Deep Brain Stimulation for the Treatment of Refractory Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      Bipolar Disorder (BD) is among the most comon and challenging conditions in psychiatry.
      Although episodes of mania and hypomania define the different types of the disorder, the
      clinical picture is one dominated by depressed mood and agitation. The mainstay of BD
      treatment has thus far been pharmacologic, but many patients remain severely disabled by
      their condition, despite the best available medical treatment. The successful use of deep
      brain stimulation (DBS) in movement disorders, and its promising results in major depressive
      disorder (MDD), has led researchers to consider its use in highly selected refractory cases
      of BD. Evidence form the imaging and circuitry literature suggests that similar underlying
      dyfunctional anatomic structures subserve both MDD and BD, indicating that modulation of key
      structures, can lead to an amelioration of symptoms and mood stabilization. Here, we propose
      a phase I clinical trial to evaluate the safety of DBS in BD.
    

Detailed description: 
      Bipolar disorder (BD) is a complex and disabling disorder that is among the most challenging
      diagnoses in psychiatry. Although episodes of mania and hypomania define the different types
      of the disorder, the clinical picture is one dominated by depressed mood and agitation.
      Detection and diagnosis of BD remains a challenge, as most individuals with BD spend many
      years misdiagnosed as major depression disorder (MDD), often leading to under-treatment or
      inappropriate treatment. Several studies have attempted to elucidate features of a major
      depressive episode that indicate an underlying diagnosis of MDD versus bipolar depression.

      During the last fifteen years, there have been significant advances in our understanding of
      the pathophysiology and relevant neuroanatomy and neurocircuitry underlying mood disorders.
      Much of that progress has been made as a result of technological advances in neuroimaging,
      both structural and functional.

      Deep Brain Stimulation is a neurosurgical tool has been used for over twenty-five years to
      treat various neurologic and psychiatric conditions. DBS is believed to work by using small
      amounts of electricity to disrupt the activity of brain structures that produce troublesome
      symptoms. In the case of Parkinson's disease, DBS is successful in treating the tremor and
      general slowing that are major parts of that condition. DBS has also been used in psychiatric
      patients, both as part of treatment, in cases of Obsessive-Compulsive Disorder (OCD), and
      research, in cases of Depression. The successful use of deep brain stimulation (DBS) in
      movement disorders, and its promising results in major depressive disorder (MDD), has led
      researchers to consider its use in highly selected refractory cases of BD. Evidence form the
      imaging and circuitry literature suggests that similar underlying dysfunctional anatomic
      structures subserve both MDD and BD, indicating that modulation of key structures, can lead
      to an amelioration of symptoms and mood stabilization.

      Our primary objective is to establish the safety of deep brain stimulation in a patient
      population with treatment refractory bipolar disorder.
    

Intervention name(s): Deep Brain Stimulation
Intervention type(s): Procedure
Intervention description(s): Deep Brain Stimulation (DBS) is a neurosurgical procedure involving the implantation of deep brain electrodes, connected via a subcutaneous extension wire, to an implantable pulse generator (IPG, or 'battery') that is implanted below the collarbone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment