Essential TremorNCT06974916
EMBRACE Tremor BiFUS
A study testing Staged bilateral Exablate thalamotomy and Local standard medical treatment after previous Exablate unilateral thalamotomy. in people with Essential Tremor, run by InSightec at 13 sites in 7 countries.
Trial summary
This is a post-market (Phase IV) randomized, controlled, blinded, multicenter study with the aim to determine the added value of staged bilateral Exablate thalamotomy compared to a group of patients on previous unilateral treatment combined with local standard medical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Staged bilateral Exablate thalamotomy and Local standard medical treatment after previous Exablate unilateral thalamotomy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 13 sitesin 7 countries
- Study dates
- 22 Apr 2025to Mar 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with an age of 18 years or older (according to local labeling).
- Willing to participate in the study (i.e., signed ICF). (Willing to be randomized).
- Patient is able to undergo a high-resolution Computerized Tomography (CT) scan.
- Patient is able to fit into MRI unit and comply with all contraindications for the specific magnetic resonance (MR) system including and limited to contrast medium should there be needed.
- The thalamus, sub-thalamus and the pallidum must be apparent on MR imaging.
- Patient is able to communicate sensations to the physician during the procedure; Procedure does not require general anesthesia.
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- Patient must be able to use the Stop Sonication button freely.
- Patient willing to have their head shaved prior to the actual treatment.
- Patient has no history for claustrophobia which is not responding to medications.
- ET patients who are eligible for second side staged bilateral Exablate thalamotomy treatment (according to local labeling). Time since first intervention is at least 9 months.
- Available tremor assessment prior to the unilateral Exablate thalamotomy.
- Patients randomized to the study, irrespective of group allocation should be willing and able to remain in the study for at least 6 months and able to complete the required assessments.
Who cannot join
- Subject experienced any non-transient neurological event or worsening following the previous Exablate procedure.
- Patients with MRI related contraindications (e.g. presence of metallic implants incompatibility with MRI, severe claustrophobia, reaction to contrast medium).
- Patients in whom it is not possible to avoid energy absorbing structures or sensitive tissues (e.g., skull implants, surgical clips, shunts, electrodes, dura patch, skull patch, electrodes, etc.) from the path of the ultrasound beam.
- Patients with concurrent active infections disease and/or severe allergies with fever.
- Patients that have been diagnosed with brain tumors or a vascular anomaly.
- Patients with a history of seizures, brain hemorrhages, stroke within the past year, or any coagulopathy.
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- Patients under anticoagulants and/or anti-platelets drugs known to increase bleeding risk within the duration defined by the half-life of the specific drugs.
- Patient that has been given any contrast agent (e.g., CT, MRI), within 24 hours before treatment
- Severe unstable hypertension that cannot be controlled by medications (diastolic Blood Pressure > 100 on medication).
- Patients with unstable cardiac status.
- Patients exhibiting any behavior(s) consistent with ethanol or substance abuse.
- Cerebrovascular disease (multiple CVA or CVA within 6 months).
- Patients with risk factors for intraoperative or postoperative bleeding.
- Imaging shows abnormal finding in CT or/and MRI (e.g., brain tumor, brain vascular malformation, shunt, etc.).
- Patient has physical subscale score ≥ 16.5 on the Dysphagia Handicap Index or has been diagnosed with dysphagia.
- Patient with cognitive impairment.
- Patient with clinically significant abnormal speech function as determined by a speech pathologist.
