ExAblate Transcranial MRgFUS for the Management of Treatment-Refractory Movement Disorders
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|ClinicalTrials.gov Identifier: NCT02252380|
Recruitment Status : Active, not recruiting
First Posted : September 30, 2014
Last Update Posted : January 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Movement Disorders Essential Tremor Holmes Tremor Parkinson's Disease Wilson's Disease Huntington's Disease Dystonia Tardive Dyskinesia Orofacial Dyskinesias||Device: Transcranial ExAblate System||Not Applicable|
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:
- FUS under MRI-guidance and MRI-based thermometry can be safely delivered to patients suffering from treatment-refractory movement disorders through an intact human skull with a low risk of transient adverse effects as evaluated during follow-up of up to 12-months.
- A pre-defined target volume inside the brain can be accurately ablated, as demonstrated on post-treatment MRI.
- Lesions generated with ExAblate Neuro will result in clinical effects that are similar to those seen with ablative procedures using other surgical techniques (e.g. RF procedure).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Clinical Trial of the Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for the Management of Treatment-Refractory Movement Disorders|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Transcranial ExAblate System
Transcranial ExAblate System (MRgFUS)
Device: Transcranial ExAblate System
MR Guided Focused Ultrasound
- Severity of Device and Procedure Related Complications [ Time Frame: At the time of ExAblate procedure ]Safety will be evaluated individually for each subject who is treated
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252380
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Toronto Western Hospital|
|Toronto, Ontario, Canada, M5T 2S8|
|Principal Investigator:||Andres Lozano, MD||Sunnybrook Health Sciences Centre|