CompletedNot Applicable

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

South Korea4 participantsStarted 2015-08-27

Plain-language summary

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

Who can participate

Age range

20 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women, between 20 and 65 years, inclusive * Diagnosed with nonpsychotic major depressive disorder, single or recurrent episode by DSM-IV-TR Diagnosis of Diagnostic and Statistical Manual of Mental Disorder fourth edition(DSM-IV) MDD as confirmed from clinical history and examination by psychiatrist. * Subjects who are able and willing to give consent and able to attend all study visits * Proof of Refractoriness In current episode: * Depression refractory to adequate trials of medication (Persistence of the major depressive episode to a minimum of 3 adequate depression treatments from at least 3 different treatment categories - SSRIs, TCAs, other antidepressants, lithium addition, irreversible MAO inhibitor, etc.) * Documented resistance to ECT (at least 6 sessions or \<6 treatments if there is clear evidence of inability to tolerate more, or refused, or withdrew consent after ECT was recommended. \- Proof of chronicity * More than 5 years after first episode of MDD * current episode of ≥24-mo duration \&/or recurrent illness with at least a total of 4 lifetime episodes (including current episode ≥12 mos) \- Proof of Severity * HAMD-17 score≥20 * Global Assessment of Function Score\<50 * Designated Ablation Targets can be target by the ExAblate device. Designated Ablation Targets must be apparent on MRI such that targeting can be performed with direct visualization * Able to communicate sensations during the ExAblate MRgFUS treatment…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess Hamilton Depression Rating Scale-17

Timeframe: 6 months

Trial details

NCT IDNCT02348411

SponsorYonsei University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07-23

View on ClinicalTrials.gov More Major Depressive Diorder trials