Essential Tremor Clinical Trial
Official title:
Assessment of Safety and Feasibility of Exablate Neuro System to Perform Echo-Focusing Echo Imaging in Patients With Treatment-Resistant Neurologic and Psychiatric Indications
Evaluate the safety and effectiveness of Echo-Focusing using Exablate Neuro as a tool for treating patients with treatment-refractory neurologic and psychiatric disorders.
The objective of the proposed study is to evaluate the safety and effectiveness of Echo-Focusing using Exablate Neuro as a tool for treating patients with treatment-refractory neurologic and psychiatric disorders. Safety will be determined by an evaluation of the incidence and severity of procedure-related complications from the treatment day visit through the 12-month post-treatment time point, although events that are not procedure or device related will be also captured and recorded. Clinical efficacy will be determined using standard clinical metrics, appropriate for the patient's condition. The hypotheses tested include: 1. Exablate ablation with Echo-Focusing can be safely performed in patients suffering from treatment-resistant psychiatric illness and essential tremor. 2. Echo-Focusing will allow for more efficient (faster) treatments, which require less energy (measured in Joules), as compared to published data from Exablate thalamotomy99 and Exablate-capsulotomy100 performed without Echo-Focusing. 3. Lesion appearances following Exablate ablation with Echo-Focusing will be similar in radiographic appearance to those created without Echo-Focusing. 4. Patients who undergo Exablate ablation with Echo-Focusing will demonstrate similar rates of clinical improvement from those seen after non-Echo-Focusing ablation. ;
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