A global post approval study to collect safety and effectiveness data related to ExAblate Neuro for the treatment of certain disorders such as Essential Tremor, Parkinson's Movement Disorders, or Neuropathic Pain within the thalamus and/or pallidum.
A global, multi-center, open-label, observational registry to capture safety and effectiveness data related to ExAblate Neuro, an MRI guided focused ultrasound device designed to lesion tissue deep within the brain using sound waves without the need for craniotomy. This registry includes certain regional and country specific approved thalamotomy and pallidotomy procedures using ExAblate Neuro for the treatment of various neurologic disorders such as essential tremor, Parkinson's movement disorders, and neuropathic pain. Treatment targets/indications are country/region dependent based on approved labeling within that region.
Study Type
OBSERVATIONAL
Enrollment
500
Stanford University
Stanford, California, United States
University of Maryland
Baltimore, Maryland, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Virginia
Charlottesville, Virginia, United States
Clinical Rating Scale for Tremor
CRST
Time frame: 5 year
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Swedish Neuroscience Institute
Seattle, Washington, United States
Sunnybrook
Toronto, Ontario, Canada
Rambam Healthcare Campus
Haifa, Israel
Sheba Medical Center
Ramat Gan, Israel
Chang Bing Show Chwan Memorial Hospital
Chang-hua, Taiwan