D MRI with gadolinium will be performed.
Investigators will plan on this MRI, anatomical targets and deep brain trajectories using the NeuroInspire surgical planning software.
The patient will be attached to the base of the robot through the frame. Registration will be performed using the Neurolocate method after the acquisition of 3D CT images using the O-arm. The Neurolocate recording is based on radiographic images.The 3D MRI will be merged with the 3D tomography images taken with the O-arm to co-register the trajectories planned on the MRI in the robot space The surgical procedure will be performed as usual by milling the bone at the entry point and inserting under robotic guidance an electrode through a guide tube to the intended target.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic robot-guided deep brain stimulation procedure | Patients requiring a stereotactic robot-guided deep brain stimulation procedure (Parkinson's disease, disabling tremor, dystonia) Receives: Procedure: deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Euclidean distance between the point theoretically aimed at by the robot and the point actually reached
Precision measurement: Comparison of the Euclidean distance between the point theoretically aimed at by the robot and the point actually reached, based on their respective stereotactic coordinates with respect to the anterior and posterior commissure line
Measured: Day of intervention
Secondary outcomes (2)
Occupancy time of the operating room
Occupancy time of the operating room between the entry of the patient into the operating room and his exit, comparing the methods based on Neurolocate and the classical method with frame (historical data)
Measured: Day of intervention
comfort of the patient
Evaluation of the invasiveness of the technique and the comfort of the patient through postoperative interviews, assessing their comfort on a 10-point scale and comparing methods based on Neurolocate and the classic "frame-based" method (historical data).
Measured: Within 3 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start26 Jan 2021
- Primary completion7 Jan 2022
- Study completion7 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denys FONTAINE, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712552
- Sponsor's protocol ID
- 19-PP-22
- Acronym
- NEUROLOCATE
- Status last verified
- Mar 2026
- First submitted
- 14 Jan 2021
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Almairac F, Leplus A, Mondot L, Fontaine D. A New Noninvasive Frameless Registration System for Stereotactic Cranial Biopsy: A Technical Note. Oper Neurosurg. 2023 Jan 1;24(1):64-67. doi: 10.1227/ons.0000000000000426. Epub 2022 Sep 26.
PubMed 36227183Fontaine D, Almairac F, Chiapello B, Leplus A. Application accuracy of Neuromate robot-guided deep brain stimulation procedures using the non-invasive frameless Neurolocate registration system. Int J Med Robot. 2023 Dec 13:e2610. doi: 10.1002/rcs.2610. Online ahead of print.
PubMed 38093525
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Measurement of the Accuracy of the "Neurolocate" Module of the Neurosurgical Robot "Neuromate" in Its Application to Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT04712552
- Acronym / sponsor ID
- NEUROLOCATE / 19-PP-22
- Conditions
- Parkinson Disease, Dystonia, Tremor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 7 Jan 2022 (actual)
- Study completion
- 7 Jan 2023 (actual)
- First posted
- 15 Jan 2021 (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.
The purpose of this study is to evaluate the accuracy of the Neurolocate recording system of the neurosurgical robot Neuromate, marketed by Renishaw, in order to optimize surgical procedures, costs and patient comfort.
Detailed description
Robotic neurosurgery has been developed for nearly 25 years and offers neurosurgeons many advantages, including increased precision.
Accuracy is a key point for stereotactic neurosurgical procedures, particularly for deep brain stimulation electrode implantations.
The accuracy of the Neuromate robot was measured in stereotactic framed and frameless mode in vitro and in vivo during stereo-electroencephalography procedures. Investigators also evaluated the actual accuracy of its application in routine deep brain stimulation procedures using a measurement system independent of the robot itself and the manufacturer. We showed that the average in vivo accuracy was 0.86 mm and the maximum error was 1.55 mm. This accuracy is at least similar to the accuracy of stereotactic frame arms and is compatible with the accuracy required in deep brain stimulation procedures.
The Neurolocate device is a new non-invasive, frameless patient matching module designed for use with the Neuromate stereotactic robot.
The main advantages of the Neurolocate system are that it is less invasive than screw-on markers, simplifies the surgical procedure and reduces the duration of the surgery The accuracy of the Neurolocate frameless recording system was evaluated in vitro and in vivo for robotic stereo-electroencephalography trajectories in epileptic patients and compared to the accuracy of conventional recording using a stereotactic frame.
However, the accuracy of the Neurolocate recording system has never been measured in vivo during deep brain stimulation procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic robot-guided deep brain stimulation procedure | – | Procedure: deep brain stimulationPatients requiring a stereotactic robot-guided deep brain stimulation procedure (Parkinson's disease, disabling tremor, dystonia) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring a stereotactic robot-guided deep brain stimulation procedure (Parkinson's disease, disabling tremor, dystonia)
Key inclusion criteria (3 listed)
- Patients aged 18 to 70 years old requiring a stereotactic robot-guided deep brain stimulation procedure
- Signature of the Informed Consent Form
- Affiliation to the French social security system
Key exclusion criteria (5 listed)
- Contraindication to MRI
- Hypersensitivity to gadoteric acid, meglumine or any product containing gadolinium.
- Anterior and posterior commissure anatomy modifying brain anatomy
- Patient unable to complete the Comfort Questionnaire due to cognitive or speech impairment
- Pregnant or breastfeeding women
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 |
|---|---|---|
| deep brain stimulationOn the day of surgery, under general anesthesia, a Fischer ZD frame will be attached to the skull. A T1-weighted 3D MRI with gadolinium will be performed. Investigators will plan on this MRI, anatomical targets and deep brain trajectories using the NeuroInspire surgical planning software. The patient will be attached to the base of the robot through the frame. Registration will be performed using the Neurolocate method after the acquisition of 3D CT images using the O-arm. The Neurolocate recording is based on radiographic images.The 3D MRI will be merged with the 3D tomography images taken with the O-arm to co-register the trajectories planned on the MRI in the robot space The surgical procedure will be performed as usual by milling the bone at the entry point and inserting under robotic guidance an electrode through a guide tube to the intended target. | Procedure or surgery | Stereotactic robot-guided deep brain stimulation procedure |
Primary outcome
Euclidean distance between the point theoretically aimed at by the robot and the point actually reached
Time frame: Day of intervention
Precision measurement: Comparison of the Euclidean distance between the point theoretically aimed at by the robot and the point actually reached, based on their respective stereotactic coordinates with respect to the anterior and posterior commissure line
2 secondary outcomes
Occupancy time of the operating room
Time frame: Day of intervention
comfort of the patient
Time frame: Within 3 days after intervention
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 24 Mar 2026.
- Background: PubMed 36227183Almairac F, Leplus A, Mondot L, Fontaine D. A New Noninvasive Frameless Registration System for Stereotactic Cranial Biopsy: A Technical Note. Oper Neurosurg. 2023 Jan 1;24(1):64-67. doi: 10.1227/ons.0000000000000426. Epub 2022 Sep 26.
- Results publication: PubMed 38093525Fontaine D, Almairac F, Chiapello B, Leplus A. Application accuracy of Neuromate robot-guided deep brain stimulation procedures using the non-invasive frameless Neurolocate registration system. Int J Med Robot. 2023 Dec 13:e2610. doi: 10.1002/rcs.2610. Online ahead of print.
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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.
Denys FONTAINE principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Dystonia, run by Centre Hospitalier Universitaire de Nice 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 3 inclusion and 5 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 24 Mar 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?
Euclidean distance between the point theoretically aimed at by the robot and the point actually reached (time frame: Day of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04712552, which also lists 2 linked publications.
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 24 Mar 2026.