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TerminatedNCT03253991Updated Apr 20, 2023

A Study to Evaluate the Effectiveness and Safety of ExAblate MRgFUS on Essential Tremor

An interventional study of MRgFUS treatment in Essential Tremor, sponsored by InSightec. Terminated at 11 sites in 3 countries. Open to participants aged 22 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-04-20.

Sponsored by InSightec · Not applicable, Interventional, and Treatment

Why this study was terminated
Sponsor decision

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Nov 2014, registered Jul 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
154
Allocation
Not applicable
Ages
22 Years to 99 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 13 studies in Essential Tremor by InSightec — 1 open to participants now, 4 under way, none of them phase 3. Essential Tremor · InSightec.

Enrollment
Largest of 12
154 · median 18
Started
2014
the only one that year
No phase
10 of 13
1 open now
Registered
8th of 13
by date

Among the 13 studies in Essential Tremor by InSightec, this one has the largest enrollment of the 12 interventional ones that give a count, is the only one that started in 2014, is one of 10 with no phase, and was the 8th registered.

Essential Tremor

272 studies on the registry are indexed under Essential Tremor; 75 are open to participants now.

Browse Essential Tremor studies →

Open to participants now

1 of the 13 studies in Essential Tremor by InSightec is open now, in 7 countries. Recruiting first, the newest first:

By country, each count listing its studies:

Finland1
Germany1
Italy1
Japan1
Spain1
Taiwan1
United Kingdom1

Who these studies take

Of the 61 Essential Tremor studies recruiting now, 32 (52%) set no upper age limit and 5 (8%) stop at 75 or younger; 8 take children under 18; 7 take healthy volunteers.

This study: 22 Years to 99 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies in Essential Tremor by InSightec, or all of them as a file.
02

Study summary

A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects

The objective of this prospective, single-arm study is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor inpatients with essential tremor (ET).

The Indications for Use claim for this system is as follows: Treatment of medication-refractory tremor in patients with essential tremor.

Read the detailed description

The objective of this prospective, multi-site, single-arm study is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in subjects with essential tremor (ET).

Safety: To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial MRgFUS treatment of medication-refractory ET Effectiveness: To determine the effectiveness of the ExAblate Transcranial MRgFUS treatment of medication-refractory tremor (i.e. ET). Efficacy will be determined utilizing the Clinical Rating Scale for Tremor (CRST) in ET from examinations at baseline and 3-Months post-ExAblate treatment.

  • This study is designed as a prospective, multi-site, single-arm study. Assessments of primary efficacy endpoints will compare the three months after ExAblate treatment to Baseline measurements for clinical symptom relief. Safety of ExAblate in the treatment of ET will be collected for one year after ExAblate treatment. Relative Safety will be evaluated using a common description of Significant Clinical Complications for patients treated in this study. This study will be performed on the 3T MR scanners.

The secondary endpoints of the study are as follows:

  1. Quality life claims: Questionnaire for Essential Tremor (QUEST) outcome (upper extremity questions) at Months 3 change from Baseline
  2. Durability (as measured by QUEST upper arm extremity questions) of the procedure as reflected by the efficacy data through change from baseline measures through Month 12 follow up
  3. Subject daily functionalities: as measured by CRST Part-C (subscales)Month 12 as compared to Baseline.
03

Conditions studied

  • Essential Tremor

Browse trials for

04

Who can participate

Ages eligible
22 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Men and women age 22 years or older
  • A diagnosis of ET as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder
  • Have had an inadequate response to one or two oral doses of medication, per local standards. An inadequate medication trial is defined as a therapeutic dose of each medication and poor response to drug, or the development of side effects as the medication dose is titrated.
  • Able to communicate sensations during the ExAblate TcMRgFUS treatment

Exclusion criteria

Exclusion criteria:

  • Subjects with unstable cardiac status
  • Severe hypertension (diastolic BP > 100 on medication)
  • Subjects with standard for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
  • Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
  • Patient with severely impaired renal function
  • History of abnormal bleeding and/or coagulopathy
  • History of immunocompromise including those who are positive.
  • History of intracranial hemorrhage
  • Cerebrovascular disease (multiple CVA or CVA within 6 months)
  • Subjects with uncontrolled symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, papilledema).
  • 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.)
  • Are participating or have participated in another clinical trial in the last 30 days
  • Significant claustrophobia that cannot be managed with mild medication.
  • Presence of any other neurodegenerative disease such as Parkinson-plus syndromes suspected on neurological examination.
  • Presence of significant cognitive impairment
  • Subjects with life-threatening systemic disease
  • Subjects with a history of seizures within the past year
  • Subjects with presence or history of psychosis
Terms in these criteria, in plain language(2)

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.

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.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
154 participants (actual)

Study arms

  • Experimental
    MRgFUS treatment

    MRgFUS device treatment, thalamotomy

    Device: MRgFUS treatment

Interventions

  • DeviceMRgFUS treatment

    ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects

    Also known as: Thalamotomy

06

What researchers measure

Primary outcomes

  1. Safety - Will be determined evaluating incidence and severity of device related complications from first treatment day visit through all follow ups. Relative Safety will be evaluated describing Significant Clinical Complications for patients treated.

    All AEs will be reported and categorized by investigators as definitely, probably, possibly, or unrelated to the device or procedure and categorized by treatment group / treatment arm. Relative Safety will be evaluated using a common description of Significant Clinical Complications for patients treated in this study.

    Time frame: 1 year

  2. Effectiveness - Will be evaluated using the Clinical Rating Scale for Tremors (CRST) for ET subjects. Comparison will be performed from examinations at baseline and 3-Months post-ExAblate treatment.

    Assessments of efficacy endpoints will compare the three months after ExAblate treatment to Baseline measurements for clinical symptom relief.

    Time frame: 5 Years

07

Study locations

11 sites
  • Chinese PLA General Hospital
    Beijing, Beijing 100853, China
  • Henan Provincial People's Hospital
    Zhengzhou, Henan 450003, China
  • Sadamoto Hospital
    Ehime, 790-0052, Japan
  • Shonan Fujisawa Tokushukai Hospital
    Fujisawa, 2510041, Japan
  • Hokkaido Ohno Memorial Hospital
    Hokkaido, 063-0052, Japan
  • Hokuto
    Hokkaido, 080-0833, Japan
  • Ohanishi Noerological Center
    Hyōgo, 6740064, Japan
  • Kumagaya General Hospital
    Kumagaya, 360-8567, Japan
  • Department of Neurosurgery, Osaka University Hospital
    Osaka, 565-0871, Japan
  • Tokyo Women's Medical University Hospital
    Tokyo, 62-8666, Japan
  • Chang Bing Show Chwan Memorial Hospital
    Chang Hua, 505, Taiwan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2014 to primary completion in Feb 2023, 98 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2017
First posted
Aug 18, 2017
StartActual
Nov 17, 2014
Primary completionActual
Feb 2, 2023
CompletionActual
Feb 2, 2023
Last update
Apr 20, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03253991
Lead sponsor
InSightec
Responsible party
Sponsor
First posted
Aug 18, 2017
Start date
Nov 17, 2014
Primary completion
Feb 2, 2023
Completion
Feb 2, 2023
Last update
Apr 20, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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