Clinical trial NCT04712552: In Vivo Measurement of the Accuracy of the "Neurolocate" Module of the Neurosurgical Robot "Neuromate" in Its Application to Deep Brain Stimulation
Official title: In Vivo Measurement of the Accuracy of the "Neurolocate" Module of the Neurosurgical Robot "Neuromate" in Its Application to Deep Brain Stimulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Dystonia
Tremor
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring a stereotactic robot-guided deep brain stimulation procedure (Parkinson's disease, disabling tremor, dystonia)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Euclidean distance between the point theoretically aimed at by the robot and the point actually reached
timeFrame: Day of intervention
Secondary outcomes:
measure: Occupancy time of the operating room
timeFrame: Day of intervention
measure: comfort of the patient
timeFrame: Within 3 days after intervention
Other outcomes:
Locations:
city: Nice
country: France
facility: Department of neurosurgery
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Denys FONTAINE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Almairac F, Leplus A, Mondot L, Fontaine D. A New Noninvasive Frameless Registration System for Stereotactic Cranial Biopsy: A Technical Note. Oper Neurosurg (Hagerstown). 2023 Jan 1;24(1):64-67. doi: 10.1227/ons.0000000000000426. Epub 2022 Sep 26.