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The proposed study is to evaluate the effectiveness of ExAblate Transcranial MRgFUS as a tool for creating a unilateral lesion in the Vim thalamus or the globus pallidus (GPi) in patients with treatment-refractory symptoms of movement disorders.
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 movement disorder symptoms:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial ExAblate System | Experimental | Transcranial ExAblate System (MRgFUS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial ExAblate System | Device | MR Guided Focused Ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Device and Procedure Related Complications | Safety will be evaluated individually for each subject who is treated | At the time of ExAblate procedure |
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Inclusion Criteria:
Men and women, between 18 and 85 years, inclusive.
Subjects who are able and willing to give consent and able to attend all study visits.
A movement disorder symptom that has been deemed treatment-refractory by a movement disorder neurologist, including:
o akathisia, akinesia, athetosis, bradykinesia, chorea, dystonia, tremor, myoclonus, dyskinesia, spasms, tics
Medication-refractoriness as determined by an adequate dose and duration of standard movement disorders treatment as determined by a specialist neurologist (e.g. a trial of primidone and propranolol for ET)
Able to communicate sensations during the ExAblate Neuro treatment
Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
Exclusion Criteria:
Patients with unstable cardiac status including:
Severe hypertension (diastolic BP > 100 on medication)
Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
History of abnormal bleeding and/or coagulopathy (including deep venous thrombosis)
Cerebrovascular disease (multiple CVA or CVA within 6 months)
Symptoms and signs of increased intracranial pressure (e.g. headache, nausea, vomiting, lethargy, and papilledema)
Untreated, uncontrolled sleep apnea
Active or suspected acute or chronic uncontrolled infection
History of intracranial hemorrhage
Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment
Are participating or have participated in another clinical trial in the last 30 days
Patients unable to communicate with the investigator and staff.
Presence of any other neurodegenerative disease like multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
Patients with a history of seizures within the past year
Patients with psychiatric illness that are not well controlled. Any presence of psychosis will be excluded.
Patients with risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter) or a documented coagulopathy
Patients with brain tumors
Any illness that in the investigator's opinion preclude participation in this study.
Pregnancy or lactation.
Patient is unable to provide his own consent for any reason.
Legal incapacity or limited legal capacity.
Patients who have DBS or a prior stereotactic ablation of the basal ganglia
History of immunocompromise, including patient who is HIV positive
Known life-threatening systemic disease
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| Name | Affiliation | Role |
|---|---|---|
| Andres Lozano, MD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada | ||
| Toronto Western Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37722831 | Derived | Germann J, Santyr B, Boutet A, Sarica C, Chow CT, Elias GJB, Vetkas A, Yang A, Hodaie M, Fasano A, Kalia SK, Schwartz ML, Lozano AM. Comparative neural correlates of DBS and MRgFUS lesioning for tremor control in essential tremor. J Neurol Neurosurg Psychiatry. 2024 Jan 11;95(2):180-183. doi: 10.1136/jnnp-2022-330795. | |
| 35995551 |
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| Toronto |
| Ontario |
| M5T 2S8 |
| Canada |
| Yamamoto K, Sarica C, Elias GJB, Boutet A, Germann J, Loh A, Joel SE, Bigioni L, Gwun D, Gramer R, Li SX, Zemmar A, Vetkas A, Algarni M, Devenyi G, Chakravarty M, Hynynen K, Scantlebury N, Schwartz ML, Lozano AM, Fasano A. Ipsilateral and axial tremor response to focused ultrasound thalamotomy for essential tremor: clinical outcomes and probabilistic mapping. J Neurol Neurosurg Psychiatry. 2022 Aug 22:jnnp-2021-328459. doi: 10.1136/jnnp-2021-328459. Online ahead of print. |
| 32651242 | Derived | Kapadia AN, Elias GJB, Boutet A, Germann J, Pancholi A, Chu P, Zhong J, Fasano A, Munhoz R, Chow C, Kucharczyk W, Schwartz ML, Hodaie M, Lozano AM. Multimodal MRI for MRgFUS in essential tremor: post-treatment radiological markers of clinical outcome. J Neurol Neurosurg Psychiatry. 2020 Sep;91(9):921-927. doi: 10.1136/jnnp-2020-322745. Epub 2020 Jul 10. |
| 28747452 | Derived | Fasano A, Llinas M, Munhoz RP, Hlasny E, Kucharczyk W, Lozano AM. MRI-guided focused ultrasound thalamotomy in non-ET tremor syndromes. Neurology. 2017 Aug 22;89(8):771-775. doi: 10.1212/WNL.0000000000004268. Epub 2017 Jul 26. |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D020329 | Essential Tremor |
| D001259 | Ataxia |
| D010300 | Parkinson Disease |
| D006527 | Hepatolenticular Degeneration |
| D006816 | Huntington Disease |
| D004421 | Dystonia |
| D000071057 | Tardive Dyskinesia |
| D020820 | Dyskinesias |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008661 | Metabolism, Inborn Errors |
| D008664 | Metal Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003704 | Dementia |
| D002819 | Chorea |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D004409 | Dyskinesia, Drug-Induced |
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