NCT04991831

A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: InSightec · Industry
• Sex: All
• Age: 30 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Tremor Associated With Tremor Dominant Parkinson's Disease

Interventions

Type	Name	Description
DEVICE	Unilateral thalamotomy	Unilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease.

Timeline

• Start date: 2022-04-28
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2021-08-05
• Last updated: 2026-03-20

Locations

8 sites across 2 countries: United States, United Kingdom