NCT03454425

A Study to Evaluate the Safety and Efficacy of ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features

A Prospective, Randomized, Sham Controlled Study to Evaluate the Safety and Efficacy of ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: InSightec · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to test the efficacy and safety of unilateral subthalamotomy performed using the ExAblate System for the treatment of Parkinson's disease (PD) motor features.

Detailed description

A Prospective, Randomized, Sham Controlled Study to Evaluate the Safety and Efficacy of ExAblate Subthalomotomy for the treatment of Parkinson's disease motor features. The objective of this prospective, randomized, double-blind (to subjects, examining neurologists and external video-based examination by Movement Disorders neurologist), two-arm study (ExAblate treated arm Vs ExAblate Sham treated control arm) is to confirm the efficacy of ExAblate Model 4000 Type 1 System for the treatment of Parkinson's disease (PD) motor features and to further demonstrate safety.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Exablate Subthalamotomy	ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features
DEVICE	Sham Exablate Subthalamotomy	Sham ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features

Timeline

• Start date: 2018-02-27
• Primary completion: 2020-06-15
• Completion: 2020-06-15
• First posted: 2018-03-05
• Last updated: 2026-03-24

Locations

1 site across 1 country: Spain