Essential TremorNCT03465761
Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
A study testing ExAblate in people with Essential Tremor, run by InSightec at 2 sites in 2 countries.
Trial summary
The objective of this prospective, multi-site, single-arm, open-label study is to capture the safety and efficacy (outcome) of bilateral staged Exablate treatment in subjects with bilateral medication-refractory essential tremor (ET). Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Essential 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
- 7 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Jan 2019to 17 Nov 2025
- 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
- Subjects who:
- previously underwent Exablate thalamotomy for their essential tremor in a clinical study or in a commercial procedure at least 9 months prior to enrolling in this study for contralateral Exablate thalamotomy
- Subjects who would benefit from a bilateral treatment for their essential tremor and would want to undergo a staged bilateral thalamotomy
- All subjects must have a complete baseline CRST prior from first Exablate thalamotomy
- Men and women age 22 years to 75 years of age.
- Minimum score of 24 on MoCA or 20 on MMSE
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- Subjects who are able and willing to give consent and able to attend all study visits
- Postural or intention tremor severity score of greater than or equal to 2 in the both upper extremities as measured by the CRST rating scale while on stable medication
- Thalamus can be targeted by the Exablate device. The region must be apparent on MRI such that targeting can be performed.
- Able to communicate sensations during the Exablate Thalamotomy treatment
- Original (before first Exablate procedure) CRST score of 2 or above in any one of the items 16-23 from the Disability subsection of the CRST: speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities.
- Subjects on antidepressant medications must be stable for at least 3 months prior to procedure(i.e., no change in medication drug or dosage for 3 months based on historical medical records).
- Remains eligible for Exablate treatment with no changes to medical history that would affect Exablate treatment criteria, (e.g., bleeding/coagulation requirements, or new pathology such as infarct, tumor, etc).
Who cannot join
- Subjects with unstable cardiac status
- Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the following occurring within a 12 month period:
- Subjects with uncontrollable blood pressure (hypertensive with diastolic BP > 100 on medication)
- History of abnormal bleeding and/or coagulopathy, i.e. subjects with risk factors for intraoperative or postoperative bleeding as indicated by: platelet count less than 100,000 per cubic millimeter, a documented clinical coagulopathy, or INR coagulation studies exceeding the institution's laboratory standard
- Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure
- Active or suspected acute or chronic uncontrolled infection
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- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time.)
- Subjects with life-threatening systemic disease that include but not limited to the following will be excluded from the study participation: HIV, Liver Failure, blood dyscrasias, etc...
- Any clinically significant moderate to severe sensory deficit lasting greater than 30 days after the first Exablate thalamotomy NOTE: Subjects with clinically significant moderate to severe sensory deficit following first Exablate thalamatomy should be excluded even if event resolves within a few months of treatment. This may cause new first thalamotomy subjects to be ineligible for the bilaterally staged treatment.
- Moderate to severe cerebellar disturbance (imbalance or ataxia) or presence of moderate or severe hemiparesis NOTE: Subjects with moderate to severe cerebellar disturbance (imbalance or ataxia) or presence of moderate or severe hemiparesis following first Exablate thalamatomy should be excluded even if event resolves within a few months of treatment. This may cause new first thalamotomy subjects to be ineligible for the bilaterally staged treatment.
- Any persistent dysphasia/dysarthria, language impairment following first Exablate thalamotomy.
- NOTE: Subjects with significant impairment following first Exablate thalamotomy should be excluded even if event resolves within a few months of treatment. This may cause new first thalamotomy subjects to be ineligible for the bilaterally staged treatment.
- Significant reduction in cognitive function since the first thalamotomy. NOTE: Subjects with significant reduction in cognitive function following first Exablate thalamatomy should also be excluded even if event resolves within a few months of treatment. This may cause new first thalamotomy subjects to be not eligible for the bilaterally staged treatment.
- Subject is pregnant or breastfeeding.