Trial locations and contacts
13 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
Insightec contact
13 sites in 7 countries
Spain4 sites, 3 recruiting
- Recruiting
Germans Trias i Pujol Hospital
Badalona, 08916
Dolores Vilas Rolán, dvilas.germanstrias@gencat.cat
- Recruiting
HM CINAC- Hospital Universitario HM Puerta del Sur
Móstoles, 28938
Raul Martinez Fernandez, rmartinez.hmcinac@hmhospitales.com
- Recruiting
Clinica Universidad de Navarra
Pamplona, 31008
Maria Cruz Rodriguez Oroz, mcroroz@unav.es
- Active, not recruiting
Ascires Hospital_ECG Salud
Valencia, 46014
Japan3 sites, 3 recruiting
- Not yet recruiting
Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-Kofukai
Kita-ku, Osaka
Hiroki Toda, +81 6-6312-1221, hi-toda@kitano-hp.or.jp
Hiroki Toda
- Not yet recruiting
Central Japan International Medical Center
Minokamo, Gifu
Daisuke Nakatsubo, +81 574 66 1100, nakatsubo.daisuke@cjimc-hp.jp
Daisuke Nakatsubo
- Not yet recruiting
Kashiwaba Neurology Hospital
Sapporo, Hokkaido
Takuhito Narita, +81 11-598-6080, takuhoito_n68@yahoo.co.jp
Takuhito Narita
Taiwan2 sites, 2 recruiting
- Recruiting
Chang Bing Show Chwan Memorial Hospital
Changhua, 500
Pei-Han Wu, +886 975 617 083, ain0418@hotmail.com
Pei-Han Wu
- Not yet recruiting
National Taiwan University Hospital
Taipei, 100225
Yung-Tsai Chu, +886-2-2312-3456, chuyungtsai@gmail.com
Yung-Tsai Chu
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku, FI20520
Valtteri Kaasinen, valtteri.kaasinen@tyks.fi
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH)
Kiel, 24105
Steffen Paschen, steffen.paschen@uksh.de
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, 20133
Roberto Eleopra, roberto.eleopra@istituto-besta.it
United Kingdom1 site, 1 recruiting
- Not yet recruiting
The Walton Center
Liverpool, L97LJ
Jibril Farah, jibril.farah1@nhs.net
About this study
Official title: International, Multicenter, Investigator Blinded, Randomized And Controlled Essential Tremor Trial With Staged-Bilateral FUS
This is a post-market (Phase IV) randomized, controlled, blinded, multicenter study with the aim to determine the added value of staged bilateral Exablate thalamotomy compared to a group of patients on previous unilateral treatment combined with local standard medical treatment.
Read the detailed description
In patients who have undergone previous unilateral Exablate thalamotomy for Essential Tremor, the aim of this trial is to determine the effect of staged bilateral Exablate thalamotomy compared to a group of patients on previous unilateral treatment. The effect will be measured on tremor reduction, functional impairment, disease-specific quality of life, adverse events and patient-perception of the overall treatment result in patients eligible for a staged bilateral Exablate procedure.
Patients assigned to the treatment arm will receive staged bilateral Exablate thalamotomy. Patients assigned to control group will remain under local standard medical treatment.
The primary efficacy study objective is to demonstrate that Exablate staged-bilateral thalamotomy treatment reduces tremor, as measured by Treated Upper Limb CRST (A+B) (0-28) score, to a higher extent than those remaining on previous unilateral Exablate thalamotomy at 6 months.
The primary safety study objective is to assess the adverse events (AEs) of Exablate staged-bilateral thalamotomy treatment in comparison to those remaining on unilateral treatment (control group) plus medical treatment, including AE type, incidence, severity and duration at 6 months.
- Conditions
- Essential Tremor
- Being tested
- Staged bilateral Exablate thalamotomy, Local standard medical treatment after previous Exablate unilateral thalamotomy.
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staged bilateral Exablate thalamotomyProcedure or surgery
Staged bilateral Exablate thalamotomy in ET patients
Local standard medical treatment after previous Exablate unilateral thalamotomy.Other
Local standard medical treatment
| Study group | Role | What they receive |
|---|---|---|
| Exablate Arm | Experimental | Subjects will receive staged bilateral Exablate thalamotomy. Receives: Procedure: Staged bilateral Exablate thalamotomy |
| Control Arm | Active comparator | Subjects will continue with their standard of care treatment for 6 months. Receives: Other: Local standard medical treatment after previous Exablate unilateral thalamotomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treated Upper Limb Clinical Rating Scale for Tremor (CRST) (A+B) (0-28) score for the treated side.
