An interventional study of Staged bilateral Exablate thalamotomy and Local standard medical treatment after previous Exablate unilateral thalamotomy. in Essential Tremor, sponsored by InSightec. Recruiting at 13 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by InSightec · Not applicable, Interventional, and Treatment
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.
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.
272 studies on the registry are indexed under Essential Tremor; 75 are open to participants now.
This study's planned enrollment of 100 is above the median of 25 across 189 interventional studies indexed under Essential Tremor.
Browse Essential Tremor studies →InSightec is the lead sponsor of 84 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive staged bilateral Exablate thalamotomy.
Procedure: Staged bilateral Exablate thalamotomy
Subjects will continue with their standard of care treatment for 6 months.
Other: Local standard medical treatment after previous Exablate unilateral thalamotomy.
Staged bilateral Exablate thalamotomy in ET patients
Local standard medical treatment
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.
Time frame: 6 Months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 6 Months, 12 Months
Objective assessment of specific adverse events
Objective assessment of specific adverse events will be carried out for Speech, Gait and Motor Strength at baseline and 6 months and eventually at 12 months. If the adverse reported in the objective assessment is resolved at 6 months (Speech, Gait and Motor strength) it will not be carried out for the 12-month visit.
Time frame: 6 Months, 12 Months
Patient Global Impression of Change (PGIC)
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Patient Global Impression of Change (PGIC). PGIC is a 7-point scale depicting a patient's rating of overall improvement. Higher score means a worse condition.
Time frame: 6 Months, 12 Months
Clinician Global Impression of Change (CGIC)
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Clinician Global Impression of Change (CGIC). The CGIC comprises two companion one-item measures evaluating the following: (a) severity of pathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale. Higher score means a worse condition.
Time frame: 6 Months, 12 Months
Caregiver Global Impression of Change (CaGIC)
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Caregiver Global Impression of Change (CaGIC). The CaGIC comprises two companion one-item measures evaluating the following: (a) severity of pathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale. Higher score means a worse condition.
Time frame: 6 Months, 12 Months
Beck Depression Inventory II
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Beck Depression Inventory II (BDI-II). The Beck Depression Inventory is a 21-question multiple-choice self-report inventory and is composed of items relating to symptoms of depression.
Time frame: 6 Months, 12 Months
Montreal Cognitive Assessment (MoCA)
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in MoCA Score. The MoCA is a validated assessment that is used to detect cognitive impairment.
Time frame: 6 Months, 12 Months
Responder analysis
A responder analysis will be performed to compute the proportion of subjects achieving a clinically satisfactory result. The CRST will be used. The responder analysis will be based on this scoring: * Full responder: no tremor (0) or barely no tremor (1). * Partial responder: moderate tremor, \< 2cm, (2) * Insufficient responder: marked (2-4 cm, 3) or severe (\> 4 cm)
Time frame: 6 Months
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Jul 2027, 27 months after the start.
Of 95 interventional studies with no phase under Essential Tremor, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 93. This study's planned 27 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.