- Subjects who have an overall Skull Density Ratio of less than 0.40 as calculated at screening
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Clinical Trial to Evaluate the Safety and Efficacy of Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
The objective of this prospective, multi-site, single-arm, open-label study is to capture the safety and efficacy (outcome) of bilateral staged Exablate treatment in subjects with bilateral medication-refractory essential tremor (ET). The staged second procedure will be performed at least 9 months after the first side. The benefit of real-time feedback will allow the physician to maximize benefit without jeopardizing safety.
This study is designed as a prospective, open-label, single arm, multi-site study design.
- Conditions
- Essential Tremor
- Being tested
- ExAblate
- Keywords
- MRgFUS, ExAblate, Bilateral Essential Tremor
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblateDevice
Bilateral side treatment of Essential Tremor
| Study group | Role | What they receive |
|---|---|---|
| ExAblate 4000 System | Experimental | ExAblate treatment of Bilateral Essential Tremor Receives: Device: ExAblate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Rating Scale for Tremor (CRST)
The CRST is a standard tremor rating scale which measures subjects' tremor (Part A), motor Function (Part B), and Activities of Daily Living (Part C). Scores range from 0-4 with 0 being no tremor.
Measured: Baseline through Month 12 after First and Second Treatment
Incidence of Device and Procedure related Adverse Events
All AEs will be reported and categorized by investigators in relation to the device or procedure, disease or unrelated to the device or procedures and categorized by first or second Exablate thalamotomy.
Measured: Treatment through Month 12 after Second Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start3 Jan 2019
- Primary completion7 Dec 2021
- Study completion17 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465761
- Sponsor's protocol ID
- ET003
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2018
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Safety and Efficacy of Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
- ClinicalTrials.gov ID
- NCT03465761
- Acronym / sponsor ID
- ET003
- Conditions
- Essential Tremor
- Keywords
- MRgFUS, ExAblate, Bilateral Essential Tremor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 14 Mar 2018 (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 prospective, multi-site, single-arm, open-label study is to capture the safety and efficacy (outcome) of bilateral staged Exablate treatment in subjects with bilateral medication-refractory essential tremor (ET). The staged second procedure will be performed at least 9 months after the first side. The benefit of real-time feedback will allow the physician to maximize benefit without jeopardizing safety.
This study is designed as a prospective, open-label, single arm, multi-site study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExAblate 4000 System | Experimental | Device: ExAblateExAblate treatment of Bilateral Essential Tremor |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects who:
- All subjects must have a complete baseline CRST prior from first Exablate thalamotomy
- Men and women age 22 years to 75 years of age.
- Minimum score of 24 on MoCA or 20 on MMSE
- Subjects who are able and willing to give consent and able to attend all study visits
Key exclusion criteria (15 listed)
- Subjects with unstable cardiac status
- Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the following occurring within a 12 month period:
- Subjects with uncontrollable blood pressure (hypertensive with diastolic BP > 100 on medication)
- History of abnormal bleeding and/or coagulopathy, i.e. subjects with risk factors for intraoperative or postoperative bleeding as indicated by: platelet count less than 100,000 per cubic millimeter, a documented clinical coagulopathy, or INR coagulation studies exceeding the institution's laboratory standard
- Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure
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 |
|---|---|---|
| ExAblateBilateral side treatment of Essential Tremor | Device | ExAblate 4000 System |
Primary outcome
Clinical Rating Scale for Tremor (CRST)
Time frame: Baseline through Month 12 after First and Second Treatment
The CRST is a standard tremor rating scale which measures subjects' tremor (Part A), motor Function (Part B), and Activities of Daily Living (Part C). Scores range from 0-4 with 0 being no tremor.
Incidence of Device and Procedure related Adverse Events
Time frame: Treatment through Month 12 after Second Treatment
All AEs will be reported and categorized by investigators in relation to the device or procedure, disease or unrelated to the device or procedures and categorized by first or second Exablate thalamotomy.
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 20 Mar 2026.
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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.
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 Essential Tremor, 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 13 inclusion and 15 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 20 Mar 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 Spain, United Kingdom. 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?
Clinical Rating Scale for Tremor (CRST) (time frame: Baseline through Month 12 after First and Second Treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2026.