One Pass thalamIc aNd subthalamIc stimulatiON
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Main part of the study:

      Randomised, active controlled, double blinded (patient and observer blinded), monocentric
      trial with three treatments, three periods and six treatment sequences allocated according to
      a Williams design

      Open Label Extension:

      After study treatment as described above, patients will be treated unblinded in their
      preferred stimulation mode until 36 months after implantation.
    

Detailed description: 
      Tremor is the most salient symptom of Parkinson's disease (IPS=idiopathic Parkinson
      syndrome). Other symptoms are bradykinesia, rigidity and postural instability. As much as 75%
      of patients with IPS show resting tremor. Initially, tremor is typically unilateral and only
      visible in stress situation. In the later stage of the disease it becomes bilateral. The
      OPINION trial aims at the investigation of a combined approach to thalamic/subthalamic deep
      brain stimulation (DBS) for the treatment of patients with tremor dominant IPS or patients
      with equivalent type IPS who perceive tremor to be their dominant symptom. The planned
      approach will for the first time allow for the direct comparison of each condition in a
      homogeneous patient population and will furthermore allow an intra-individual comparison of
      the different stimulation conditions (Ventral intermediate nucleus (Vim/DRT) - Subthalamic
      nucleus (STN) - Vim/DRT+STN) with the outcome parameter "quality of life".

      Patients will be registered to the trial and will undergo screening procedures (for
      eligibility criteria please see Inclusion and Exclusion criteria). If the patient is eligible
      the Investigational Medical Device (IMD) will be implanted (which is the Vercise™ Deep Brain
      Stimulation System manufactured by Boston Scientific). After implantation the IMD will remain
      OFF for a period of 1 month.

      1 month after implantation treatment will be started. Patients will be randomized to one of
      the following 3 treatment groups: Subthalamic nucleus (STN) or Ventral intermediate nucleus
      (Vim/DRT) or combined stimulation (Vim/DRT+STN). Patients will undergo all three treatment
      groups each lasting 3 months. The patient is blinded meaning that study patients will not
      know what kind of treatment (e.g. mode/region of stimulation) they receive.

      10 months after implantation the final visit of the randomized study will be performed. After
      that, patients will be asked to take part in an open label extension phase of the study where
      they will be treated unblinded according to established guidelines and according to their own
      preferred stimulation mode, just as they would be in a clinical routine setting. The
      extension phase is concluded by an end of study visit at 36 months after implantation.

      After the end of the trial, further treatment will be performed at the Department of
      Stereotactic and Functional Neurosurgery in Freiburg (Germany) according to established
      guidelines. Devices will be monitored 3-6 monthly Patient's medications will be adjusted as
      to the level of best treatment adjunct to stimulation.

      Study endpoints (e.g. quality of life) will be evaluated by a blinded rater. In addition, an
      external video rating will be performed.
    

Intervention name(s): Vercise™ Deep Brain Stimulation System
Intervention type(s): Device
Intervention description(s): The Vercise™ DBS System includes a Stimulator with DBS Leads for unilateral or bilateral stimulation. There are also DBS Extensions that allow the DBS Leads mounted in the skull to be extended to reach the Stimulator implanted near the clavicle.
The rechargeable Vercise DBS System utilizes current steering across eight contacts per DBS Lead to provide precise positioning of stimulation. The Stimulator is controlled by a handheld Remote Control, and can be interfaced with a Clinician's Programmer using the Bionic Navigator™ Software. Periodically, the Stimulator battery must be replenished with an RF (radiofrequency) charging device provided in the Patient DBS Charging Kit.
Other intervention name(s): Vercise DBS
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's Disease