The primary endpoint is the difference of the Treated Upper Limb CRST (A+B) score between groups at 6 months. Higher score means a worse tremor.
Measured: 6 Months
Secondary outcomes (9)
Treated Upper Limb Clinical Rating Scale for Tremor (CRST) (A+B) (0-28) score as assessed by the blinded reviewers of the video-recordings.
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Treated Upper Limb CRST (A+B) score as assessed by the blinded reviewers of the video-recordings. Higher score means a worse tremor.
Measured: 6 Months, 12 Months
Clinical Rating Scale for Tremor (CRST) part A (0-76)
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in resting, postural, and action tremors of all items as measured by CRST part A. Higher score means a worse tremor.
Measured: 6 Months, 12 Months
Bilateral Upper Limb Clinical Rating Scale for Tremor (CRST) (A+B) (0-56)
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Bilateral Upper Limb CRST (A+B). Higher score means a worse tremor.
Measured: 6 Months, 12 Months
Total Clinical Rating Scale for Tremor (CRST) (A+B) (0-116)
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Total CRST (A+B). Higher score means a worse tremor.
Measured: 6 Months, 12 Months
Clinical Rating Scale for Tremor (CRST) part C (0-32)
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in functional disabilities as measured by CRST part C. Higher score means a worse tremor.
Measured: 6 Months, 12 Months
Axial Clinical Rating Scale for Tremor (CRST) (0-20)
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Axial CRST defined as face, tongue, head tremor and voice items of CRST part A
Measured: 6 Months, 12 Months
Quality of life questionnaire
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in disease specific QOL
Measured: 6 Months, 12 Months
Change of tremor medication
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in tremor medication change
Measured: 6 Months, 12 Months
Safety: Incidence and frequency of adverse events related to the treatment.
Incidence and frequency of adverse events related to the treatment and/or procedure. The investigator will capture any untoward events in the case report forms along with severity, duration, and resolution, and whether the event is considered serious. The severity of adverse events will be categorized according to the definition of adverse events from the International Organization for Standardization (ISO).
Measured: 6 Months, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start22 Apr 2025
- Primary completionJul 2027 (estimated)
- Study completionMar 2028 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Günther Deuschl, Principal investigator, Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH)Steffen Paschen, Principal investigator, Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974916
- Sponsor's protocol ID
- ET006
- Status last verified
- Aug 2026
- First submitted
- 7 May 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multicenter, Investigator Blinded, Randomized And Controlled Essential Tremor Trial With Staged-Bilateral FUS
- ClinicalTrials.gov ID
- NCT06974916
- Acronym / sponsor ID
- ET006
- Conditions
- Essential Tremor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 16 May 2025 (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.
This is a post-market (Phase IV) randomized, controlled, blinded, multicenter study with the aim to determine the added value of staged bilateral Exablate thalamotomy compared to a group of patients on previous unilateral treatment combined with local standard medical treatment.
Detailed description
In patients who have undergone previous unilateral Exablate thalamotomy for Essential Tremor, the aim of this trial is to determine the effect of staged bilateral Exablate thalamotomy compared to a group of patients on previous unilateral treatment. The effect will be measured on tremor reduction, functional impairment, disease-specific quality of life, adverse events and patient-perception of the overall treatment result in patients eligible for a staged bilateral Exablate procedure.
Patients assigned to the treatment arm will receive staged bilateral Exablate thalamotomy. Patients assigned to control group will remain under local standard medical treatment.
The primary efficacy study objective is to demonstrate that Exablate staged-bilateral thalamotomy treatment reduces tremor, as measured by Treated Upper Limb CRST (A+B) (0-28) score, to a higher extent than those remaining on previous unilateral Exablate thalamotomy at 6 months.
