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

Completed

• Conditions: Tremor; Parkinson Disease; Dystonia
• Interventions: Procedure: deep brain stimulation

• Registration Number: NCT04712552
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief 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.

Study Timeline

• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-15
• Study Start: 2021-01-26
• Primary Completion: 2022-01-07
• Study Completion: 2023-01-07
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-09
• Last Update Posted: 2023-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Euclidean distance between the point theoretically aimed at by the robot and the point actually reached	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

Secondary Outcome Measures

Name	Time	Method
Occupancy time of the operating room	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)
comfort of the patient	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).

Trial Locations

Locations (1)

Department of neurosurgery; 🇫🇷 Nice, France