Antidepressant Effect of Deep Brain Stimulation in Parkinson's Disease Patients
Condition: Parkinson's Disease; Major Depressive Disorder
MeSH terms: Parkinson Disease; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is:

        1. To determine, in the context of a prospective clinical trial, whether stimulation
           parameters in PD patients treated with DBS, are associated with antidepressant effects.

        2. To determine whether these antidepressant effects are related to or independent of
           changes in the motor features of PD.

        3. To establish a computerized database that includes stimulation parameters and clinical
           parameters in PD patients treated with DBS.

        4. To develop a computer-assisted decision making protocol for programming of DBS
           parameters in both depressed and non-depressed PD patients.
    

Detailed description: 
      Depressive symptoms of PD patients are major predictors of their prognosis and quality of
      life. Therefore, successful treatment of depression is crucial in PD patients. Using deep
      brain stimulation as an antidepressant (or to augment a standard antidepressant) could be a
      promising new direction. The hypothesis to be tested in the current project is that treatment
      with deep brain stimulation will improve both the neurological and the psychiatric
      (depressive) symptoms of PD. It is further hypothesized that the improvement in depressive
      symptoms will not be a simple consequence of improvement in neurological status. Data from
      this open label study will form the basis for planning a larger scale controlled trial in
      depressed PD patients and exploratory studies in patients with major depression who do not
      have PD.

      Today, programming of DBS is based on the neurological evaluation of the motor features of
      PD. If our hypothesis is proven, i.e. parameter manipulation of DBS affects the mental
      features of PD, it is crucial to establish a valid database that will enable to study these
      effects. Moreover, such a detailed database will be the basis for the development of a
      computer-assisted decision making protocol for programming of DBS. A novel decision making
      protocol will maximize the benefits of DBS in both depressed and non-depressed PD patients.
    

Intervention name(s): DBS parameters setting
Intervention type(s): Device
Intervention description(s): DBS parameters will be set to increase the DBS affected volume to include both the cognitive and limbic territories in addition to the dorso-lateral motor territories of the STN. This novel approach to parameter selection is directed to achieve improvement in cognitive and limbic as well as motor domains of PD. The patients will therefore be assessed for cognitive, limbic and motor state at multiple time points; there will be a baseline assessment prior to starting treatment (prior to DBS surgery and/or prior to parameters changes); thereafter assessments will follow the stimulation parameter changes; thereafter follow-up assessments at 6 - 12 months. Stimulation parameters will be changed every 2 weeks or earlier if an urgent clinical state emerges. Patients with depression will be monitored for antidepressant effects of stimulation changes. Patients without depression will be monitored for evidence of treatment emergent depression.
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's disease; Major depressive disorder; Deep brain stimulation