The primary safety study objective is to assess the adverse events (AEs) of Exablate staged-bilateral thalamotomy treatment in comparison to those remaining on unilateral treatment (control group) plus medical treatment, including AE type, incidence, severity and duration at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exablate Arm | Experimental | Procedure: Staged bilateral Exablate thalamotomySubjects will receive staged bilateral Exablate thalamotomy. |
| Control Arm | Active comparator | Other: Local standard medical treatment after previous Exablate unilateral thalamotomy.Subjects will continue with their standard of care treatment for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men and women with an age of 18 years or older (according to local labeling).
- Willing to participate in the study (i.e., signed ICF). (Willing to be randomized).
- Patient is able to undergo a high-resolution Computerized Tomography (CT) scan.
- Patient is able to fit into MRI unit and comply with all contraindications for the specific magnetic resonance (MR) system including and limited to contrast medium should there be needed.
- The thalamus, sub-thalamus and the pallidum must be apparent on MR imaging.
Key exclusion criteria (17 listed)
- Subject experienced any non-transient neurological event or worsening following the previous Exablate procedure.
- Patients with MRI related contraindications (e.g. presence of metallic implants incompatibility with MRI, severe claustrophobia, reaction to contrast medium).
- Patients in whom it is not possible to avoid energy absorbing structures or sensitive tissues (e.g., skull implants, surgical clips, shunts, electrodes, dura patch, skull patch, electrodes, etc.) from the path of the ultrasound beam.
- Patients with concurrent active infections disease and/or severe allergies with fever.
- Patients that have been diagnosed with brain tumors or a vascular anomaly.
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 |
|---|---|---|
| Staged bilateral Exablate thalamotomyStaged bilateral Exablate thalamotomy in ET patients | Procedure or surgery | Exablate Arm |
| Local standard medical treatment after previous Exablate unilateral thalamotomy.Local standard medical treatment | Other | Control Arm |
Primary outcome
Treated Upper Limb Clinical Rating Scale for Tremor (CRST) (A+B) (0-28) score for the treated side.
Time frame: 6 Months
The primary endpoint is the difference of the Treated Upper Limb CRST (A+B) score between groups at 6 months. Higher score means a worse tremor.
9 secondary outcomes
Treated Upper Limb Clinical Rating Scale for Tremor (CRST) (A+B) (0-28) score as assessed by the blinded reviewers of the video-recordings.
Time frame: 6 Months, 12 Months
Clinical Rating Scale for Tremor (CRST) part A (0-76)
Time frame: 6 Months, 12 Months
Bilateral Upper Limb Clinical Rating Scale for Tremor (CRST) (A+B) (0-56)
Time frame: 6 Months, 12 Months
Total Clinical Rating Scale for Tremor (CRST) (A+B) (0-116)
Time frame: 6 Months, 12 Months
Clinical Rating Scale for Tremor (CRST) part C (0-32)
Time frame: 6 Months, 12 Months
Axial Clinical Rating Scale for Tremor (CRST) (0-20)
Time frame: 6 Months, 12 Months
Quality of life questionnaire
Time frame: 6 Months, 12 Months
Change of tremor medication
Time frame: 6 Months, 12 Months
Safety: Incidence and frequency of adverse events related to the treatment.
Time frame: 6 Months, 12 Months
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 31 Aug 2026.
- 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.
Insightec contact
Günther Deuschl principal investigator
Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH)
Steffen Paschen principal investigator
Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH)
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staged bilateral Exablate thalamotomy and Local standard medical treatment after previous Exablate unilateral thalamotomy. in people with Essential Tremor, run by InSightec at 13 sites in 7 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 12 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain, Japan, Taiwan, Finland, Germany and 2 more countries. 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?
Contact Pascalle Reiters (+31 653726776, pascaller@insightec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treated Upper Limb Clinical Rating Scale for Tremor (CRST) (A+B) (0-28) score for the treated side. (time frame: 6 Months). 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 31 Aug 2026.