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Clinical Trial Summary

The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.


Clinical Trial Description

This is a post-approval registry which is required by of the approval under PMA P150038/S006 for the Exablate® Model 4000 (Exablate Neuro) Type 1.0 and Type 1.1 for unilateral thalamotomy in the treatment of medication refractory Tremor Dominant Parkinson's Disease (TDPD). Subjects participating in this registry will have received a unilateral thalamotomy (ventralis medius) prior to enrollment using the commercially available Exablate Neuro for the treatment of Essential tremor and TDPD. The following assessments will be collected at Baseline,1, 3, 6, and 12 months post Exablate procedure and annually thereafter for 5 years: - Adverse Events (AEs) (does not apply to Baseline Visit) - Medication usage - Clinical Rating Scale for Tremor (CRST) ON medication - Unified Parkinson's Disease Rating Scale Part III ON medication - EQ-5D-5L - WPAI-GH ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04991831
Study type Observational
Source InSightec
Contact Mark Grassman, Ph.D.
Phone 214-630-2000
Email markg@insightec.com
Status Recruiting
Phase
Start date April 28, 2022
Completion date December 2027