Medication-refractory Obsessive Compulsive Disorder (OCD) Clinical Trial
Official title:
A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound Treatment of Medication-Refractory OCD
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.
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.
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