At a glance
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A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease.
In Brief
A clinical study evaluating ExAblate Transcranial MRgFUS and Sham ExAblate Transcranial MRgFUS for Parkinson's Disease. Completed, enrolled 27 participants across 2 sites.
Detailed Summary
This is a feasibility study to evaluate the safety and initial effectiveness of unilateral ExAblate thermal ablation of the Vim thalamic nucleus of subjects suffering from medication-refractory, idiopathic, tremor-dominant PD, using the ExAblate Transcranial system compared to a Sham Vim thalamotomy procedure. Data will be collected to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy. The Sham treatment data will be used to evaluate placebo effect from treatment.
Study Details
Timeline
Interventions
ExAblate Transcranial MR Guided Focused Ultrasound
Sham ExAblate Transcranial MR Guided Focused Ultrasound