NCT04002596

Safety and Initial Effectiveness of Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: InSightec · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

Safety and Effectiveness in ExAblate Neuro treatment of medication-refractory tremor in subjects with idiopathic Parkinson's disease.

Detailed description

The goal of this prospective, single-arm, multi-site, feasibility study is to develop data to evaluate the safety and effectiveness of unilateral focused ultrasound thalamotomy using this ExAblate Transcranial System in the treatment of medication-refractory tremor resulting from idiopathic Parkinson's disease. The Indications for Use claim for this system is: treatment of medication-refractory tremor in subjects with idiopathic Parkinson's disease.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	ExAblate Neuro Thalamotomy Treatment	Non-invasive Focused Ultrasound Ablation of Thalamus Vim nucleus using ExAblate MRgFUS system for treatment Tremor Dominant Parkinson Disease

Timeline

• Start date: 2017-02-06
• Primary completion: 2018-12-05
• Completion: 2019-09-04
• First posted: 2019-06-28
• Last updated: 2025-12-31

Locations

1 site across 1 country: Japan