NCT02263885

ExAblate Transcranial MRgFUS of the Globus Pallidum for Treatment of Parkinson's Disease

A Feasibility Clinical Trial of the Management of the Medically-Refractory Dyskinesia Symptoms of Advanced Idiopathic Parkinson's Disease With Unilateral Lesioning of the Globus Pallidum Using the ExAblate Transcranial System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: InSightec · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The proposed study will evaluate the safety, and initial efficacy of using the ExAblate Transcranial to create a unilateral lesion in the globus pallidus as an adjunct to PD medications in subjects who are over 30 years of age and considered medication-refractory with advanced idiopathic Parkinson's disease (PD).

Detailed description

The purpose of this study is to evaluate the safety and initial clinical effectiveness of ExAblate Transcranial unilateral thermal ablation of the globus pallidus of subjects suffering from medication-refractory, advanced idiopathic PD. 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	Transcranial MRgFUS

Timeline

• Start date: 2015-04-01
• Primary completion: 2019-05-15
• Completion: 2019-07-26
• First posted: 2014-10-13
• Last updated: 2022-01-19
• Results posted: 2022-01-19

Locations

5 sites across 1 country: United States