- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03935581
Safety and Feasibility of ExAblate Neuro System to Perform Auto-Focusing Echo Imaging in Patients With Essential Tremor (ET004)
September 15, 2021 updated by: InSightec
Assessment of Safety and Feasibility of ExAblate Neuro System to Perform Auto-Focusing Echo Imaging in Patients With Idiopathic Essential Tremor With Medication Refractory Tremor
The objective of this study is to evaluate the safety and feasibility of Auto Focusing (AF) echo imaging using the ExAblate Neuro system
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This clinical investigation is a feasibility study designed to evaluate the safety and feasibility of the ExAblate Neuro system to perform AF echo imaging in patients diagnosed with idiopathic Essential Tremor.
during the standard care procedure for ET, patients will be injected with Definity microbubbles which will enable the ExAblate Neuro system to perform the AF imaging.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook
-
-
-
-
Seodaemun-gu
-
Seoul, Seodaemun-gu, Korea, Republic of, 03722
- Yonsei University Health System, Severance Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or Female age 22 years or older
- Able and willing to give consent and able to attend all study visits
- A confirmed diagnosis of Essential Tremor resistant to medication therapy
- Able to fit into MRI unit
- Able to tolerate the procedure with or without some form of sedation
- Able to communicate sensations during the ExAblate MRgFUS procedure
- Able to activate Stop Sonication button during the ExAblate MRgFUS procedure
Exclusion Criteria:
- Presence of unknown or MRI unsafe devices anywhere in the body.
- Patients with known intolerance or allergies to the MRI contrast agents
- Women who are pregnant
- Patients with advanced kidney disease or on dialysis
- Significant cardiac disease or unstable hemodynamic status
- Patients exhibiting any behavior(s) consistent with ethanol or substance abuse
- History of a bleeding disorder
- Patients receiving anticoagulant or drugs known to increase risk of hemorrhage
- Patients with cerebrovascular disease
- Patients with brain tumors
- Individuals who are not able or unwilling to tolerate the required prolonged stationary position during treatment (approximately 2-3 hours)
- Patients who are currently participating in another clinical investigation
- Patients unable to communicate with the investigator and staff
- Patients who have cardiac shunts
- Patients with relative contraindications to Definity ultrasound contrast agent including subjects with a family or personal history of arrhythmia's
- Patients with chronic pulmonary disorders
- Patients with a history of drug allergies, uncontrolled asthma or hay fever
- Patients who have had deep brain stimulation or a prior neuroablative procedure
- Women who are pregnant or nursing
- Patients who have been administered botulinum toxins into the arm, neck, or face for 5 months prior to enrollment in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ExAblate 4000 System
ExAblate Neuro system to perform AF echo imaging in treatment of Essential Tremor
|
Auto Focusing (AF) echo imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of Device and Procedure related Adverse Events
Time Frame: Treatment through 1 month
|
Treatment through 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nir Lipsman, Sunnybrook Health Science Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chang KW, Rachmilevitch I, Chang WS, Jung HH, Zadicario E, Prus O, Chang JW. Safety and Efficacy of Magnetic Resonance-Guided Focused Ultrasound Surgery With Autofocusing Echo Imaging. Front Neurosci. 2021 Jan 12;14:592763. doi: 10.3389/fnins.2020.592763. eCollection 2020.
- Jones RM, Huang Y, Meng Y, Scantlebury N, Schwartz ML, Lipsman N, Hynynen K. Echo-Focusing in Transcranial Focused Ultrasound Thalamotomy for Essential Tremor: A Feasibility Study. Mov Disord. 2020 Dec;35(12):2327-2333. doi: 10.1002/mds.28226. Epub 2020 Aug 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 25, 2019
Primary Completion (Actual)
December 31, 2020
Study Completion (Anticipated)
December 30, 2021
Study Registration Dates
First Submitted
April 18, 2019
First Submitted That Met QC Criteria
May 1, 2019
First Posted (Actual)
May 2, 2019
Study Record Updates
Last Update Posted (Actual)
September 17, 2021
Last Update Submitted That Met QC Criteria
September 15, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ET004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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