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

Recruitment Information:

Seeking volunteers with following diagnosis: PD Study Type: Interventional
Eligible Ages: 18 - 85 Status: Recruiting
Time Since Diagnosis: Less than 60 years Study Focus: Dyskinesia, Tremors

Study Purpose:

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.

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More Details

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).

Phase: N/A Lead Sponsor: InSightec
Trial ID: 004051 Sponsor Type: Industry
Primary Country: Canada Additional Collaborators or Sponsors:
Estimated Enrollment: 10 Study Start Date: May 2015
Estimated Study Completion Date: December 2018 Source: ClinicalTrials.gov
Study Website:

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