A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Bilateral Anterior Capsulotomy in the Treatment of Medication-Refractory MDD
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|ClinicalTrials.gov Identifier: NCT02348411|
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : February 15, 2019
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 MDD, 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 MDD Patients: one or more thermal lesion will be created on Bilateral Anterior Limb of internal Capsule.
The treatment begins with a series of standard diagnostic MR images to identify the location and shape of target 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 , and 6 months . 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 follow up visit will also include Full Battery Cognitive/Neurological Testing
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Diorder||Device: ExAblate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||August 27, 2015|
|Actual Primary Completion Date :||July 23, 2018|
|Actual Study Completion Date :||July 23, 2018|
|Experimental: ExAblate Treatment group||
Other Name: Treatment with the ExAblate Transcranial MRgFUS System
- To assess Hamilton Depression Rating Scale-17 [ Time Frame: 6 months ]
- To assess adverse events [ Time Frame: 6 months ]
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): NCT02348411
|Korea, Republic of|
|Department of Neurosurgery, Yonsei University College of Medicine|
|Seoul, Korea, Republic of, 120752|