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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by InSightec
Sponsor:
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT01827904
First received: March 27, 2013
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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 Intervention
Essential Tremor
Device: Transcranial ExAblate
Device: Sham Transcranial ExAblate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by InSightec:

Primary Outcome Measures:
  • Severity of Device and Procedure related complications [ Time Frame: At the time of ExAblate Transcranial thalamotomy procedure ] [ Designated as safety issue: Yes ]
    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:
  • Effectiveness of of the ExAblate Transcranial MRgFUS treatment [ Time Frame: participants will be followed from the date of treatment until study completion, approximately up to 12 months ] [ Designated as safety issue: No ]
    Effectiveness of the ExAblate Transcranial MRgFUS treatment of medication-refractory Essential Tremor (ET) will be determined using the Clinical Rating Scale for Tremor (CRST)


Estimated Enrollment: 72
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Sham Transcranial ExAblate

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.

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01827904

Locations
United States, California
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Ricardo Valenzuela    650-725-6930    tremorstudy@stanford.edu   
Principal Investigator: Pejman Ghanouni, M.D.         
United States, Maryland
University of Maryland Medical System Recruiting
Baltimore, Maryland, United States, 21201
Contact: Andrea Reddick    410-328-4723      
Principal Investigator: Howard Eisenberg, MD         
Sub-Investigator: Paul Fishman, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Wesley Field    617-732-6858    ETremor@partners.org   
Principal Investigator: Travis Tierney, MD, PhD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Johanna J Loomba    434-243-1435    FUSbrain@virginia.edu   
Principal Investigator: William Jeff Elias, MD         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Amanda Brown    206-320-3070    Focusedultrasound@swedish.org   
Principal Investigator: Ryder Gwinn, M.D.         
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Maheleth Llinas    416-603-5800 ext 6121    Maheleth.Llinas@uhnresearch.ca   
Principal Investigator: Michael Schwartz, M.D.         
Japan
Tokyo Women's Medical University (TWMU) Recruiting
Tokyo, Japan, 162-8666
Contact: Takaomi Taira, Prof    +81 3-3353-8111    ttaira@nij.twmu.ac.jp   
Principal Investigator: Takaomi Taira, M.D., Ph.D.         
Korea, Republic of
Yonsei University Medical Center Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Eun Jung Kweon, RN    82-2-2227-4578    kweonej@yuhs.ac   
Principal Investigator: Jin Woo Chang, MD         
Sponsors and Collaborators
InSightec
  More Information

No publications provided

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT01827904     History of Changes
Other Study ID Numbers: ET002
Study First Received: March 27, 2013
Last Updated: July 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by InSightec:
ExAblate Transcranial MRgFUS

Additional relevant MeSH terms:
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014