A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Tremor

Project Name: A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Tremor
Status: Complete
Primary Site: Sunnybrook Health Sciences Centre
Sponsor Organization: INSIGHTEC, Ltd.
Funded Date: Jun 13, 2011
Funding Program: Brain Program
Funding Period: Jun 13, 2011 - Jun 13, 2012
Amount Awarded: $180,000.00
Category: Essential Tremor

Abstract

The proposed study is to evaluate the safety and initial effectiveness of the ExAblate Transcranial MRI-guided focused ultrasound (MRgFUS) treatment of patients with medication-refractory movement disorders, namely Essential Tremor (ET) • Safety: To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial MRgFUS treatment of medication-refractory tremor (i.e.: ET) Effectiveness: To determine the level of effectiveness of the ExAblate Transcranial MRgFUS treatment of medication-refractory tremor (i.e. ET). Efficacy will be determined utilizing the Clinical Rating Scale for Tremor in ET from examinations at baseline and 3-Months post-ExAblate treatment.

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