Subthalamotomy by ExAblate Transcranial System to Treat Motor Features of Parkinson's Disease
Based on published animal and human studies, ExAblate Transcranial subthalamotomy can be as safe and as effective as any of the surgical treatments within the currently accepted standard of care including radiofrequency lesioning and Deep Brain Stimulation (DBS). A unilateral lesion of the subthalamic nucleus has shown reduction of contralateral motor symptoms in Parkinson's disease (PD). Using ExAblate Transcranial Magnetic Resonance guided High Intensity Focused Ultrasound (MRgHIFU) to create the subthalamotomy has several potential advantages over current therapies including the fact that transcranial lesioning can be performed in a precise manner with simultaneous as well as continuous clinical and radiographic monitoring. If the potential of ExAblate Transcranial subthalamotomy can be realized, it could supplant radiofrequency and radiosurgery techniques and provide a viable alternative procedure for subjects considering DBS.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Clinical Trial of the Feasibility, Safety and Efficacy of Subthalamotomy Using the ExAblate Transcranial System to Treat the Cardinal Motor Features of Parkinson's Disease
Study Start Date: April 2016
Primary Completion Date: January 2017
Study Completion Date: January 2017
- Experimental: MRIgHIFU unilateral subthalamotomy
- Focused ultrasound subthalamotomy in patients with asymmetric Parkinson's disease: a pilot study.
|Date last updated at source||2017-01-31|
|Study start date||2016-04-01|
|Estimated primary completion date||2017-01-01|