Electrophysiological Recordings of Deep Brain Stimulation in the Basal Ganglia
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The pathology of Parkinson's disease (PD) and the mechanism of Deep Brain Stimulation surgery
      (DBS) are not completely understood. The recording data that is used routinely as part of the
      procedure to map the target structures, however, may be analyzed in order to better
      understand the neural network dynamics in PD. The purpose of the study is to perform
      simultaneous neural recordings from sub-cortical structures (e.g. subthalamic nucleus [STN]
      or globus pallidus internus [GPi]) and the cerebral cortex. These simultaneous recordings may
      provide insight in the pathology of PD and the mechanism of DBS. The researchers will also
      study the effects of anesthesia level on neuron synchronization . Recordings with micro-ECoG
      grid electrodes in the cortex show improved spatial resolution and these will be used to gain
      better understanding of cortical network dynamics and the synchronization with subcortical
      structures.
    

Detailed description: 
      Subjects will be identified exclusively from the researchers' clinical practice for
      evaluation of DBS surgical candidacy for Parkinson's disease. Once it is determined that a
      patient is an appropriate candidate for DBS placement (multidisciplinary team consensus) and
      has met inclusion criteria,the researchers will discuss the study with the subject and
      explain the rationale for the study as well as the implications the subject's participation
      has to their treatment. Informed consent will be obtained prior to study procedures being
      performed. Subjects will be in the study from the time of enrollment before surgery until all
      post-operative visits and tests are completed, usually by 6 months after surgery. Follow-up
      during this time will consist of the standard follow-up schedule that all patients who
      undergo DBS follow. This includes a clinic visit at 10-14 days, 12 weeks, and 6 months after
      DBS surgery. Subjects will also have a follow-up neurocognitive evaluation consisting of the
      same evaluative tests administered pre-operatively. These post-operative visits are standard
      for all patients undergoing DBS for Parkinson's.
    

Intervention name(s): Deep Brain Stimulation
Intervention type(s): Device
Intervention description(s): Subjects will have awake or asleep DBS surgery with STN or GPi placement. Microelectrode recordings will define the electrophysiological target prior to lead implantation. Cortical recordings will be done using µECoG grids (2.0 x 0.8 cm) placed over the cortex through the same burr hole used for lead implantation. Neural recordings will be made continuously throughout the procedure: before, during, and after DBS, and at all levels of anesthesia. A pulse generator will be connected and implanted either during the operation or within 7-10 days post-operatively. Subjects will be admitted overnight for observation with anticipated discharge the next morning. The researchers will also be collecting other routine data points (length of surgery, stereotactic accuracy, length of hospital stay, and post-operative complications).
Other intervention name(s): Activa PC Neurostimulator Model 37601 (Medtronic)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Deep Brain Stimulation