NCT02246374

ExAblate Transcranial MRgFUS of the Subthalamic Nucleus for Treatment of Parkinson's Disease

A Randomized Feasibility Clinical Trial of the Management of the Medically-Refractory Motor Symptoms of Advanced Idiopathic Parkinson's Disease With Unilateral Lesioning of the Subthalamic Nucleus Using the ExAblate Transcranial System

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: InSightec · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

This is primarily a safety protocol to evaluate the safety of subthalamotomy using Transcranial ExAblate for treatment of Parkinson's Disease (PD) motor features.

Detailed description

This study is designed as a prospective, randomized, double-blind (to subjects and examiners), two-arm (ExAblate treated arm vs ExAblate Sham treated control arm) feasibility study. All treated subjects will be followed for 12 months. Data will be collected to establish the basic safety and clinical efficacy of this type of treatment as the basis for later studies that will evaluate the full clinical efficacy.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DEVICE	ExAblate Transcranial System	ExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease

Timeline

• Start date: 2014-09-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2014-09-22
• Last updated: 2025-05-01

Locations

1 site across 1 country: United States