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

NCT04712552 | Completed

• 1 other identifier: 19-PP-22
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Dystonia; Tremor; Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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

  Day of intervention

Secondary Outcomes (2)

• Occupancy time of the operating room

  Day of intervention

• comfort of the patient

  Within 3 days after intervention

Study Arms (1)

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

Interventions

deep brain stimulation PROCEDURE

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.

Stereotactic robot-guided deep brain stimulation procedure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Department of neurosurgery

Nice, 06000, France

Location

Related Publications (2)

• 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.

  PMID: 36227183 BACKGROUND

• Fontaine 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.

  PMID: 38093525 RESULT

MeSH Terms

Conditions

Parkinson Disease; Dystonia; Tremor

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Denys FONTAINE

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 15, 2021
• Study Start: January 26, 2021
• Primary Completion: January 7, 2022
• Study Completion: January 7, 2023
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

FR (1)