In Vivo Measurement of the Accuracy of the "Neurolocate" Module of the Neurosurgical Robot "Neuromate" in Its Application to Deep Brain Stimulation
Condition: Parkinson Disease; Dystonia; Tremor
MeSH terms: Parkinson Disease; Dystonia
Study type: Observational

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.
    

Intervention name(s): deep brain stimulation
Intervention type(s): Procedure
Intervention description(s): 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.
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)