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

Centre Hospitalier Universitaire de Nice

Status: Completed

Conditions: Tremor; Dystonia; Parkinson Disease

Treatments: Procedure: deep brain stimulation

Study type: Observational

Funder types: Other

Identifiers

NCT04712552

19-PP-22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

18 participants in 1 patient group

Stereotactic robot-guided deep brain stimulation procedure

Description:

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

Treatment:

Procedure: deep brain stimulation