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

Not Recruiting

Trial ID: NCT01827904


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).

Official Title

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

Stanford Investigator(s)

Pejman Ghanouni, MD, PhD
Pejman Ghanouni, MD, PhD

Associate Professor of Radiology (General Radiology) and, by courtesy, of Neurosurgery, of Obstetrics and Gynecology and of Urology


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

   - 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


device: Transcranial ExAblate

device: Sham Transcranial ExAblate

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jennifer Lillian Marcellus