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Clinical Trials in Canada / NCT02252380
Active, not recruiting Not applicable

ExAblate Transcranial MRgFUS for the Management of Treatment-Refractory Movement Disorders

NCT02252380 · tracked via the Priya Life Science Canada tracker
Sponsor
Phase
Not applicable
Started
2015-05
Last updated
2025-05-01

Condition(s) studied

Movement DisordersEssential TremorHolmes TremorParkinson's DiseaseWilson's DiseaseHuntington's DiseaseDystoniaTardive DyskinesiaOrofacial Dyskinesias

Investigational drug(s) / intervention(s)

Transcranial ExAblate System

Transcranial ExAblate System: MR Guided Focused Ultrasound

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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: * Unstable angina pectoris on medication * Patients with documented myocardial infarction within six months of protocol entry * Congestive heart failure requiring medication (other than diuretic) * Patients on anti-arrhythmic drugs * 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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Sunnybrook Health Sciences Centre Toronto Ontario
Toronto Western Hospital Toronto Ontario

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02252380 on ClinicalTrials.gov ↗ ← All trials in Canada