ExAblate Treatment of Medication Refractory Obsessive Compulsive Disorder
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|ClinicalTrials.gov Identifier: NCT01986296|
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : April 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Medication-refractory Obsessive Compulsive Disorder (OCD)||Device: ExAblate Transcranial MRgFUS System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound Treatment of Medication-Refractory OCD|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2019|
|Actual Study Completion Date :||December 2019|
|Experimental: ExAblate Treatment||
Device: ExAblate Transcranial MRgFUS System
Treatment with the ExAblate Transcranial MRgFUS System.
- Effectiveness of the ExAblate Transcranial MRgFUS treatment of medication-refractory OCD [ Time Frame: Participants will be followed from the date of treatment until study completion, up to 36 months ]Effectiveness of the ExAblate Transcranial MR-guided Focused Ultrasound (MRgFUS) treatment of medication-refractory OCD will be determined using the Yale-Brown Obsessive-Compulsive Disorder Scale (Y-BOCS), Hamilton Depression Rating Scale (HAM-D), and Hamilton Anxiety Rating Scale (HAM-A) from examinations at baseline and through 6-Months post-ExAblate treatment.
- Device or procedure related Adverse Events reported [ Time Frame: 36 month ]Safety of the ExAblate transcranial treatment will be determined by an evaluation of the incidence and severity of device and procedure related complications from the first / treatment day visit through the 6-Months post-treatment time point. All Adverse Events (AEs) will be reported and categorized by investigators as definitely, probably, possibly, or unrelated to the device, procedure, or post-surgical changes in neurological status. Alternative treatments resulting from post-surgical changes in neurological status will be reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986296
|Korea, Republic of|
|Yonsei University Medical Center|
|Seoul, Korea, Republic of, 120-752|
|Principal Investigator:||Jin Woo Chang, Prof.||Yonsei University|