Essential TremorNCT04112381
Bilateral Treatment of Medication Refractory Essential Tremor
A study testing Exablate Model 4000 Type 1.0/1.1 in people with Essential Tremor, run by InSightec at 7 sites in United States.
Trial summary
The purpose of this study is to see if the MR-guided focused ultrasound (MRgFUS) thalamotomy procedure can be performed on both sides of the brain safely and effectively to reduce bilateral tremor. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Exablate Model 4000 Type 1.0/1.1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Jun 2020to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women age 22 years or older
- Diagnosis of medication-refractory Essential Tremor
- Has previously underwent an Exablate index procedure in a clinical trial or in a commercial setting at least 9 months prior to enrolling in this trial
- Able to communicate sensations during the Exablate thalamotomy procedure
Who cannot join
- Has experienced any non-transient neurological event or worsening following the Exablate index procedure
- Presence of unknown or MR unsafe devices anywhere in the body
- Non-transient hemiparesis as determined by physical examination
- Clinically significant abnormal speech function as determined by a speech pathologist
- Pregnant or breastfeeding
- Unstable cardiac status
Show all 16Show fewer
- Behavior(s) consistent with ethanol or substance abuse
- History of bleeding disorder
- Has received anticoagulants within one month of Exablate procedure
- Cerebrovascular disease
- Intracranial tumor
- Active or suspected acute or chronic uncontrolled infection
- Has previously had deep brain stimulation or a prior stereotactic ablation of the basal ganglia or thalamus
- Implanted objects in the skull or the brain
- Currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research
- Unable to communicate with the investigator and staff
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Maryland
Baltimore, Maryland, 21201
University of Virginia
Charlottesville, Virginia, 22908
The Ohio State University - Wexner Medical Center
Columbus, Ohio, 43210
West Virginia University
Morgantown, West Virginia, 26505
Weill Cornell Medicine
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
Stanford University, School of Medicine
Stanford, California, 94305
About this study
Official title: A Pivotal Clinical Trial to Evaluate the Safety and Efficacy of Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
The purpose of this study is to see if the MR-guided focused ultrasound (MRgFUS) thalamotomy procedure can be performed on both sides of the brain safely and effectively to reduce bilateral tremor.
- Conditions
- Essential Tremor
- Being tested
- Exablate Model 4000 Type 1.0/1.1
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exablate Model 4000 Type 1.0/1.1Device
Exablate thalamotomy of non tremor dominant side of the brain
| Study group | Role | What they receive |
|---|---|---|
| Exablate Secondary Procedure | Experimental | Thalamotomy Receives: Device: Exablate Model 4000 Type 1.0/1.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device and procedure related adverse events
rate of adverse events following the Exablate secondary procedure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start30 Jun 2020
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential TremorStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112381
- Sponsor's protocol ID
- ET005
- Status last verified
- Apr 2025
- First submitted
- 30 Sep 2019
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kaplitt MG, Krishna V, Eisenberg HM, Elias WJ, Ghanouni P, Baltuch GH, Rezai A, Halpern CH, Dalm B, Fishman PS, Buch VP, Moosa S, Sarva H, Murray AM. Safety and Efficacy of Staged, Bilateral Focused Ultrasound Thalamotomy in Essential Tremor: An Open-Label Clinical Trial. JAMA Neurol. 2024 Sep 1;81(9):939-946. doi: 10.1001/jamaneurol.2024.2295.
PubMed 39073822
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Clinical Trial to Evaluate the Safety and Efficacy of Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
- ClinicalTrials.gov ID
- NCT04112381
- Acronym / sponsor ID
- ET005
- Conditions
- Essential Tremor
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 2 Oct 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 purpose of this study is to see if the MR-guided focused ultrasound (MRgFUS) thalamotomy procedure can be performed on both sides of the brain safely and effectively to reduce bilateral tremor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exablate Secondary Procedure | Experimental | Device: Exablate Model 4000 Type 1.0/1.1Thalamotomy |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women age 22 years or older
- Diagnosis of medication-refractory Essential Tremor
- Has previously underwent an Exablate index procedure in a clinical trial or in a commercial setting at least 9 months prior to enrolling in this trial
- Able to communicate sensations during the Exablate thalamotomy procedure
Key exclusion criteria (16 listed)
- Has experienced any non-transient neurological event or worsening following the Exablate index procedure
- Presence of unknown or MR unsafe devices anywhere in the body
- Non-transient hemiparesis as determined by physical examination
- Clinically significant abnormal speech function as determined by a speech pathologist
- Pregnant or breastfeeding
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 |
|---|---|---|
| Exablate Model 4000 Type 1.0/1.1Exablate thalamotomy of non tremor dominant side of the brain | Device | Exablate Secondary Procedure |
Primary outcome
Device and procedure related adverse events
Time frame: 3 months
rate of adverse events following the Exablate secondary procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Derived from this study: PubMed 39073822Kaplitt MG, Krishna V, Eisenberg HM, Elias WJ, Ghanouni P, Baltuch GH, Rezai A, Halpern CH, Dalm B, Fishman PS, Buch VP, Moosa S, Sarva H, Murray AM. Safety and Efficacy of Staged, Bilateral Focused Ultrasound Thalamotomy in Essential Tremor: An Open-Label Clinical Trial. JAMA Neurol. 2024 Sep 1;81(9):939-946. doi: 10.1001/jamaneurol.2024.2295.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exablate Model 4000 Type 1.0/1.1 in people with Essential Tremor, run by InSightec at 7 sites in United States.
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 4 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Device and procedure related adverse events (time frame: 3 months). 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 NCT04112381, which also lists 1 linked publication.
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 1 May 2025.