MER Versus MRI Guidance DBS in Parkinson's Disease
Condition: Idiopathic Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Most leading academic centers including Baylor College of Medicine (BCM) perform deep brain
      stimulation surgery in the awake patient using microelectrode recording to guide final
      electrode placement. Microelectrode recording is a means of analyzing the electrical activity
      of the brain, and assessing whether we have found the target for the deep brain stimulator
      electrode. However, no evidence exists that microelectrode recording improves patient
      outcomes. The use of microelectrode recording does extend the duration of surgery and there
      is evidence to suggest that microelectrode recording may increase the risk of bleeding in the
      brain during surgery.
    

Detailed description: 
      Patients who have been randomized into Group 1 will undergo DBS implantation while awake. On
      the morning of surgery, the patient will undergo placement of the stereotactic head frame
      under local anesthesia. A CT scan will be performed for stereotactic planning, which will be
      fused to a preoperatively obtained MRI. The coordinates for the planned target will be
      selected using standard coordinates based on known relationships with the anterior commissure
      - posterior commissure plane, along with anatomical structures visualized on the MRI scan.

      The surgery will be performed with the patient awake. Two simultaneous microelectrode tracks
      will be used for each DBS electrode to be implanted. If neither electrophysiological
      recording is adequate, additional MER tracks may be performed. Macro-stimulation will also be
      used to evaluate for clinical efficacy and stimulation induced side effects. The DBS
      electrode will be placed into the track with the optimal electrophysiological and clinical
      findings. The identical procedure will be followed for the contralateral side. A
      post-operative stereotactic CT scan will be performed to assess lead location and evaluate
      for intracranial bleeding.

      Patients who have been randomized into Group 2 will undergo DBS implantation under general
      anesthesia in an operating room equipped with an intraoperative MRI. Once under anesthesia
      the patient will be placed into a rigid head holder, and an MRI scan will be obtained to
      register the navigation system. The location for the holes in the skull will be identified,
      and the surgery will be commenced. Once the holes have been made in the skull and the dura
      has been opened, a second MRI scan will be obtained to identify the target. A ceramic stylet
      will then be stereotactically introduced to the target, and a third MRI sequence will be
      performed to verify the stylet is indeed at the desired target. The DBS electrode will then
      be implanted after removing the stylet. A post-operative stereotactic CT scan will be
      performed to assess lead location and evaluate for intracranial bleeding.

      Neither of the surgical groups will undergo investigational procedures. Both surgical
      techniques utilize FDA approved devices, used in the manner for which FDA approval was given.
      They represent two different, but both accepted, means for implanting deep brain stimulator
      electrodes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients between the ages of 30 and 79 Diagnosis of idiopathic Parkinson's disease
      
Keywords: PD; DBS