ExAblate Treatment of Medication Refractory Obsessive Compulsive Disorder
Condition: Medication-refractory Obsessive Compulsive Disorder (OCD)
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The goal of this prospective, non-randomized, single-arm, single site, feasibility study is
      to develop and collect data to evaluate the safety and initial effectiveness of this
      treatment using this ExAblate transcranial System in the treatment of Medication-Refractory
      OCD.
    

Detailed description: 
      The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided
      focused ultrasound thermal ablation of a designated area in the brain of patients suffering
      from medication-refractory OCD, using the ExAblate transcranial system.

      The ExAblate system is a medical device that involves a focused ultrasound system and an MRI
      scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the
      targeted tissue. For OCD Patients: one or more thermal lesion will be created on one of the
      following targets: Anterior cingulate cortex, Anterior Limb of internal Capsule, Ventral
      Striatum or Subgenual Cingulate Cortex.

      The treatment begins with a series of standard diagnostic MR images to identify the location
      and shape of tumor to be treated. The ExAblate computer uses the physician's designation of
      the target volume to plan the best way to cover the target volume with small spots called
      "sonications". These treatment spots are cylinder shaped. Their size depends on sonication
      power and duration. During the treatment, a specific MR scan, which can be processed to
      identify changes in tissue temperature, provides a thermal map of the treatment volume to
      confirm the therapeutic effect. The thermal map is used to monitor the treatment in progress,
      and confirm that the ablation is proceeding according to plan, thus closing the therapy loop.

      The ExAblate transcranial operates a helmet-shaped transducer (currently utilizing
      1000-element phased array transducer) positioned above the subject head. The ExAblate
      transcranial system also includes means to immobilize the subject head, cool the interface
      water, and software for CT analysis and phase correction computation.

      After informed consent and screening, eligible subjects will proceed to the treatment. All
      subjects will be followed at Day 1, 7 days, 1 month, 6 months and 1, 2 and 3 years. At follow
      up visits, patients will be evaluated for general health, neurological changes (including
      MMSE exam),and efficacy measurements as well as for device/procedure related adverse events
      that may have occurred during the follow-up period. Six (6) month and 1, 2 and 3 year follow
      up visits will also include Full Battery Cognitive/Neurological Testing.
    

Intervention name(s): ExAblate Transcranial MRgFUS System
Intervention type(s): Device
Intervention description(s): Treatment with the ExAblate Transcranial MRgFUS System.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment