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Movement disorders trials

Assessment of Safety and Feasibility of Exablate Neuro system to perform Echo-Focusing Echo Imaging in Patients with Treatment-Resistant Neurologic and Psychiatric Indications

Magnetic resonance-guided focused ultrasound (MRgFUS) can be used to perform ablative neurosurgical procedures, mitigating the risks of open cranial approaches. To date, MRgFUS approved, for the treatment of patients with refractory essential tremor, and there is a growing experience in refractory psychiatric illnesses. The ability to generate a lesion, depends primarily on the patient’s skull density. In this study, we use a new technique called Echo-focusing to enhance efficiency of ultrasound transmission through the skull and be able to treat those who would otherwise be ineligible for a lesioning procedure.

The objective of the proposed study is to evaluate the safety and effectiveness of Echo-Focusing using Exablate Neuro as a tool for treating patients with treatment-refractory neurologic and psychiatric disorders: refractory essential tremor, major depressive disorder (MDD), obsessive compulsive disorder (OCD), post-traumatic stress disorder (PTSD) (with comorbid MDD or OCD), and anorexia nervosa (with comorbid MDD or OCD). We believe that this will be safer than and as effective as open neurosurgery, while mitigating the risks of open cranial approaches.

A total of 46 subjects will be enrolled. Safety will be determined by an evaluation of the incidence and severity of procedure-related complications from the treatment day visit through the 12-month post–treatment time point.

For more information or to inquire about eligibility for the trial, please email harquailcentre@sunnybrook.ca. Please indicate in the subject line your diagnosis and which study you are inquiring about.

A Safety Pilot Clinical Trial of a Second Magnetic Resonance Guided Focused Ultrasound (MRgFUS) Thalamotomy for the Management of Severe Hand Tremor in Patients with Medication-Refractory Essential Tremor

Patients who are medication-refractory for essential tremor (ET) often require a surgical option to relieve symptoms of ET and improve quality of life. To-date, unilateral magnetic resonance-guided focused ultrasound (MRgFUS) has been beneficial in providing patients with some of relief from tremor. However, tasks that require two hands remain a challenge for many patients. Historical risks of bilateral treatment have been an impediment to complete tremor relief. The introduction of MRI and current stereotactic methodologies has significantly reduced the probability of non-target tissue injury. In this study, a second MRgFUS thalamotomy will be performed in a cohort of patients who have already successfully undergone unilateral MRgFUS treatment. It will be an open-label, 12-week pilot trial, and it will assess the safety and preliminary efficacy of a second MRgFUS thalamotomy on the naïve brain hemisphere after 48 weeks or more of the first MRgFUS thalamotomy in patients with medication-refractory ET. Tremor severity, speech, balance, gait, and cognition will be assessed during baseline and follow up visits.

For more information or to inquire about eligibility for the trial, please email harquailcentre@sunnybrook.ca. Please indicate in the subject line your diagnosis and which study you are inquiring about.