ExAblate Transcranial MRgFUS for the Management of Treatment-Refractory Movement Disorders
A Feasibility Clinical Trial of the Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for the Management of Treatment-Refractory Movement Disorders
1 other identifier
interventional
10
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2015
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2014
CompletedFirst Posted
Study publicly available on registry
September 30, 2014
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
May 1, 2025
April 1, 2025
11.1 years
September 26, 2014
April 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Severity of Device and Procedure Related Complications
Safety will be evaluated individually for each subject who is treated
At the time of ExAblate procedure
Study Arms (1)
Transcranial ExAblate System
EXPERIMENTALTranscranial ExAblate System (MRgFUS)
Interventions
MR Guided Focused Ultrasound
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InSighteclead
Study Sites (2)
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Related Publications (4)
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.
PMID: 37722831DERIVEDYamamoto 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.
PMID: 35995551DERIVEDKapadia 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.
PMID: 32651242DERIVEDFasano 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.
PMID: 28747452DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andres Lozano, MD
Sunnybrook Health Sciences Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2014
First Posted
September 30, 2014
Study Start
May 1, 2015
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
May 1, 2025
Record last verified: 2025-04