Feasibility, Safety and Efficacy of Deep Brain Stimulation for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this investigation is to obtain a preliminary indication of the feasibility,
      safety and efficacy of capsular deep brain stimulation (DBS) as a treatment for intractable
      depression. Also, to to learn about a new treatment for severe depression that has not
      improved enough despite long-term treatment with medications and behavior therapy. The new
      treatment is called deep brain stimulation, or DBS.

      In DBS, thin wires are used to carry electric current to parts of the brain that are thought
      to be involved in producing depression symptoms. Two wires are implanted surgically, and
      attached to battery packs implanted under the skin of the new chest below your collar bone.
    

Detailed description: 
      This protocol proposes a pilot/feasibility clinical study of therapeutic benefits of ventral
      capsule/ventral striatum deep brain stimulation (DBS) as a treatment in ten patients with
      intractable major depression (MD). Conservative estimates place MD's prevalence at 2.6% to
      5.5% in men and 6.0% to 11.8% in women. Most conservative studies estimate a 20% complete
      refractoriness to medical and psychotherapeutic regimens. Given the prevalence of major
      depression in the general population, over 3.5 million Americans would be expected to
      manifest refractory illness if all those with depression received treatment. Study subjects
      will have MD of disabling severity, intractable to prolonged treatment attempts with
      conventional medication and pschotherapies. They must also have had electroconvulsive
      therapy. These refractory patients would be candidates for a destructive/lesioning brain
      surgery such as a radiofrequency cingulotomy.

      These MD patients are analogous to medically intractable Parkinson's disease and tremor
      patients who until recently underwent similar destructive surgeries such as a pallidotomy or
      thalamotomy. The use of DBS technology with its inherent advantage of being fully reversible
      and adjustable has become standard of care for these disabled patients. Studies have
      demonstrated improved safety and efficacy of DBS over lesioning.

      Recently, DBS technology has been employed in the lesioning target of the anterior limb of
      the internal capsule for OCD. These preliminary studies in Europe and now the US, are
      demonstrating improved outcomes for refractory OCD patients with regard to their OC symptoms
      as well as depressed mood. This amelioration of mood provides the basis on which anterior
      internal capsule DBS may help major depression patients.

      Based on this rationale, we believe that DBS is a viable therapeutic surgical option in this
      group of severely ill MD patients. The standard DBS stereotactic surgical techniques employed
      by the CCF team in hundreds of movement disorder patients will be used. The DBS electrodes
      will be implanted bilaterally in the anterior limb of the internal capsule and connected
      subcutaneously to subclavicular programmable pulse generators.
    

Intervention name(s): Deep Brain Stimulations for Depression
Intervention type(s): Device
Intervention description(s): Deep Brain Stimulations for Depression
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DBS; Depression