NCT04712552

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-26
• Primary completion: 2022-01-07
• Completion: 2023-01-07
• First posted: 2021-01-15
• Last updated: 2026-03-24

Locations

1 site across 1 country: France