In Vivo Measurement of the Accuracy of the "Neurolocate" Module of the Neurosurgical Robot "Neuromate" in Its Application to Deep Brain Stimulation (NEUROLOCATE)

June 9, 2023 updated by: Centre Hospitalier Universitaire de Nice
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Nice, France, 06000
        • Department of Neurosurgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients requiring a stereotactic robot-guided deep brain stimulation procedure (Parkinson's disease, disabling tremor, dystonia)

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stereotactic robot-guided deep brain stimulation procedure
Patients requiring a stereotactic robot-guided deep brain stimulation procedure (Parkinson's disease, disabling tremor, dystonia)
Procedure: deep brain stimulation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occupancy time of the operating room
Time Frame: Day of intervention
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)
Day of intervention
comfort of the patient
Time Frame: Within 3 days after intervention
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).
Within 3 days after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Denys FONTAINE, Centre Hospitalier Universitaire de Nice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2021

Primary Completion (Actual)

January 7, 2022

Study Completion (Actual)

January 7, 2023

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 14, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 9, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-PP-22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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