Electrical Stimulation of the Internal Capsule for Intractable Obsessive-compulsive Disorder (OCD)
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and effectiveness of deep brain stimulation in treating
      people with severe and otherwise treatment-resistant obsessive-compulsive disorder. We also
      expect to determine how DBS affects brain activity in brain circuits strongly implicated in
      OCD, and how such effects may relate to symptom change. This treatment study therefore also
      permits a unique and crucial test of current neuroanatomical models of both OCD pathogenesis
      and mechanisms underlying the response to treatment.
    

Detailed description: 
      Obsessive-compulsive disorder (OCD) is a chronic and debilitating illness that affects
      between 2% and 3% of the adult population of the United States. People with OCD often
      experience persistent unwanted thoughts and carry out ritual-like behaviors to rid themselves
      of these obsessive thoughts. Additionally, OCD symptoms are usually tied with feelings of
      intense anxiety and functional impairment, making it important for people with OCD to seek
      effective treatment. Although there are currently many treatment options for OCD, including
      psychotherapy and medications such as serotonin reuptake inhibitors, between 40% and 60%of
      people with OCD only partially respond, or do not respond at all, to these treatment methods.
      Given the large percentage of people who do not respond to aggressive conventional
      treatments, alternative options are necessary for people with treatment-resistant OCD. Deep
      brain stimulation (DBS) is a procedure that involves the se of thin wires to carry electric
      current to parts of the brain associated with producing OCD symptoms. DBS has been
      effectively and safely used to treat movement disorders, such as Parkinson's disease, and may
      be beneficial in reducing OCD symptom severity. This study will evaluate the safety and
      efficacy of DBS in treating people with severe and treatment-resistant OCD.

      Study participation through follow-up will last up to 2 years. Participants will be allowed
      to remain on any pre-surgical medications or behavioral therapy programs throughout the
      study. Before surgery, all participants will undergo a series of initial tests and
      examinations that will include psychiatric, medical, and neuropsychological histories and
      examinations.

      Implantation of the devices will be performed at a single session. The leads that are
      inserted into the anterior limb of each internal capsule, will be implanted under local
      anesthesia. On the day of the surgery, participants will have a metal frame fixed to their
      heads for support during surgery, and magnetic resonance imagining (MRI) will be used to
      determine the exact placement of the wires. An extension wire will pass from the scalp area
      to the subclavicular region and connect each electrode to a subcutaneous implanted pulse
      generator (IPG), which will be implanted under general anesthesia. After placement of the DBS
      system, the patient will be admitted to the hospital for overnight observation for possible
      complications. Postoperative evaluation will consist of physical and neurological
      examinations, postoperative CBC, electrolyte panel, x-rays of the head, neck, and chest, a
      standard shunt series to ensure the integrity of connections, and a head CT scan to monitor
      for possible postoperative intracranial hemorrhage.

      Surgical implantation will be followed by a three-week period with no stimulation, and then
      an intensive five-day preliminary outpatient stimulation trial, followed by longer-term
      outpatient stimulation. All patients will follow the same sequence of test conditions. The
      initial DBS testing will be open, followed by three blocks of testing in which the patients
      and investigators administering rating scales will not be informed of the stimulation
      condition. These three blocks will in general be three months long, but may be longer or
      shorter depending on the stability of any clinical improvement, and the possible emergence of
      symptom worsening. The remainder of the the study, up to the two-year study endpoint, will
      consist of a continuation phase of active open stimulation.
    

Intervention name(s): Medtronic Activa Deep Brain Stimulation
Intervention type(s): Device
Intervention description(s): In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant.
Other intervention name(s): Deep Brain Stimulation (DBS); Activa System; Medtronic Activa Deep Brain Stimulation Therapy System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Deep brain stimulation; Treatment refractory; Ventral internal capsule/ventral striatum; Neurosurgery; Neuroimaging