NCT02252380

ExAblate Transcranial MRgFUS for the Management of Treatment-Refractory Movement Disorders

A Feasibility Clinical Trial of the Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for the Management of Treatment-Refractory Movement Disorders

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: InSightec · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The proposed study is to evaluate the effectiveness of ExAblate Transcranial MRgFUS as a tool for creating a unilateral lesion in the Vim thalamus or the globus pallidus (GPi) in patients with treatment-refractory symptoms of movement disorders.

Detailed description

The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided focused ultrasound thermal ablation of a designated area in the brain of patients suffering from movement disorder symptoms: * FUS under MRI-guidance and MRI-based thermometry can be safely delivered to patients suffering from treatment-refractory movement disorders through an intact human skull with a low risk of transient adverse effects as evaluated during follow-up of up to 12-months. * A pre-defined target volume inside the brain can be accurately ablated, as demonstrated on post-treatment MRI. * Lesions generated with ExAblate Neuro will result in clinical effects that are similar to those seen with ablative procedures using other surgical techniques (e.g. RF procedure).

Conditions

• Movement Disorders
• Essential Tremor
• Holmes Tremor
• Parkinson's Disease
• Wilson's Disease
• Huntington's Disease
• Dystonia
• Tardive Dyskinesia
• Orofacial Dyskinesias

Interventions

Type	Name	Description
DEVICE	Transcranial ExAblate System	MR Guided Focused Ultrasound

Timeline

• Start date: 2015-05-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2014-09-30
• Last updated: 2025-05-01

Locations

2 sites across 1 country: Canada