Sub-thalamic Nucleus Stimulation in Parkinson Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Deep brain stimulation (DBS) is an established procedure for the symptomatic treatment of
      Parkinson's disease. This procedure performed in two steps using electrophysiology. This
      study is a prospective, randomized and monocentric study to compare two DBS procedures with
      or without electrophysiology.

      A better control of targeting and trajectory is necessary before not using electrophysiology,
      which is the reference procedure. A new definition of sub thalamic nuclei with new MRI
      stereotactic landmarks, the use of surgical robot (Neuromata Renishaw) and the use of
      operative imaging (O-arm) could allow the implantation of electrode in sub-thalamic nuclei
      without the need of electrophysiology.

      Two groups of patients will be followed: a first group of patients with a procedure under
      general anesthesia alone without electrophysiological stimulation and a second smaller group
      of patients with a first step of electrode implantation under awake surgery with
      electrophysiological stimulation followed by a second step under general anesthesia for the
      implantation of stimulator.

      Clinical results will be assessed at 6 months after implantation.
    

Detailed description: 
      Deep brain stimulation (DBS) is an established procedure for the symptomatic treatment of
      Parkinson's disease. This procedure performed in two steps using electrophysiology (Limousin
      et al., 1995) to register the activity of the sub-thalamic nucleus and test the efficacy of
      stimulation while the patient is awake. A second procedure is needed a few days later to
      implant the stimulation device under general anaesthesia. The duration of the first procedure
      is long because of a necessary time of deep stimulation to control the target before
      definitive implantation. Firstly, the long time of procedure causes pain for the patient.
      Secondly, the time of procedure, and thus of electrophysiology, is correlated with a rate of
      device infection of 5 % - 6 % (Hamani et al., 2006; Kenney et al., 2007; Sillay et al., 2008;
      Doshi et al., 2011). Thirdly, the introduction of several microelectrodes increases the risk
      of operative and postoperative haemorrhages, estimated at 1 % (Kenney et al., 2007; Sansur et
      al., 2007; Voges et al., 2007; Bhatia et al., 2008). Moreover, Foltynie et al. (2011)
      described 12/79 patients treated under general anaesthesia alone with the same post operative
      results than those who were firstly treated under local anaesthesia.

      A better control of targeting and trajectory is necessary before not using electrophysiology,
      which is the reference procedure. A new definition of sub thalamic nuclei with new MRI
      stereotactic landmarks, the use of surgical robot (Neuromata Renishaw) and the use of
      operative imaging (O-arm) could allow the implantation of electrode in sub-thalamic nuclei
      without the need of electrophysiology. (Caire et al. 2012, In press).

      This study is a prospective, randomized and monocentric study. The randomization will be made
      according to a ratio 2:1 in favour of the technique without electrophysiology. Two groups of
      patients will be followed: a first group of patients with a procedure under general
      anesthesia alone without electrophysiological stimulation and a second smaller group of
      patients with a first step of electrode implantation under awake surgery with
      electrophysiological stimulation followed by a second step under general anesthesia.

      After a preoperative assessment, a end-point evaluation at 6 months after implantation will
      complete the follow-up.

      The stimulation efficacy (UPDRS-3) and the post operative adverse effects will be noticed.

      This study will also evaluate the occurrence of a post-traumatic stress disorder (PTSD) in
      Parkinson disease patients operated under deep brain stimulation.
    

Intervention name(s): New targeting procedure without electrophysiology; Classical neurosurgical procedure
Intervention type(s): Procedure; Procedure
Intervention description(s): It is a neurosurgical procedure of electrodes implantation in the sub thalamic nuclei under general anaesthesia using a new targeting procedure without electrophysiology.; It is a neurosurgical procedure of electrodes implantation in the sub thalamic nuclei under awake surgery with electrophysiological control. A second surgical step is performed to implant the subcutaneous stimulation device, under general anesthesia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Deep Brain Stimulation (DBS); Parkinson disease; Stereotaxis Technique; Subthalamic nucleus