Clnical Trials for Essential Tremor

Quick links:  


Phase III Pivotal Trial

A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects (NCT01827904 – Clinical Trials.gov Identifier)

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).

Primary Outcome Measures:

  • Severity of Device and Procedure related complications
  • 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
  • Effectiveness of the ExAblate Transcranial MRgFUS treatment of medication-refractory Essential Tremor (ET) will be determined using the Clinical Rating Scale for Tremor (CRST)


Download the patient pamphlet about this trial.

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

Download the patient pamphlet about this trial


Contacts and Locations

USA
Swedish Medical Center
Seattle, WA
Principal Investigator: Ryder Gwinn, MD
Contact: Amanda Brown
Phone: 206-320-3070
email: Focusedultrasound@swedish.org   

Stanford Medical Center, CA
Principal Investigator: Pejman Ghanouni, MD
Contact: Ricardo Valenzuela
Phone: 650-725-6930
email: tremorstudy@stanford.edu

University of Maryland School of Medicine and University of Maryland Medical Systems
22S Greene Street, Baltimore, MD 21201
PrincipaI Investigator: Howard Eisenberg, MD
Contact: Andrea Reddick / Paul Fishman MD
Phone: 410-328-4723

University of Virginia
Charlottesville, Virginia, United States, 22908
Principal Investigator: William Jeff Elias, MD
Contact: Johanna J Loomba
Phone: 434-243-1435
email: FUSbrain@virginia.edu


Canada
Sunnybrook Medical Centre, Toronto in conjunction with University of Toronto
Principal Investigators: Michael Schwartz, MD, Neurosurgeon, Department of Surgery
Andres Lozano, MD, Dept. of Neurosurgery, University of Toronto
Study coordinator: Nir Lipsman, MD
email: nir.lipsman@utoronto.ca
Contact: Maheleth Llinas  
Phone: 416-480-6100    
email: Maheleth.Llinas@uhnresearch.ca

Korea
Yonsei University College of Medicine
Principal Investigator: Jin Woo Chang, MD, Ph.D., Professor & Chairman
Department of Neurosurgery, Director, Brain Research Institute
Contact: Eun Jung Kweon, RN. MSN, Stereotactic & Functional Neurosurgery Coordinator
Phone: 82-2-2227-4578  (Mobile: 82-17-282-1044)
Fax: 82-2-393-9979
email: kweonej@yuhs.ac
Website: http://www.iseverance.com

Japan
Shin-Yurigaoka General Hospital, Kanagawa, Japan
Principal Investigator: Prof. Takaomi Taira
Director of Stereotactic and Functional Neurosurgery
Tokyo Women’s Medical University
Contact: Prof. Taira
Phone: 81-3-3353-8111  
email: ttaira@nij.twmu.ac.jp

 

Clnical Trials for Essential Tremor
Related Videos
This text will be replaced
This text will be replaced