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ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01827904
Recruitment Status : Active, not recruiting
First Posted : April 10, 2013
Last Update Posted : March 31, 2022
Information provided by (Responsible Party):

Brief Summary:
The objective of this prospective, randomized, double-blind (to subjects, local site's blinded assessor and Tremor Core Lab assessors), crossover, multi-site, two-arm study (ExAblate treated arm Vs ExAblate Sham treated control arm) 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).

Condition or disease Intervention/treatment Phase
Essential Tremor Device: Transcranial ExAblate Device: Sham Transcranial ExAblate Not Applicable

Detailed Description:
This study is evaluating a new technique for performing Thalamotomy for tremor control. While current techniques have possible invasive or radiation effects, the use of ExAblate if totally non-invasive and without any radiation. After informed consent and screening, eligible subjects will be randomized to either an ExAblate treatment or an ExAblate Sham or "fake" procedure. The chance of randomization to Sham is one out of four. Subjects who are randomized to Sham Control will undergo the same procedure and follow-up visits through their Month 3 visit. After the Month 3 assessments are complete, all subjects will be unblinded and those in the Sham treated group will have the option for an actual ExAblate treatment in an unblinded fashion, as long as they still qualify for ExAblate treatment. All subjects will be followed at 6 and 12 months and for up to 5 years as directed by their doctor.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
Study Start Date : May 2013
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Transcranial ExAblate
Transcranial ExAblate
Device: Transcranial ExAblate
Other Names:
  • ExAblate
  • TcMRgFUS
  • Thalamotomy

Sham Comparator: Sham Transcranial ExAblate
Sham Treatment with Transcranial ExAblate
Device: Sham Transcranial ExAblate

Primary Outcome Measures :
  1. Primary Efficacy Outcome [ Time Frame: Participants will be followed from the date of treatment until study completion, approximately up to 12 months ]
    The treated upper limb CRST subscore (CRST A + B) applicable to upper limb in the ExAblate Group will be statistically better than the Sham control Group at Month 3

  2. Severity of Device and Procedure related complications [ Time Frame: At the time of ExAblate Transcranial thalamotomy procedure ]
    To evaluate the incidence and severity of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory Essential Tremor related to the ExAblate treatment

Secondary Outcome Measures :
  1. Clinical Rating Scale for Tremor Part C Score [ Time Frame: Participants will be followed from the date of treatment until study completion, approximately up to 12 months ]
    1. Subject daily functionalities: as measured by CRST Part-C (subscales) Month 12 as compared to Baseline, and between treatment groups through Month 3
    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. Quality life claims: Questionnaire for Essential Tremor (QUEST) outcome (upper extremity questions) at Months 3 change from Baseline.as compared between treatment groups

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women, age 22 years and older
  • Subjects who are able and willing to give informed consent and able to attend all study visits
  • Subjects with a diagnosis of Essential Tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder
  • Subject exhibits a significant disability from their ET despite medical treatment
  • Subjects should be on a stable dose of all ET medications for 30 days prior to study entry
  • Subject is able to communicate sensations during the ExAblate Transcranial procedure

Exclusion Criteria:

  • Subjects with unstable cardiac status
  • Severe hypertension
  • Subjects with standard contraindications 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 including advanced kidney disease or severely impaired renal function
  • Significant claustrophobia that cannot be managed with mild medication
  • Current medical condition resulting in abnormal bleeding and/or coagulopathy
  • 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
  • History of intracranial hemorrhage
  • History of multiple strokes, or a stroke within past 6 months
  • Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment
  • Are participating or have participated in another clinical trial in the last 30 days
  • Subjects unable to communicate with the investigator and staff
  • Subjects with a history of seizures within the past year
  • Subjects with brain tumors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827904

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United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Maryland
University of Maryland Medical System
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Tokyo Women's Medical University (TWMU)
Tokyo, Japan, 162-8666
Korea, Republic of
Yonsei University Medical Center
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT01827904    
Other Study ID Numbers: ET002
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: August 2021
Keywords provided by InSightec:
ExAblate Transcranial MRgFUS
Additional relevant MeSH terms:
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Essential Tremor
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases