Trial ID or NCT#

NCT01827904

Status

NOT RECRUITING

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).

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 22 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Pejman Ghanouni, MD, PhD
Radiologist
Assistant Professor of Radiology (General Radiology) and, by courtesy, of Neurosurgery and of Urology at the Stanford University Medical Center
Casey H. Halpern, MD
Functional neurosurgeon
Assistant Professor of Neurosurgery and, by courtesy, of Neurology and of Psychiatry and Behavioral Sciences at the Stanford University Medical Center