Tremor, EssentialET004NCT03935581
Safety and Feasibility of ExAblate Neuro System to Perform Auto-Focusing Echo Imaging in Patients With Essential Tremor
A study testing ExAblate in people with Tremor, Essential and Neurologic Manifestations, run by InSightec at 2 sites in 2 countries.
Trial summary
The objective of this study is to evaluate the safety and feasibility of Auto Focusing (AF) echo imaging using the ExAblate Neuro system Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Tremor, Essential, Neurologic Manifestations, Tremor
- What is being tested?
- ExAblate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Apr 2019to 28 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul, Seodaemun-gu, 03722
About this study
Official title: 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
Read the 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.
- Conditions
- Tremor, Essential, Neurologic Manifestations, Tremor
- Being tested
- ExAblate
- Keywords
- MRgFUS, ExAblate, Essential Tremor, Auto-Focusing Echo Imaging
- Medical subject headings
- Essential Tremor, Neurologic Manifestations, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblateDevice
Auto Focusing (AF) echo imaging
| Study group | Role | What they receive |
|---|---|---|
| ExAblate 4000 System | Experimental | ExAblate Neuro system to perform AF echo imaging in treatment of Essential Tremor Receives: Device: ExAblate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Device and Procedure related Adverse Events
Measured: Treatment through 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start25 Apr 2019
- Primary completion28 Apr 2020
- Study completion28 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tremor, EssentialStudies of the same condition, open and under way.
- More trials run by InSightecThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nir Lipsman, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935581
- Sponsor's protocol ID
- ET004
- Acronym
- ET004
- Status last verified
- Sep 2026
- First submitted
- 18 Apr 2019
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33510610Jones 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.
PubMed 32815611
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03935581
- Acronym / sponsor ID
- ET004 / ET004
- Conditions
- Tremor, Essential, Neurologic Manifestations, Tremor
- Keywords
- MRgFUS, ExAblate, Essential Tremor, Auto-Focusing Echo Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 28 Apr 2020 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and feasibility of Auto Focusing (AF) echo imaging using the ExAblate Neuro system
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExAblate 4000 System | Experimental | Device: ExAblateExAblate Neuro system to perform AF echo imaging in treatment of Essential Tremor |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExAblateAuto Focusing (AF) echo imaging | Device | ExAblate 4000 System |
Primary outcome
Incidence of Device and Procedure related Adverse Events
Time frame: Treatment through 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Derived from this study: PubMed 33510610Chang 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.
- Derived from this study: PubMed 32815611Jones 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nir Lipsman principal investigator
Sunnybrook Health Sciences Centre
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExAblate in people with Tremor, Essential and Neurologic Manifestations, run by InSightec at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Device and Procedure related Adverse Events (time frame: Treatment through 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03935581, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.